Advanced Solid Tumors
Conditions
Keywords
Cancer, maximum tolerated dose, dose-limiting toxicity, patupilone, carboplatin, pharmacokinetics
Brief summary
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
Interventions
DRUGPatupilone
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6) | Every 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations | Every 6 weeks |
| Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors) | Every 6 weeks |
| Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response | Every 6 weeks |
| Pharmacokinetic profile of patupilone combined with carboplatin | First 6 weeks (cycle 1 & 2 only) |
| Relationship between pharmacokinetics and clinical outcome | Every 6 weeks during cycle 1 & cycle 2 |
Countries
United States
Outcome results
None listed