Combination Trial of Patupilone and Carboplatin in Adult Patients With Advanced Solid Tumors

Novartis

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Patupilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00426582

CEPO906A2105

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Patupilone only

Experimental group

Description:

Cycle 1 patupilone alone Cycle 2 and onward patupilone and carboplatin

Treatment:

Drug: Patupilone

Carboplatin alone

Active Comparator group

Description:

Cycle 1 Carboplatin alone Cycle 2 and onward patuilone and carboplatin

Treatment:

Drug: Patupilone