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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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27 July 2020 |
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Main ID: |
EUCTR2004-001457-28-GB |
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Date of registration:
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23/02/2005 |
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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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Phase II open label study of CT-2106 as a single agent in patients with advanced metastatic ovarian cancer who have failed one prior platinum and taxane based regimen
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Scientific title:
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Phase II open label study of CT-2106 as a single agent in patients with advanced metastatic ovarian cancer who have failed one prior platinum and taxane based regimen |
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Date of first enrolment:
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15/10/2007 |
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Target sample size:
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80 |
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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:2004-001457-28 |
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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: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Italy
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Subjects with histologically proven advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen; depending on the response to the prior platinum-taxane chemotherapy, patients will be classified as:
• Platinum-refractory or platinum resistant patients (Group 1): patients with
progressive or stable disease while on 1st line therapy. Patients presenting a response during the 1st line therapy but progressing while still on 1st line therapy will be considered as refractory (platinum-refractory). Patients who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval < 6 months; treatment-free interval is defined as: “time elapsing from the last day of 1st line therapy to the first day of second-line therapy start” (platinumresistant);
• Platinum-sensitive patients (Group 2): Patients who responded (CR or PR) to a 1st
line therapy and subsequently progressed or relapsed after a treatment-free interval = 6 and = 12 months; treatment-free interval is defined as: “time elapsing from the last day of 1st line therapy to the first day of second-line therapy start”
2. The patients must have recovered (= grade 1) from all side effects (except alopecia) of prior therapy (except for diarrhoea, which must be grade 0)
3. Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes
administered concomitantly
4. At least one measurable lesion according to RECIST
5. =18 years old
6. ECOG performance status = 1
7. Life expectancy of more than 3 months as assessed by the investigator;
8. Adequate haematological function: Haemoglobin = 10g/dl, ANC = 2.0 × 109/L, platelets = 100× 109/L
9. Adequate renal and hepatic functions: total bilirubin = 1.25 x ULN, creatinine = 1.25 ×ULN, ASAT and ALAT = 2.5 × ULN, alkaline phosphatases = 2.5 x ULN; in case of
liver metastases, ASAT, ALAT and alkaline phosphatases must be = 5 x ULN
10. Normal coagulation parameters (PT, aPTT, and INR)
11. Subjects must be willing and able to comply with scheduled visits and with management of toxicity
12. Patients with reproductive potential must be able to avoid a pregnancy during the whole study period
13. Signed informed consent prior to beginning protocol specific procedures
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. Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of > 12 months; treatment-free interval is defined as: “time elapsing from the last day of 1st line therapy to the first day of second-line therapy start
2. Past or concurrent history of neoplasm other than ovarian adenocarcinoma, except
curatively treated non melanoma skin cancer or in situ carcinoma of the cervix
3. Pregnant or lactating patients
4. More than one line of chemotherapy for advanced metastatic ovarian cancer
5. Prior treatment with camptothecins
6. Presence or history of CNS metastasis or carcinomatous leptomeningitis
7. Current active infection per investigator assessment
8. Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or
ulcerative colitis
9. Current history of chronic diarrhea = grade 1 (CTCAE version 3)
10. Surgery or radiotherapy = 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, = 2 weeks before the 1st study treatment are allowed
11. Other uncontrolled, serious illness or medical condition, as determined by the
investigator
12. Concomitant (or within 4 weeks before inclusion) administration of any other
experimental drug under investigation
13. Concurrent treatment with any other anti-cancer therapy
14. Known HIV positivity or AIDS-related illness
15. Patients who cannot be regularly followed up for psychological, social, familial or
geographic reasons.
Age minimum:
Age maximum:
Gender:
Female: yes
Male:
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Health Condition(s) or Problem(s) studied
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Advanced metastatic ovarian cancer
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Intervention(s)
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Product Name: CT 2106
Product Code: CT 2106
Pharmaceutical Form: Powder for solution for infusion
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 8-
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Primary Outcome(s)
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Main Objective: To determine the overall response rate (complete plus partial response) of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen.
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Secondary Objective: To determine the quantitative and qualitative toxic effects of CT-2106 treatment.
To estimate the response duration, time to progression, and survival.
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Primary end point(s): The primary efficacy endpoint is the overall objective response rate (complete or partial responses).
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Secondary ID(s)
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CAM 203
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2004-001457-28-IT
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 15/10/2007
Contact:
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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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