Clinical trial · Interventional
Combination Trial of Patupilone and Carboplatin in Adult Patients With Advanced Solid Tumors
A Phase Ib, Multicenter, Open-label, Dose-finding Study of Patupilone Administered Intravenously Every 3 Weeks in Combination With Carboplatin AUC 6 in Adult Patients With Advanced Solid Tumors
NCT00426582CI-TRIAL-00048727completedPhase 1ClinicalTrials.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 study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone combined with carboplatin in adult patients with advanced solid tumors who progressed despite standard therapy or for whom no standard therapy exists or who might benefit from treatment with carboplatin
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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patupilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patupilone only
- description
- Cycle 1 patupilone alone Cycle 2 and onward patupilone and carboplatin
- interventionNames
- Drug: Patupilone
- type
- ACTIVE_COMPARATOR
- label
- Carboplatin alone
- description
- Cycle 1 Carboplatin alone Cycle 2 and onward patuilone and carboplatin
- interventionNames
- Drug: Patupilone
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6)
- timeFrame
- Every 3 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Histologically or cytologically confirmed advanced solid tumors who have progressed despite standard therapy, or for whom no standard therapy exists, or who might benefit from treatment with carboplatin * A minimum of 4 weeks since the last treatment with chemotherapy * WHO Performance Status 0 (able to carry out all normal activity without restriction) or 1 (restricted in physically strenuous activity but ambulatory and able to carry out work) * Age ≥ 18 * Adequate hematological parameters * No major impairment of renal or hepatic function * Written informed consent obtained Exclusion criteria: * Major surgery less than 4 weeks prior to study entry and/or not fully recovered from surgery * Chemotherapy or investigational compound less than 4 weeks prior to study entry, or planned while participating in the study * Prior administration of an epothilone * Hypersensitivity to carboplatin. Patients resistant to carboplatin are not recommended to enter the trial * Radiotherapy (RT) less than 4 weeks prior to study entry (except for palliative therapy of distant metastases), or planned RT while participating in the study * Diarrhea within 7 days prior to start of treatment. Unresolved bowel obstruction * Peripheral neuropathy \> Grade 1 (mild) * Symptomatic brain metastases * Colostomy Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.