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Study of Picoplatin Efficacy After Relapse (SPEAR)

Primary Purpose

Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
picoplatin
best supportive care
Sponsored by
Poniard Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring refractory, chemotherapy, progressed, second-line treatment, small cell lung cancer, best supportive care, picoplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histological or cytological diagnosis of SCLC or combined SCLC/non-small cell lung cancer (NSCLC) defined as SCLC mixed with squamous cell carcinoma, adenocarcinoma, or large cell carcinoma.
  • One and only 1 prior cisplatin or carboplatin-containing chemotherapy regimen for SCLC within the scope of the National Comprehensive Cancer Network (NCCN) Guidelines (Section 5.4.1).
  • Radiological evidence of SCLC that never responded or progressed within 90 days after completion of first-line therapy (refractory); or responded initially to first-line therapy but progressed between 91 and 180 days after treatment was completed (progressed within 91 to 180 days).
  • CT scans of head, chest and abdomen (including adrenal and full extent of liver) with contrast, preferably within 14 days prior to randomization (up to 21 days is allowed if necessary). MRI is acceptable in the case of allergy to contrast agents. The presence or absence of measurable disease gy RECIST must be documented from the baseline CT or MRI scan.
  • Patients with brain metastases must have been treated with brain irradiation. Only patients wtih asymptomatic brain metastases are eligible for this study.
  • ECOG PS 0, 1 or 2 within 3 days prior to randomization (Appendix II).
  • Life expectancy of at least 8 weeks within 3 days prior to randomization.
  • At least 21 days must have elapsed since the most recent prior chemotherapy dose, with evidence of hematological recovery.
  • At least 14 days must have elapsed since the most recent prior radiotherapy dose.
  • At least 14 days must have elapsed since prior surgery except for the placement of venous access device or bronchoscopy.
  • Subject must be recovered to ≤ Grade 1 toxicity from all non-hematological adverse effects of prior therapies (excluding alopecia).
  • Age 18 years or over.
  • ANC ≥ 1.5 x 109/L.
  • Platelet count ≥ 100 x 109/L.
  • Hemoglobin of ≥ 90 g/L (transfusion permitted to achieve this hemoglobin).
  • Aspartate aminotransferase, alanine aminotransferase, and lactate dehydrogenase levels ≤ 2.5 times upper limit of normal (ULN) or ≤ 5 times ULN if liver involvement is present.
  • Bilirubin of ≤ 1.5 times upper limit of normal (ULN).
  • Blood urea nitrogen ≤ 1.5 times ULN (hypovolemic subjects may be hydrated to achieve this BUN).
  • Creatinine clearance of ≥ 50 mL/min, as calculated by the Cockcroft-Gault formula (Appendix III).
  • Women of childbearing potential must have a negative pregnancy test (serum or urine). Sexually active couples of child-bearing potential must agree to use appropriate birth control methods during chemotherapy and for 3 months after chemotherapy.
  • Signed informed consent.

Exclusion Criteria:

  • Prior radiotherapy that included ≥ 30% of the bone marrow (Appendix IV).
  • Pleural effusion as the only radiological evidence of SCLC.
  • Untreated or symptomatic brain or central nervous system (CNS) metastases.
  • Grade 2 or higher peripheral neuropathy.
  • Significant cardiac disease, defined as myocardial infarction within 3 months prior to randomization, congestive heart failure classified by the New York Heart Association as Class III or IV (Appendix V), uncontrolled cardiac arrhythmias, poorly controlled or unstable angina, or electrocardiographic evidence of acute ischemia.
  • Serious medical or psychiatric illness that could potentially interfere with the completion of study treatment according to this protocol, e.g., active infection, Crohn's disease, ulcerative colitis, etc.
  • Use of other investigational drugs within 30 days prior to randomization.
  • Breast-feeding.
  • History of any other malignancy within 5 years, with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix.

Sites / Locations

  • Consultorios Privados
  • Clinica Constituyentes
  • CETEN Centro de Estudio y Tratamiento de Enfermedades Neoplasicas
  • IADT (Insttituto Argentino de Diagnostico y Tratamiento S.A.)
  • Centro Oncologico
  • Instituto Alexander Fleming
  • PALIAR
  • IONC
  • Centro Oncologico de Rosario
  • ISIS Clinica Especializada
  • Centro Medico San Roque
  • Gomel Regional Oncological Dispensary
  • Institution of Healthcare "Grodno Regional Clinical Hospital
  • Minsk City Clinical Oncology Dispensary
  • Research Institute of Oncology and Medical Radiology named by N.N. Aleksandrov
  • Vitebsk Regional Oncology Dispensary
  • Clinic for Lung Diseases, Clinical Center, Banja Luka
  • Clinic of Pulmonary Diseases Podhrastovi
  • Multiprofile Hospital for Active Treatment, Dr. Tota Venkova
  • University Multifunctional Hospital for Active Treatment "Dr. Georgi Stranski"
  • District Dispensary for Cancer Diseases with Inpatient Hospital Plovdiv
  • Regional Oncodispensary with Inpatient Sector
  • Inter-district Dispensary for Cancer Diseases w/Inpatient Hospital
  • Regional Oncodispensary with Inpatient Sector-Sofia District
  • Inter-district Dispensary for Cancer Disease w/Inpatient Hospital "Dr. Marko Markov", Varna
  • Multiprofile Hospital for Active Treatment "St. Marina"
  • Instituto Nacional de Cancer
  • Clinical Hospital
  • Clinical Hospital
  • Clinical Hospital Split
  • Clinic for Pulmonary Diseses "Jordanovac"
  • St. George County Hospital
  • University of Szeged
  • General Rehablitation and Medicinal Bath Hospital
  • Gujrat Cancer Research Institute
  • Kidwai Memorial Institute of Oncology
  • Lakeshore Hospital and Research Center
  • Shatabdi Superspeciality Hospital
  • Curie Centre of Oncology
  • Jawaharlal Nehru Cancer Hospital and Research Centre
  • Apollo Speciality Hospital
  • MNJ Institute of Oncology
  • Indo American Institute of Oncology
  • Yashoda Group of Hospitals
  • SEAROC Cancer Center
  • Institute of Post Graduate Medical Education and Research
  • Orchid Nursing Home
  • King George Medical University
  • KMC (Karturba Medical College) Hospital
  • Jaslok Hospital and Research Centre
  • Tata Memorial Centre
  • Sir Ganga Ram Hospital
  • Rajiv Gandhi Cancer Institute, Delhi
  • Mahaveer Cancer Sansthan
  • Jahangir Hospital and Research Centre
  • Smt. Vasantben R. Desai Cancer Research Center
  • Regional Cancer Centre
  • King George Hospital
  • Daugavas Hospital
  • Paul Stradins Clincial University Hospital
  • Special Hospital for Pulmonary Diseases
  • Dolnoslaskie Centre of Lung Diseases
  • Silesian Medical University in Katowice
  • Kujawsko-Pomorski Centre of Pulmonology
  • NMP, Memorial Voyvodship Hospital
  • Dr. Bieganski Memorial Regional Specialsitic Hospital
  • Regional Hospital, Department of Pulmonary Diseases and Chemotherapy
  • Independent Public Group for Tuberculosis and Lung Disease in Olsztyn
  • Conservative Outpatient Oncology Department, Voyevodship Hospital in Plock
  • Department of Clinical Oncology, Wielkopolskie Centre of Lung Diseases and Tuberculosis
  • Department of Pulmonology, Voyvodship Specialsitic Hospital in Radom
  • SP ZOZ Voyevodship Specialistic Hospital #3
  • Department of Chemotherapy, Prof. A. Sokolowski Memorial Specialistic Hospital in Szczecin
  • Department of Clinical Oncology, SP ZOZ, Yoyvodship Specialistic Hospital
  • Prof. Dr. Ion Chiricuta, Institute of Oncology Cluj-Napoca
  • Baia Mare "Constantin Opris" County Emergency Hospital
  • IANULI Medconsult SRL
  • Bucharest Institute of Oncology
  • Prof. Dr. Ion Chircuta, Oncology Institute
  • Clinical Emergency County Hospital Constanta
  • Medical Oncology Center Iasi
  • Schuller Municipal Hospital Ploiesti-Medical Oncology Department
  • Clinical County Hospital
  • Sf. loan cel Nou, Emergency County Hospital
  • OncoMed
  • Buryatia Republican Oncology Center
  • Regional Oncology Center
  • Republican Oncology Center of the Ministry of Healthcare of Karelia Republic
  • Komi Republican Oncology Center
  • Clinical Oncology Center
  • Kazan Oncology Center
  • Arkhangelsk Regional Clinical Oncology Center
  • Altai Regional Oncology Center
  • Chelyabinsk Regional Oncology Center
  • City Hospital #1
  • Chita Regional Oncology Center
  • Sverdlovsk Regional Oncology Center
  • Regional Oncology Center
  • Regional Oncology Center
  • Ivanovo Regional Oncology Center
  • Republican Clinical Oncology Center of the Republic of Udmurtia
  • Kaluga Regional Oncology Center
  • Regional Clinical Oncology Center
  • Regional Clinical Oncology Center
  • City Oncology Center
  • Krasnodar Clinical Oncology
  • Regional Clinical Hospital #1
  • Kurst Regional Oncology Center
  • Lipetsk Regional Oncology Center
  • Magnitogorsk Clinical Oncology Hospital
  • Blokhin Russian Oncology Research Center
  • Central Clinical Hospital and Outpatient Unit of the Medical Center under the Russian Presidential Administration
  • Semashko Central Clinical Hospital #2 under Russian Railways
  • Novorossiysk Oncology Center
  • City Clinical Hospital #1
  • Medical Radiology Research Center under RAMS
  • Orel Oncology Center
  • Orenburg Regional Clinical Oncology Center
  • Regional Oncology Center
  • Pyatigorsk Affiliate of Stavropol Regional Clinical Oncology Center
  • Ogarev Mordovian State University
  • State Higher Education Institution Saratov State Medical University under the Federal Agency for Healthcare and Social Development
  • Oncology Center
  • St. Petersburg City Multifield Hospital #2
  • St. Petersburg Pavlov State Medical University
  • Pavlov St. Petersburg State Medical University, Pulmonology Research Institute
  • City Clinical Oncology Center, Thoracic Oncology Department #6
  • Tambov Regional Oncology Center
  • Tomsk Regional Oncology Center
  • Tula Regional Oncology Center
  • Ufa, Republican Oncology Center
  • Primorsky Regional Oncology Center
  • Volgograd Regional Clinical Oncology Center#1
  • Voronezh Regional Clinical Oncology Center
  • Regional Clinical Oncology Hospital
  • Republican of Clinical Hospital, Mariy-El Republican
  • Clinic for Pulmonary Diseases and TBC
  • Institute for Pulmonary Diseases of Vijvodina
  • Volyn Regional Oncology Center
  • Public Treatment and Prevention Institution Mariupol City Interdistrict Oncology Center
  • Sumy Regional Oncology Center
  • Ternopol Regional Clinical Oncology Center
  • Zaporozhye Regional Clinical Oncology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Picoplatin

BSC

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

objective response rate
disease control rate
duration of response
progression-free survival

Full Information

First Posted
April 23, 2007
Last Updated
April 13, 2009
Sponsor
Poniard Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00465491
Brief Title
Study of Picoplatin Efficacy After Relapse
Acronym
SPEAR
Official Title
A Randomized, Controlled Phase III Trial of Picoplatin and BSC Versus BSC Alone in Patients With Small Cell Lung Cancer (SCLC), Refractory or Progressive Within Six Months of Completing First-Line, Platinum-Containing Chemotherapy.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Poniard Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Picoplatin is a new type of platinum drug that has been investigated in several clinical trials, and may provide an improved safety profile over current treatment options. This study is designed to compare the efficacy and safety of picoplatin plus Best Supportive Care (BSC) with BSC alone. Best Supportive Care includes care and treatment to optimize the comfort of patients and their ability to function, as well as to minimize the side-effects of anti-cancer treatments.
Detailed Description
This Phase 3 study will enroll subjects with Small Cell Lung Cancer (SCLC) who are refractory or progressive within 6 months of completing first-line, platinum-containing chemotherapy. Subjects will be centrally randomized 2:1 to receive picoplatin plus BSC every 3 weeks, or BSC alone. After discontinuation of picoplatin, all subjects will continue to receive BSC and will continue to be evaluated every 3 weeks until discontinuation from the study, death, or the end of the study. After discontinuation of picoplatin, subjects may be treated with another chemotherapy at their physician's discretion and then will be followed for survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
refractory, chemotherapy, progressed, second-line treatment, small cell lung cancer, best supportive care, picoplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
399 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Picoplatin
Arm Title
2
Arm Type
Other
Arm Description
BSC
Intervention Type
Drug
Intervention Name(s)
picoplatin
Intervention Description
IV picoplatin 150mg/m2 q3wk
Intervention Type
Other
Intervention Name(s)
best supportive care
Intervention Description
best supportive care
Primary Outcome Measure Information:
Title
overall survival
Time Frame
death
Secondary Outcome Measure Information:
Title
objective response rate
Time Frame
progression
Title
disease control rate
Time Frame
progression
Title
duration of response
Time Frame
progression
Title
progression-free survival
Time Frame
death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological or cytological diagnosis of SCLC or combined SCLC/non-small cell lung cancer (NSCLC) defined as SCLC mixed with squamous cell carcinoma, adenocarcinoma, or large cell carcinoma. One and only 1 prior cisplatin or carboplatin-containing chemotherapy regimen for SCLC within the scope of the National Comprehensive Cancer Network (NCCN) Guidelines (Section 5.4.1). Radiological evidence of SCLC that never responded or progressed within 90 days after completion of first-line therapy (refractory); or responded initially to first-line therapy but progressed between 91 and 180 days after treatment was completed (progressed within 91 to 180 days). CT scans of head, chest and abdomen (including adrenal and full extent of liver) with contrast, preferably within 14 days prior to randomization (up to 21 days is allowed if necessary). MRI is acceptable in the case of allergy to contrast agents. The presence or absence of measurable disease gy RECIST must be documented from the baseline CT or MRI scan. Patients with brain metastases must have been treated with brain irradiation. Only patients wtih asymptomatic brain metastases are eligible for this study. ECOG PS 0, 1 or 2 within 3 days prior to randomization (Appendix II). Life expectancy of at least 8 weeks within 3 days prior to randomization. At least 21 days must have elapsed since the most recent prior chemotherapy dose, with evidence of hematological recovery. At least 14 days must have elapsed since the most recent prior radiotherapy dose. At least 14 days must have elapsed since prior surgery except for the placement of venous access device or bronchoscopy. Subject must be recovered to ≤ Grade 1 toxicity from all non-hematological adverse effects of prior therapies (excluding alopecia). Age 18 years or over. ANC ≥ 1.5 x 109/L. Platelet count ≥ 100 x 109/L. Hemoglobin of ≥ 90 g/L (transfusion permitted to achieve this hemoglobin). Aspartate aminotransferase, alanine aminotransferase, and lactate dehydrogenase levels ≤ 2.5 times upper limit of normal (ULN) or ≤ 5 times ULN if liver involvement is present. Bilirubin of ≤ 1.5 times upper limit of normal (ULN). Blood urea nitrogen ≤ 1.5 times ULN (hypovolemic subjects may be hydrated to achieve this BUN). Creatinine clearance of ≥ 50 mL/min, as calculated by the Cockcroft-Gault formula (Appendix III). Women of childbearing potential must have a negative pregnancy test (serum or urine). Sexually active couples of child-bearing potential must agree to use appropriate birth control methods during chemotherapy and for 3 months after chemotherapy. Signed informed consent. Exclusion Criteria: Prior radiotherapy that included ≥ 30% of the bone marrow (Appendix IV). Pleural effusion as the only radiological evidence of SCLC. Untreated or symptomatic brain or central nervous system (CNS) metastases. Grade 2 or higher peripheral neuropathy. Significant cardiac disease, defined as myocardial infarction within 3 months prior to randomization, congestive heart failure classified by the New York Heart Association as Class III or IV (Appendix V), uncontrolled cardiac arrhythmias, poorly controlled or unstable angina, or electrocardiographic evidence of acute ischemia. Serious medical or psychiatric illness that could potentially interfere with the completion of study treatment according to this protocol, e.g., active infection, Crohn's disease, ulcerative colitis, etc. Use of other investigational drugs within 30 days prior to randomization. Breast-feeding. History of any other malignancy within 5 years, with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Hazel Breitz, M.D.
Organizational Affiliation
Poniard Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Consultorios Privados
City
Buenos Aires
ZIP/Postal Code
B1704ESN
Country
Argentina
Facility Name
Clinica Constituyentes
City
Buenos Aires
ZIP/Postal Code
B1708KCH
Country
Argentina
Facility Name
CETEN Centro de Estudio y Tratamiento de Enfermedades Neoplasicas
City
Buenos Aires
ZIP/Postal Code
B1874ACL
Country
Argentina
Facility Name
IADT (Insttituto Argentino de Diagnostico y Tratamiento S.A.)
City
Buenos Aires
ZIP/Postal Code
C1122AAL
Country
Argentina
Facility Name
Centro Oncologico
City
Buenos Aires
ZIP/Postal Code
C1212ACA
Country
Argentina
Facility Name
Instituto Alexander Fleming
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
PALIAR
City
Buenos Aires
ZIP/Postal Code
C1430ERF
Country
Argentina
Facility Name
IONC
City
Cordoba
ZIP/Postal Code
X5000AAI
Country
Argentina
Facility Name
Centro Oncologico de Rosario
City
Santa Fe
ZIP/Postal Code
S2000DSK
Country
Argentina
Facility Name
ISIS Clinica Especializada
City
Santa Fe
ZIP/Postal Code
S3002EKI
Country
Argentina
Facility Name
Centro Medico San Roque
City
Tucuman
ZIP/Postal Code
T4000IAA
Country
Argentina
Facility Name
Gomel Regional Oncological Dispensary
City
Gomel
ZIP/Postal Code
246012
Country
Belarus
Facility Name
Institution of Healthcare "Grodno Regional Clinical Hospital
City
Grodno
ZIP/Postal Code
230017
Country
Belarus
Facility Name
Minsk City Clinical Oncology Dispensary
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
Research Institute of Oncology and Medical Radiology named by N.N. Aleksandrov
City
Minsk
ZIP/Postal Code
223040
Country
Belarus
Facility Name
Vitebsk Regional Oncology Dispensary
City
Vitebsk
ZIP/Postal Code
210603
Country
Belarus
Facility Name
Clinic for Lung Diseases, Clinical Center, Banja Luka
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Clinic of Pulmonary Diseases Podhrastovi
City
Sarajevo
Country
Bosnia and Herzegovina
Facility Name
Multiprofile Hospital for Active Treatment, Dr. Tota Venkova
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
University Multifunctional Hospital for Active Treatment "Dr. Georgi Stranski"
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
District Dispensary for Cancer Diseases with Inpatient Hospital Plovdiv
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Regional Oncodispensary with Inpatient Sector
City
Rousse
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
Inter-district Dispensary for Cancer Diseases w/Inpatient Hospital
City
Shumen
ZIP/Postal Code
9700
Country
Bulgaria
Facility Name
Regional Oncodispensary with Inpatient Sector-Sofia District
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Inter-district Dispensary for Cancer Disease w/Inpatient Hospital "Dr. Marko Markov", Varna
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "St. Marina"
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Instituto Nacional de Cancer
City
Santiago
ZIP/Postal Code
2363058
Country
Chile
Facility Name
Clinical Hospital
City
Dubrovnik
Country
Croatia
Facility Name
Clinical Hospital
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Clinical Hospital Split
City
Split
ZIP/Postal Code
2001
Country
Croatia
Facility Name
Clinic for Pulmonary Diseses "Jordanovac"
City
Zagreb
Country
Croatia
Facility Name
St. George County Hospital
City
Fejer County
ZIP/Postal Code
8000
Country
Hungary
Facility Name
University of Szeged
City
Szeged
ZIP/Postal Code
6772
Country
Hungary
Facility Name
General Rehablitation and Medicinal Bath Hospital
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Gujrat Cancer Research Institute
City
Asarwa
State/Province
Ahmadabad
ZIP/Postal Code
380016
Country
India
Facility Name
Kidwai Memorial Institute of Oncology
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560029
Country
India
Facility Name
Lakeshore Hospital and Research Center
City
Kochin
State/Province
Kerala
ZIP/Postal Code
682304
Country
India
Facility Name
Shatabdi Superspeciality Hospital
City
Nasik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Facility Name
Curie Centre of Oncology
City
Bangalore
ZIP/Postal Code
560034
Country
India
Facility Name
Jawaharlal Nehru Cancer Hospital and Research Centre
City
Bhopal
Country
India
Facility Name
Apollo Speciality Hospital
City
Chennai
ZIP/Postal Code
600035
Country
India
Facility Name
MNJ Institute of Oncology
City
Hyderabaad
ZIP/Postal Code
500004
Country
India
Facility Name
Indo American Institute of Oncology
City
Hyderabaad
ZIP/Postal Code
500034
Country
India
Facility Name
Yashoda Group of Hospitals
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
SEAROC Cancer Center
City
Jaipur
ZIP/Postal Code
302013
Country
India
Facility Name
Institute of Post Graduate Medical Education and Research
City
Kolkata
ZIP/Postal Code
700020
Country
India
Facility Name
Orchid Nursing Home
City
Kolkata
ZIP/Postal Code
700054
Country
India
Facility Name
King George Medical University
City
Lucknow
Country
India
Facility Name
KMC (Karturba Medical College) Hospital
City
Manipal
Country
India
Facility Name
Jaslok Hospital and Research Centre
City
Mumbai
ZIP/Postal Code
400026
Country
India
Facility Name
Tata Memorial Centre
City
Mumbai
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Rajiv Gandhi Cancer Institute, Delhi
City
New Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Mahaveer Cancer Sansthan
City
Patna
ZIP/Postal Code
801505
Country
India
Facility Name
Jahangir Hospital and Research Centre
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Smt. Vasantben R. Desai Cancer Research Center
City
Rajkot
ZIP/Postal Code
360007
Country
India
Facility Name
Regional Cancer Centre
City
Trivandrum
ZIP/Postal Code
695011
Country
India
Facility Name
King George Hospital
City
Vishakhapatnam
Country
India
Facility Name
Daugavas Hospital
City
Daugavpils
ZIP/Postal Code
5420
Country
Latvia
Facility Name
Paul Stradins Clincial University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Special Hospital for Pulmonary Diseases
City
Niksic
ZIP/Postal Code
81400
Country
Montenegro
Facility Name
Dolnoslaskie Centre of Lung Diseases
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-439
Country
Poland
Facility Name
Silesian Medical University in Katowice
City
Zabrze
State/Province
Dolny Slask
ZIP/Postal Code
41-803
Country
Poland
Facility Name
Kujawsko-Pomorski Centre of Pulmonology
City
Bydgoszcz
ZIP/Postal Code
85-326
Country
Poland
Facility Name
NMP, Memorial Voyvodship Hospital
City
Czestochowa
ZIP/Postal Code
42200
Country
Poland
Facility Name
Dr. Bieganski Memorial Regional Specialsitic Hospital
City
Grudziadz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
Regional Hospital, Department of Pulmonary Diseases and Chemotherapy
City
Krakow
ZIP/Postal Code
31202
Country
Poland
Facility Name
Independent Public Group for Tuberculosis and Lung Disease in Olsztyn
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Conservative Outpatient Oncology Department, Voyevodship Hospital in Plock
City
Plock
ZIP/Postal Code
09-400
Country
Poland
Facility Name
Department of Clinical Oncology, Wielkopolskie Centre of Lung Diseases and Tuberculosis
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Department of Pulmonology, Voyvodship Specialsitic Hospital in Radom
City
Radom
ZIP/Postal Code
26-617
Country
Poland
Facility Name
SP ZOZ Voyevodship Specialistic Hospital #3
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Facility Name
Department of Chemotherapy, Prof. A. Sokolowski Memorial Specialistic Hospital in Szczecin
City
Szczecin
ZIP/Postal Code
70-891
Country
Poland
Facility Name
Department of Clinical Oncology, SP ZOZ, Yoyvodship Specialistic Hospital
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Prof. Dr. Ion Chiricuta, Institute of Oncology Cluj-Napoca
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Baia Mare "Constantin Opris" County Emergency Hospital
City
Baia Mare
State/Province
Maramures County
ZIP/Postal Code
4800
Country
Romania
Facility Name
IANULI Medconsult SRL
City
Bucharest
ZIP/Postal Code
020962
Country
Romania
Facility Name
Bucharest Institute of Oncology
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Prof. Dr. Ion Chircuta, Oncology Institute
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Clinical Emergency County Hospital Constanta
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Medical Oncology Center Iasi
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Schuller Municipal Hospital Ploiesti-Medical Oncology Department
City
Ploiesti
ZIP/Postal Code
100337
Country
Romania
Facility Name
Clinical County Hospital
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Sf. loan cel Nou, Emergency County Hospital
City
Suceava
Country
Romania
Facility Name
OncoMed
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Facility Name
Buryatia Republican Oncology Center
City
Ulan-Ude
State/Province
Buryatia
ZIP/Postal Code
670047
Country
Russian Federation
Facility Name
Regional Oncology Center
City
Birobidzhan
State/Province
Jewish Republic
ZIP/Postal Code
679016
Country
Russian Federation
Facility Name
Republican Oncology Center of the Ministry of Healthcare of Karelia Republic
City
Petrozavodsk
State/Province
Karelia Republic
ZIP/Postal Code
185007
Country
Russian Federation
Facility Name
Komi Republican Oncology Center
City
Syktyvkar
State/Province
Komi Republic
ZIP/Postal Code
167904
Country
Russian Federation
Facility Name
Clinical Oncology Center
City
Kazan
State/Province
Tatarstan Republic
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Kazan Oncology Center
City
Kazan
State/Province
Tatarstan Republic
ZIP/Postal Code
420111
Country
Russian Federation
Facility Name
Arkhangelsk Regional Clinical Oncology Center
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Altai Regional Oncology Center
City
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
Facility Name
Chelyabinsk Regional Oncology Center
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
City Hospital #1
City
Cherepovets
ZIP/Postal Code
162627
Country
Russian Federation
Facility Name
Chita Regional Oncology Center
City
Chita
ZIP/Postal Code
672027
Country
Russian Federation
Facility Name
Sverdlovsk Regional Oncology Center
City
Ekaterinburg
ZIP/Postal Code
620036
Country
Russian Federation
Facility Name
Regional Oncology Center
City
Engels
ZIP/Postal Code
413115
Country
Russian Federation
Facility Name
Regional Oncology Center
City
Irkutsk
ZIP/Postal Code
664035
Country
Russian Federation
Facility Name
Ivanovo Regional Oncology Center
City
Ivanovo
ZIP/Postal Code
214000
Country
Russian Federation
Facility Name
Republican Clinical Oncology Center of the Republic of Udmurtia
City
Izhevsk
ZIP/Postal Code
426009
Country
Russian Federation
Facility Name
Kaluga Regional Oncology Center
City
Kaluga
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
Regional Clinical Oncology Center
City
Khabarovsk
ZIP/Postal Code
680042
Country
Russian Federation
Facility Name
Regional Clinical Oncology Center
City
Kirov
ZIP/Postal Code
610021
Country
Russian Federation
Facility Name
City Oncology Center
City
Komsomolsk-na-Amure
ZIP/Postal Code
681000
Country
Russian Federation
Facility Name
Krasnodar Clinical Oncology
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Regional Clinical Hospital #1
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
Kurst Regional Oncology Center
City
Kurst
Country
Russian Federation
Facility Name
Lipetsk Regional Oncology Center
City
Lipetsk
ZIP/Postal Code
398005
Country
Russian Federation
Facility Name
Magnitogorsk Clinical Oncology Hospital
City
Magnitogorsk
ZIP/Postal Code
455001
Country
Russian Federation
Facility Name
Blokhin Russian Oncology Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Central Clinical Hospital and Outpatient Unit of the Medical Center under the Russian Presidential Administration
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Semashko Central Clinical Hospital #2 under Russian Railways
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Novorossiysk Oncology Center
City
Novorossiysk
ZIP/Postal Code
353915
Country
Russian Federation
Facility Name
City Clinical Hospital #1
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Medical Radiology Research Center under RAMS
City
Obnninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Orel Oncology Center
City
Orel
ZIP/Postal Code
302020
Country
Russian Federation
Facility Name
Orenburg Regional Clinical Oncology Center
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
Regional Oncology Center
City
Penza
ZIP/Postal Code
440071
Country
Russian Federation
Facility Name
Pyatigorsk Affiliate of Stavropol Regional Clinical Oncology Center
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Ogarev Mordovian State University
City
Saransk
ZIP/Postal Code
430032
Country
Russian Federation
Facility Name
State Higher Education Institution Saratov State Medical University under the Federal Agency for Healthcare and Social Development
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Oncology Center
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
St. Petersburg City Multifield Hospital #2
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
St. Petersburg Pavlov State Medical University
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Pavlov St. Petersburg State Medical University, Pulmonology Research Institute
City
St. Petersburg
ZIP/Postal Code
197101
Country
Russian Federation
Facility Name
City Clinical Oncology Center, Thoracic Oncology Department #6
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Tambov Regional Oncology Center
City
Tambov
ZIP/Postal Code
390013
Country
Russian Federation
Facility Name
Tomsk Regional Oncology Center
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Tula Regional Oncology Center
City
Tula
ZIP/Postal Code
300040
Country
Russian Federation
Facility Name
Ufa, Republican Oncology Center
City
Ufa
Country
Russian Federation
Facility Name
Primorsky Regional Oncology Center
City
Vladivostok
ZIP/Postal Code
690105
Country
Russian Federation
Facility Name
Volgograd Regional Clinical Oncology Center#1
City
Volograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Voronezh Regional Clinical Oncology Center
City
Voronezh
ZIP/Postal Code
394000
Country
Russian Federation
Facility Name
Regional Clinical Oncology Hospital
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Republican of Clinical Hospital, Mariy-El Republican
City
Yoshkar-Ola
ZIP/Postal Code
424037
Country
Russian Federation
Facility Name
Clinic for Pulmonary Diseases and TBC
City
Knez Selo
Country
Serbia
Facility Name
Institute for Pulmonary Diseases of Vijvodina
City
Vijvodina
Country
Serbia
Facility Name
Volyn Regional Oncology Center
City
Lutsk
ZIP/Postal Code
43018
Country
Ukraine
Facility Name
Public Treatment and Prevention Institution Mariupol City Interdistrict Oncology Center
City
Mariupol
ZIP/Postal Code
87500
Country
Ukraine
Facility Name
Sumy Regional Oncology Center
City
Sumy
ZIP/Postal Code
40005
Country
Ukraine
Facility Name
Ternopol Regional Clinical Oncology Center
City
Ternopol
ZIP/Postal Code
46023
Country
Ukraine
Facility Name
Zaporozhye Regional Clinical Oncology Center
City
Zaporozhye
ZIP/Postal Code
69040
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
9815598
Citation
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Gore ME, Atkinson RJ, Thomas H, Cure H, Rischin D, Beale P, Bougnoux P, Dirix L, Smit WM. Results of ZD0473 in platinum-pretreated ovarian cancer: analysis according to platinum free interval. Eur J Cancer. 2002 Dec;38 Suppl 8:S7-12. doi: 10.1016/s0959-8049(02)80014-4.
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Holford J, Raynaud F, Murrer BA, Grimaldi K, Hartley JA, Abrams M, Kelland LR. Chemical, biochemical and pharmacological activity of the novel sterically hindered platinum co-ordination complex, cis-[amminedichloro(2-methylpyridine)] platinum(II) (AMD473). Anticancer Drug Des. 1998 Jan;13(1):1-18.
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Holford J, Sharp SY, Murrer BA, Abrams M, Kelland LR. In vitro circumvention of cisplatin resistance by the novel sterically hindered platinum complex AMD473. Br J Cancer. 1998;77(3):366-73. doi: 10.1038/bjc.1998.59.
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Rogers P, Boxall FE, Allott CP, Stephens TC, Kelland LR. Sequence-dependent synergism between the new generation platinum agent ZD0473 and paclitaxel in cisplatin-sensitive and -resistant human ovarian carcinoma cell lines. Eur J Cancer. 2002 Aug;38(12):1653-60. doi: 10.1016/s0959-8049(02)00107-7.
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Sharp SY, O'Neill CF, Rogers P, Boxall FE, Kelland LR. Retention of activity by the new generation platinum agent AMD0473 in four human tumour cell lines possessing acquired resistance to oxaliplatin. Eur J Cancer. 2002 Nov;38(17):2309-15. doi: 10.1016/s0959-8049(02)00244-7.
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Links:
URL
http://www.poniard.com
Description
Poniard Pharmaceuticals, Inc.

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Study of Picoplatin Efficacy After Relapse

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