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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2007-003323-20-BE |
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Date of registration:
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27/02/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase I/II Study of CP-4055 in Patients with Platinum Resistant Ovarian Cancer - CP4055-204
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Scientific title:
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A Phase I/II Study of CP-4055 in Patients with Platinum Resistant Ovarian Cancer - CP4055-204 |
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Date of first enrolment:
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30/05/2008 |
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Target sample size:
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50 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003323-20 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Belgium
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Histologically or cytologically documented advanced (stage III and IV according to the FIGO and AJCC systems) epithelial ovarian cancer measurable with CT and/or MRI, excluding mixed mullerian tumours (MMT) (carcinosarcomas)
2. Received prior chemotherapy regimen(s) for ovarian cancer, at least one being a platinum based therapy (PBT); i.e., carboplatin, cisplatin, or another organoplatinum compound. The last dose of prior chemotherapy should have been given at least 6 weeks before start of CP-4055 treatment
3. Evidence of platinum resistant or refractory disease. Resistant defined as progression according to RECIST or CA-125 within 6 months after completion of PBT. Refractory defined as progression during PBT or no disease free period during PBT. See Appendix B1 and Appendix B2
4. ECOG Performance Status 0 – 1
5. Age 18 years or more
6. Life expectancy > 3 months
7. Signed informed consent (IC)
8. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded.
9. Women of child-bearing potential must not become pregnant while participating in the study
10. Adequate haematological and biological functions:
• Bone marrow function:
a. Neutrophils = 1.5 x 10 in 9 /L
b. Platelets = 100 x 10 in 9 /L
c. Hb = 9 g/dL
• Hepatic function:
a. AST (SGOT) / ALT (SGPT) = 2.5 times institutional upper limit of normal (ULN). If liver metastases = 5 times institutional ULN
b. Serum bilirubin = 1.5 times institutional ULN
• Renal function:
Creatinine = 1.5 times institutional ULN
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Patients with mixed mullerian tumours (MMT) (carcinosarcomas)
2. Known brain metastases
3. Another known active cancer within the last 5 years
4. Radiotherapy to more than 30 % of bone marrow
5. Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
6. Concomitant treatment with a non-permitted medication:
• Alternative medicine, i.e., any of various systems of healing or treating disease (such as non-prescriptive drugs, herbal medicine, homeopathy)
• High doses of vitamins
7. 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
8. Any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
9. Any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance
10. Pregnancy or breastfeeding
11. Known positive status for HIV and/or hepatitis B or C
12. Drug and/or alcohol abuse
13. Any reason why, in the investigator’s opinion, the patient should not participate
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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A phase I/II clinical study of CP4055 in patients with platinum resistant ovarian cancer
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Intervention(s)
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Product Name: CP-4055 for infusion
Product Code: CP-4055
Pharmaceutical Form: Concentrate for solution for infusion
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Primary Outcome(s)
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Secondary Objective: - Determine pharmacokinetic parameters
- Explore the time to progression
- Investigate the duration of tumor response
- Determine the nature and degree of toxicity of CP-4055 in this patient population
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Main Objective: Phase I: To determine the recommended dose of CP-4055 when given five consecutive days twice in a 4 week schedule, D1-5 and D8(+2)-12 (+2) q4W
Phase II: To determine the antitumour activity of CP-4055 in patients with platinum resistant ovarian cancer according to Response Criteria in Solid Tumors RECIST and Gynecologic Cancet Intergroup (CGIG) CA-125 measurements
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Primary end point(s): The primary endpoint is the confirmed RR. The RR is defined either as PR and/or CR according to RECIST or as change in CA 125 level (at least a 50 % reduction in CA 125 levels from the pre-treatment sample). This RR will be estimated and a 95 % confidence interval calculated.
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Secondary ID(s)
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CP4055-204
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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