A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CP-4055
CP-4055
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring CP-4055, Cancer, Metastatic, Solid tumors, advanced ovarian cancer, stage III and IV ovarian cancer, advanced epithelian ovarian cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically documented advanced epithelial ovarian cancer measurable with CT and/or MRI
- Received prior chemotherapy regimen(s) for ovarian cancer, at least one being a platinum based therapy (PBT)
- Evidence of platinum resistant or refractory disease
- ECOG Performance Status 0 - 1
- Life expectancy > 3 months
- Signed informed consent (IC)
- Women of child-bearing potential must have a negative serum or urine pregnancy test. Nursing patients are excluded.
- Women of child-bearing potential must not become pregnant while participating in the study
- Adequate haematological and biological functions
Exclusion Criteria:
- Patients with mixed mullerian tumours (MMT) (carcinosarcomas)
- Known brain metastases
- Another known active cancer within the last 5 years
- Radiotherapy to more than 30 % of bone marrow
- Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
- Concomitant treatment with a non-permitted medication
- A history of allergic reactions or sensitivity attributed to compounds of similar or biological composition to CP-4055, i.e., ara-C and/or egg
- Any serious concomitant systemic disorders incompatible with the clinical study
- Any significant CNS or psychiatric disorder(s) that would hamper the patient's compliance
- Pregnancy or breastfeeding
- Known positive status for HIV and/or hepatitis B or C
- Drug and/or alcohol abuse
- Any reason why, in the investigator's opinion, the patient should not participate
Sites / Locations
- U.Z. Gasthuisberg, Gynecologic Oncology, Herestraat 49
- Medical Oncology C, National Cancer Institute, Centro di Riferimento Oncologico
- Medical Oncology B, National Cancer Institute, Via Mariano Semmola
- Department of Oncology, Catholic University of the Sacred Heart
- Medical Oncology, Fatebenefratelli Hospital, Isola Tiberina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open label CP-4055
Arm Description
Phase I: Dose escalation Phase II: Fixed dose
Outcomes
Primary Outcome Measures
Phase I: Determine recommended dose for phase II studies of CP-4055 when given five consecutive days twice in a 4 week schedule, D1-5 and D8(+2)-12(+2) q4w
Phase II: Determine the antitumour activity of CP-4055
Secondary Outcome Measures
Determine pharmacokinetic (PK) parameters
Explore the time to progression (TTP)
Investigate the duration of tumour response
Determine the nature and degree of toxicity of CP-4055 in this patient population
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00831636
Brief Title
A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
Official Title
A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clavis Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is non randomised, open label, dose finding, efficacy and safety study, enrolling patients with advanced (stage III and IV) ovarian cancer It will be conducted in two successive phases. Phase II has a two-step design
Detailed Description
Phase I
Three eligible patients will be enrolled at each dose level (DL), according to standard dose escalation decision rules
Patients will receive CP-4055 at increasing DLs until the maximum tolerated dose and the recommended dose (RD) have been established
Phase II
Step 1 (The patient inclusion may stop after this step):
Patients will be enrolled at the RD until there are maximum 16 evaluable patients at this DL
Step 2:
Depending on the response rate at step 1, up to 26 patients will be included and treated at step 2
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
CP-4055, Cancer, Metastatic, Solid tumors, advanced ovarian cancer, stage III and IV ovarian cancer, advanced epithelian ovarian cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open label CP-4055
Arm Type
Experimental
Arm Description
Phase I: Dose escalation Phase II: Fixed dose
Intervention Type
Drug
Intervention Name(s)
CP-4055
Intervention Description
D1-5 and D8(+2)-12(+2) q4w
Intervention Type
Drug
Intervention Name(s)
CP-4055
Intervention Description
IV administration day 1-5 and day 8-12 in a 4 week schedule
Primary Outcome Measure Information:
Title
Phase I: Determine recommended dose for phase II studies of CP-4055 when given five consecutive days twice in a 4 week schedule, D1-5 and D8(+2)-12(+2) q4w
Time Frame
August 2009/June 2010
Title
Phase II: Determine the antitumour activity of CP-4055
Time Frame
August 2009/June 2010
Secondary Outcome Measure Information:
Title
Determine pharmacokinetic (PK) parameters
Time Frame
August 2009/June 2010
Title
Explore the time to progression (TTP)
Time Frame
August 2009/June 2010
Title
Investigate the duration of tumour response
Time Frame
August 2009/June 2010
Title
Determine the nature and degree of toxicity of CP-4055 in this patient population
Time Frame
August 2009/June 2010
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically documented advanced epithelial ovarian cancer measurable with CT and/or MRI
Received prior chemotherapy regimen(s) for ovarian cancer, at least one being a platinum based therapy (PBT)
Evidence of platinum resistant or refractory disease
ECOG Performance Status 0 - 1
Life expectancy > 3 months
Signed informed consent (IC)
Women of child-bearing potential must have a negative serum or urine pregnancy test. Nursing patients are excluded.
Women of child-bearing potential must not become pregnant while participating in the study
Adequate haematological and biological functions
Exclusion Criteria:
Patients with mixed mullerian tumours (MMT) (carcinosarcomas)
Known brain metastases
Another known active cancer within the last 5 years
Radiotherapy to more than 30 % of bone marrow
Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
Concomitant treatment with a non-permitted medication
A history of allergic reactions or sensitivity attributed to compounds of similar or biological composition to CP-4055, i.e., ara-C and/or egg
Any serious concomitant systemic disorders incompatible with the clinical study
Any significant CNS or psychiatric disorder(s) that would hamper the patient's compliance
Pregnancy or breastfeeding
Known positive status for HIV and/or hepatitis B or C
Drug and/or alcohol abuse
Any reason why, in the investigator's opinion, the patient should not participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandro Pignata, MD
Organizational Affiliation
Medical Oncology B, National Cancer Institute, Via Mariano Semmola, IT-80131 Naples, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.Z. Gasthuisberg, Gynecologic Oncology, Herestraat 49
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Medical Oncology C, National Cancer Institute, Centro di Riferimento Oncologico
City
Aviano (PN)
Country
Italy
Facility Name
Medical Oncology B, National Cancer Institute, Via Mariano Semmola
City
Naples
ZIP/Postal Code
IT-80131
Country
Italy
Facility Name
Department of Oncology, Catholic University of the Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Medical Oncology, Fatebenefratelli Hospital, Isola Tiberina
City
Rome
Country
Italy
12. IPD Sharing Statement
Links:
URL
http://www.clavispharma.com/
Description
Clavis Pharma Home Page
Learn more about this trial
A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
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