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

Inclusion Criteria

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