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Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes

Primary Purpose

Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
vatalanib
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory cytopenia with multilineage dysplasia, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasm, unclassifiable, refractory anemia, previously treated myelodysplastic syndromes

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Diagnosis of primary or secondary (therapy-related) myelodysplastic syndromes* (MDS), including the following cellular types: Refractory anemia (RA)** RA with excess blasts (RAEB)-1 RA with ringed sideroblasts** Refractory cytopenia with multilineage dysplasia Refractory cytopenia with multilineage dysplasia with ringed sideroblasts* MDS-unclassified** MDS associated with isolated del (5q)** Chronic myelomonocytic leukemia (CMML)-1 NOTE: *High-risk MDS (i.e., RAEB-2 or CMML-2) is closed to accrual as of 11/30/06 NOTE: **Accompanied with at least 1 of the following laboratory values: hemoglobin less than 10 g/dL, platelet count less than 50,000/mm3, or absolute neutrophil count less than 1,000/mm3 No prior leukemia (i.e., 20% or greater blasts) No prior primary or metastatic brain tumor or carcinomatous meningitis PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 2.5 times ULN APTT no greater than 1.5 times ULN INR no greater than 1.5 Renal Creatinine no greater than 1.5 times ULN Urine protein negative by urinalysis Protein 1+ by dipstick allowed provided total urine protein no greater than 500 mg AND creatinine clearance at least 50 mL/min by 24-hour urine collection Cardiovascular No significant cardiac or vascular events within the past 6 months, including any of the following: Acute myocardial infarction Unstable angina Uncontrolled hypertension Severe peripheral vascular disease (e.g., ischemic pain at rest or nonhealing ulcers or wounds) New York Heart Association class II-IV congestive heart failure Cardiac arrhythmia Disseminated intravascular coagulation or other coagulopathies Deep vein or arterial thrombosis No history of congenital long QTc syndrome or elongated QTc (> 450 msec for males or 470 for females) Pulmonary No pulmonary embolism within the past 6 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for at least 3 months after study participation No need for full anticoagulation within the past 6 months No significant hemorrhage (e.g., visceral, gastrointestinal, genitourinary, or gynecological) requiring red blood cell transfusion within the past month No known cerebral aneurysms, other cerebrovascular malformations, or CNS bleeding No unhealed fractures, wounds, or ulcers PRIOR CONCURRENT THERAPY: Biologic therapy More than 12 months since prior autologous stem cell or allogeneic transplantation More than 6 months since prior antiangiogenic agents More than 1 month since prior interferon for MDS More than 1 month since prior hematopoietic growth factors for MDS More than 1 month since prior epoetin alfa (EPO) for MDS More than 1 month since prior thalidomide for MDS More than 1 month since prior immunotherapy for MDS No concurrent prophylactic growth factors or cytokines (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], EPO or EPO-derivatives, or interleukin-11) Chemotherapy No prior low-dose antimetabolites for MDS (e.g., hydroxyurea, azacitidine, or low-dose cytarabine) More than 12 months since prior chemotherapy for another disease* NOTE: *Not MDS or leukemia Endocrine therapy More than 1 month since prior corticosteroids for MDS More than 1 month since prior androgens for MDS Radiotherapy More than 12 months since prior radiotherapy for another disease* NOTE: *Not MDS or leukemia Surgery More than 1 month since prior surgery, including needle biopsy of visceral organs and recovered Bone marrow biopsy allowed More than 2 weeks since prior placement of a subcutaneous or tunneled venous access device (e.g., PortaCath or Hickman's catheter) and adequately healed Other No prior cytotoxic therapy for MDS More than 1 month since prior administration of any of the following medications for MDS: Danazol Retinoids Amifostine Investigational agents No concurrent administration of any of the following medications: Warfarin Heparin Derivatives of heparin Other anticoagulants No concurrent grapefruit or grapefruit juice

Sites / Locations

  • Tunnell Cancer Center at Beebe Medical Center
  • CCOP - Christiana Care Health Services
  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
  • CCOP - Mount Sinai Medical Center
  • Graham Hospital
  • Memorial Hospital
  • Eureka Community Hospital
  • Evanston Northwestern Healthcare - Evanston Hospital
  • Galesburg Clinic, PC
  • Galesburg Cottage Hospital
  • Mason District Hospital
  • Hopedale Medical Complex
  • McDonough District Hospital
  • BroMenn Regional Medical Center
  • Community Cancer Center
  • Community Hospital of Ottawa
  • Oncology Hematology Associates of Central Illinois, PC - Ottawa
  • Cancer Treatment Center at Pekin Hospital
  • Proctor Hospital
  • CCOP - Illinois Oncology Research Association
  • Oncology Hematology Associates of Central Illinois, PC - Peoria
  • Methodist Medical Center of Illinois
  • Illinois Valley Community Hospital
  • Perry Memorial Hospital
  • Center for Cancer Care at OSF Saint Anthony Medical Center
  • St. Margaret's Hospital
  • Elkhart General Hospital
  • Fort Wayne Medical Oncology and Hematology
  • CCOP - Northern Indiana CR Consortium
  • Memorial Hospital of South Bend
  • Central Maine Comprehensive Cancer Center at Central Maine Medical Center
  • Union Hospital Cancer Program at Union Hospital
  • Lakeland Regional Cancer Care Center - St. Joseph
  • Veterans Affairs Medical Center - Minneapolis
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
  • CCOP - Kansas City
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  • Callahan Cancer Center at Great Plains Regional Medical Center
  • CCOP - Missouri Valley Cancer Consortium
  • Methodist Estabrook Cancer Center
  • Immanuel Medical Center
  • Alegant Health Cancer Center at Bergan Mercy Medical Center
  • Creighton University Medical Center
  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  • Cancer Institute of New Jersey at Cooper - Voorhees
  • Roswell Park Cancer Institute
  • Don Monti Comprehensive Cancer Center at North Shore University Hospital
  • Long Island Jewish Medical Center
  • Mount Sinai Medical Center
  • SUNY Upstate Medical University Hospital
  • Veterans Affairs Medical Center - Syracuse
  • Faxton Regional Cancer Center
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Presbyterian Cancer Center at Presbyterian Hospital
  • Duke Comprehensive Cancer Center
  • Wayne Memorial Hospital, Incorporated
  • Pardee Memorial Hospital
  • Kinston Medical Specialists
  • Wake Forest University Comprehensive Cancer Center
  • Oklahoma University Cancer Institute
  • Cancer Care Associates - Mercy Campus
  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
  • Rhode Island Hospital Comprehensive Cancer Center
  • Miriam Hospital
  • Mountainview Medical
  • Fletcher Allen Health Care - University Health Center Campus
  • Danville Regional Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vatalanib

Arm Description

Adult patients with MDS receive treatment with vatalanib.

Outcomes

Primary Outcome Measures

Number of Participants With Response
Response was measured by International Standardized Response Criteria for MDS Complete Response: Bone marrow showing < 5% myeloblasts with normal maturation of all cell lines; Hgb > 11 g/dL (untransfused), ANC ≥1.5 K/L, PLT ≥ 100 K/L, No blasts, no dysplasia Partial remission: All of the CR criteria (if abnormal at baseline), except BM evaluation. Blasts decreased by ≥ 50% over baseline. Cellularity and morphology are not relevant. Hematologic improvement: Erythroid (HI-E): For participants with baseline HGB < 11g/dL, Major: > 2g/dL increase, transfusion independence. Minor: 1-2g/dL increase, ≥ 50% decrease in transfusion requirements Platelet (HI-P): For participants with baseline PLT < 100 K/L: Major: absolute increase of > 30 K/L, transfusion independence. Minor: ≥ 50% increase (net increase of >10 K/L) Neutrophil (HI-N): For participants with baseline ANC < 1.5 K/L, Major: > 100% increase (net increase > 0.5 K/L). Minor: > 100% increase (absolute increase < 0.5 K/L)
Time to Transformation to AML
Time to transformation to AML is defined as the time from registration to the transformation of MDS to AML or death of any cause. Participants not meeting these criteria were censored at the date of last follow-up. This outcome was estimated using the Kaplan Meier method.

Secondary Outcome Measures

Duration of Response
Duration of response (DOR) was defined as the time from response (complete remission, partial remission or hematologic improvement) to progression or death of any cause. Responding and alive patients were censored at the date of last follow-up. The median DOR with 95% CI was estimated using the Kaplan Meier method. Response was measured by International Standardized Response Criteria for MDS (described in above outcome measure).
Overall Survival
Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.
Progression-free Survival
Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last clinical assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method. Progression is defined as For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts For patients with 10-19% bone marrow blasts: increase to ≥20% blasts One or more of the following: 50% or greater decrement from maximum remission/response levels in ANC < 1.5 K/L or PLT< 100 K/L, or reduction in HGB by at least 2 g/dL or becoming transfusion dependent Progression after HI: Includes one or more of the following Decrement of 50% or greater from maximum response levels in ANC < 1.5 K/L or PLT < 100 K/L Reduction in HGB concentration by at least 2 g/dL Becoming transfusion dependent

Full Information

First Posted
November 4, 2003
Last Updated
July 1, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00072475
Brief Title
Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes
Official Title
A Phase II Study of an Oral VEGF Receptor Tyrosine Kinase Inhibitor (PTK787/ZK222584) (IND #66370, NSC #719335) in Myelodysplastic Syndrome (MDS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Vatalanib may be effective in preventing the development of leukemia in patients who have myelodysplastic syndromes. PURPOSE: This phase II trial is studying vatalanib to see how well it works in treating patients with primary or secondary myelodysplastic syndromes.
Detailed Description
OBJECTIVES: Primary Determine the response rate, in terms of hematologic improvement and complete and partial remission, in patients with primary or secondary (therapy-related) myelodysplastic syndromes treated with vatalanib. Determine the time to transformation to acute myeloid leukemia (at least 20% blasts) or death in patients treated with this drug. Secondary Determine the safety of this drug in these patients. Determine the duration of response in patients treated with this drug. Determine the cytogenetic response rate in patients treated with this drug. Determine the overall and progression-free survival of patients treated with this drug. Determine the incidence of infections requiring antibiotics or hospitalization or bleeding requiring red blood cell transfusions in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified* according to risk group (low grade [refractory anemia with or without ringed sideroblasts, refractory anemia with excess blasts-1, refractory cytopenia with multilineage dysplasia with or without ringed sideroblasts, myelodysplastic syndromes-unclassified, or chronic myelomonocytic leukemia-1] vs high grade [refractory anemia with excess blasts-2 or chronic myelomonocytic leukemia-2]). NOTE: *Stratification according to risk (low vs high) does not occur after 11/30/06. Patients receive oral vatalanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 6 additional courses after documentation of a CR. Patients are followed periodically for up to 5 years from study entry. PROJECTED ACCRUAL: Approximately 144 patients will be accrued for this study within 2.5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
Keywords
refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory cytopenia with multilineage dysplasia, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasm, unclassifiable, refractory anemia, previously treated myelodysplastic syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vatalanib
Arm Type
Experimental
Arm Description
Adult patients with MDS receive treatment with vatalanib.
Intervention Type
Drug
Intervention Name(s)
vatalanib
Other Intervention Name(s)
PTK787/ZK 222584
Intervention Description
Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)
Primary Outcome Measure Information:
Title
Number of Participants With Response
Description
Response was measured by International Standardized Response Criteria for MDS Complete Response: Bone marrow showing < 5% myeloblasts with normal maturation of all cell lines; Hgb > 11 g/dL (untransfused), ANC ≥1.5 K/L, PLT ≥ 100 K/L, No blasts, no dysplasia Partial remission: All of the CR criteria (if abnormal at baseline), except BM evaluation. Blasts decreased by ≥ 50% over baseline. Cellularity and morphology are not relevant. Hematologic improvement: Erythroid (HI-E): For participants with baseline HGB < 11g/dL, Major: > 2g/dL increase, transfusion independence. Minor: 1-2g/dL increase, ≥ 50% decrease in transfusion requirements Platelet (HI-P): For participants with baseline PLT < 100 K/L: Major: absolute increase of > 30 K/L, transfusion independence. Minor: ≥ 50% increase (net increase of >10 K/L) Neutrophil (HI-N): For participants with baseline ANC < 1.5 K/L, Major: > 100% increase (net increase > 0.5 K/L). Minor: > 100% increase (absolute increase < 0.5 K/L)
Time Frame
Duration of study (up to 5 years)
Title
Time to Transformation to AML
Description
Time to transformation to AML is defined as the time from registration to the transformation of MDS to AML or death of any cause. Participants not meeting these criteria were censored at the date of last follow-up. This outcome was estimated using the Kaplan Meier method.
Time Frame
Duration of study (up to 5 years)
Secondary Outcome Measure Information:
Title
Duration of Response
Description
Duration of response (DOR) was defined as the time from response (complete remission, partial remission or hematologic improvement) to progression or death of any cause. Responding and alive patients were censored at the date of last follow-up. The median DOR with 95% CI was estimated using the Kaplan Meier method. Response was measured by International Standardized Response Criteria for MDS (described in above outcome measure).
Time Frame
5 yrs
Title
Overall Survival
Description
Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.
Time Frame
Duration of study (up to 5 years)
Title
Progression-free Survival
Description
Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last clinical assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method. Progression is defined as For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts For patients with 10-19% bone marrow blasts: increase to ≥20% blasts One or more of the following: 50% or greater decrement from maximum remission/response levels in ANC < 1.5 K/L or PLT< 100 K/L, or reduction in HGB by at least 2 g/dL or becoming transfusion dependent Progression after HI: Includes one or more of the following Decrement of 50% or greater from maximum response levels in ANC < 1.5 K/L or PLT < 100 K/L Reduction in HGB concentration by at least 2 g/dL Becoming transfusion dependent
Time Frame
Duration of study (up to 5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of primary or secondary (therapy-related) myelodysplastic syndromes* (MDS), including the following cellular types: Refractory anemia (RA)** RA with excess blasts (RAEB)-1 RA with ringed sideroblasts** Refractory cytopenia with multilineage dysplasia Refractory cytopenia with multilineage dysplasia with ringed sideroblasts* MDS-unclassified** MDS associated with isolated del (5q)** Chronic myelomonocytic leukemia (CMML)-1 NOTE: *High-risk MDS (i.e., RAEB-2 or CMML-2) is closed to accrual as of 11/30/06 NOTE: **Accompanied with at least 1 of the following laboratory values: hemoglobin less than 10 g/dL, platelet count less than 50,000/mm3, or absolute neutrophil count less than 1,000/mm3 No prior leukemia (i.e., 20% or greater blasts) No prior primary or metastatic brain tumor or carcinomatous meningitis PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 2.5 times ULN APTT no greater than 1.5 times ULN INR no greater than 1.5 Renal Creatinine no greater than 1.5 times ULN Urine protein negative by urinalysis Protein 1+ by dipstick allowed provided total urine protein no greater than 500 mg AND creatinine clearance at least 50 mL/min by 24-hour urine collection Cardiovascular No significant cardiac or vascular events within the past 6 months, including any of the following: Acute myocardial infarction Unstable angina Uncontrolled hypertension Severe peripheral vascular disease (e.g., ischemic pain at rest or nonhealing ulcers or wounds) New York Heart Association class II-IV congestive heart failure Cardiac arrhythmia Disseminated intravascular coagulation or other coagulopathies Deep vein or arterial thrombosis No history of congenital long QTc syndrome or elongated QTc (> 450 msec for males or 470 for females) Pulmonary No pulmonary embolism within the past 6 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for at least 3 months after study participation No need for full anticoagulation within the past 6 months No significant hemorrhage (e.g., visceral, gastrointestinal, genitourinary, or gynecological) requiring red blood cell transfusion within the past month No known cerebral aneurysms, other cerebrovascular malformations, or CNS bleeding No unhealed fractures, wounds, or ulcers PRIOR CONCURRENT THERAPY: Biologic therapy More than 12 months since prior autologous stem cell or allogeneic transplantation More than 6 months since prior antiangiogenic agents More than 1 month since prior interferon for MDS More than 1 month since prior hematopoietic growth factors for MDS More than 1 month since prior epoetin alfa (EPO) for MDS More than 1 month since prior thalidomide for MDS More than 1 month since prior immunotherapy for MDS No concurrent prophylactic growth factors or cytokines (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], EPO or EPO-derivatives, or interleukin-11) Chemotherapy No prior low-dose antimetabolites for MDS (e.g., hydroxyurea, azacitidine, or low-dose cytarabine) More than 12 months since prior chemotherapy for another disease* NOTE: *Not MDS or leukemia Endocrine therapy More than 1 month since prior corticosteroids for MDS More than 1 month since prior androgens for MDS Radiotherapy More than 12 months since prior radiotherapy for another disease* NOTE: *Not MDS or leukemia Surgery More than 1 month since prior surgery, including needle biopsy of visceral organs and recovered Bone marrow biopsy allowed More than 2 weeks since prior placement of a subcutaneous or tunneled venous access device (e.g., PortaCath or Hickman's catheter) and adequately healed Other No prior cytotoxic therapy for MDS More than 1 month since prior administration of any of the following medications for MDS: Danazol Retinoids Amifostine Investigational agents No concurrent administration of any of the following medications: Warfarin Heparin Derivatives of heparin Other anticoagulants No concurrent grapefruit or grapefruit juice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pankaj Gupta, MD
Organizational Affiliation
Veterans Affairs Medical Center - Minneapolis
Official's Role
Study Chair
Facility Information:
Facility Name
Tunnell Cancer Center at Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Graham Hospital
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Memorial Hospital
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Eureka Community Hospital
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Evanston Northwestern Healthcare - Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-1781
Country
United States
Facility Name
Galesburg Clinic, PC
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Galesburg Cottage Hospital
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Mason District Hospital
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Hopedale Medical Complex
City
Hopedale
State/Province
Illinois
ZIP/Postal Code
61747
Country
United States
Facility Name
McDonough District Hospital
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
BroMenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Hospital of Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Cancer Treatment Center at Pekin Hospital
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Proctor Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
Illinois Valley Community Hospital
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Perry Memorial Hospital
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Center for Cancer Care at OSF Saint Anthony Medical Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61108
Country
United States
Facility Name
St. Margaret's Hospital
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46815
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
Union Hospital Cancer Program at Union Hospital
City
Elkton MD
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
Lakeland Regional Cancer Care Center - St. Joseph
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Veterans Affairs Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Callahan Cancer Center at Great Plains Regional Medical Center
City
North Platte
State/Province
Nebraska
ZIP/Postal Code
69103
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Methodist Estabrook Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Immanuel Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68122
Country
United States
Facility Name
Alegant Health Cancer Center at Bergan Mercy Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131-2197
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-6805
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper - Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Don Monti Comprehensive Cancer Center at North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Affairs Medical Center - Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Faxton Regional Cancer Center
City
Utica
State/Province
New York
ZIP/Postal Code
13502
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Presbyterian Cancer Center at Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233-3549
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Pardee Memorial Hospital
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
Kinston Medical Specialists
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
Oklahoma University Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cancer Care Associates - Mercy Campus
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224-1791
Country
United States
Facility Name
Rhode Island Hospital Comprehensive Cancer Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Mountainview Medical
City
Berlin
State/Province
Vermont
ZIP/Postal Code
05602
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Gupta P, Miller AA, Owzar K, et al.: Pharmacokinetics of an oral VEGF receptor tyrosine kinase inhibitor (PTK787/ZK222584) in patients with myelodysplastic syndrome (MDS): Cancer and Leukemia Group B study 10105. [Abstract] J Clin Oncol 24 (Suppl 18): A-6573, 355s, 2006.
Results Reference
result
PubMed Identifier
23700288
Citation
Gupta P, Mulkey F, Hasserjian RP, Sanford BL, Vij R, Hurd DD, Odenike OM, Bloomfield CD, Owzar K, Stone RM, Larson RA; Alliance for Clinical Trials in Oncology. A phase II study of the oral VEGF receptor tyrosine kinase inhibitor vatalanib (PTK787/ZK222584) in myelodysplastic syndrome: Cancer and Leukemia Group B study 10105 (Alliance). Invest New Drugs. 2013 Oct;31(5):1311-20. doi: 10.1007/s10637-013-9978-z. Epub 2013 May 23.
Results Reference
result

Learn more about this trial

Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes

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