A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
- Registration Number
- NCT00831636
- Lead Sponsor
- Clavis Pharma
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 28
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open label CP-4055 CP-4055 Phase I: Dose escalation Phase II: Fixed dose
- Primary Outcome Measures
Name Time Method 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 August 2009/June 2010 Phase II: Determine the antitumour activity of CP-4055 August 2009/June 2010
- Secondary Outcome Measures
Name Time Method Explore the time to progression (TTP) August 2009/June 2010 Investigate the duration of tumour response August 2009/June 2010 Determine the nature and degree of toxicity of CP-4055 in this patient population August 2009/June 2010 Determine pharmacokinetic (PK) parameters August 2009/June 2010
Trial Locations
- Locations (5)
Medical Oncology, Fatebenefratelli Hospital, Isola Tiberina
🇮🇹Rome, Italy
Department of Oncology, Catholic University of the Sacred Heart
🇮🇹Rome, Italy
U.Z. Gasthuisberg, Gynecologic Oncology, Herestraat 49
🇧🇪Leuven, Belgium
Medical Oncology C, National Cancer Institute, Centro di Riferimento Oncologico
🇮🇹Aviano (PN), Italy
Medical Oncology B, National Cancer Institute, Via Mariano Semmola
🇮🇹Naples, Italy