Clinical trial · Interventional
A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
NCT00831636CI-TRIAL-00012061completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CP-4055 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Open label CP-4055
- description
- Phase I: Dose escalation Phase II: Fixed dose
- interventionNames
- Drug: CP-4055
Primary outcomes (2)
- measure
- 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
- timeFrame
- August 2009/June 2010
- measure
- Phase II: Determine the antitumour activity of CP-4055
- timeFrame
- August 2009/June 2010
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.