Phase I Combination Ixabepilone + Cisplatin

R-Pharm

Status and phase: Completed; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Cisplatin; Drug: Ixabepilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00832117

CA163-177

2008-004909-34

Details and patient eligibility

About

The purpose of this study is to determine the highest dose of ixabepilone that can be given safely with cisplatin without causing severe or life-threatening side effects and for some patients with non-small cell lung cancer, the effects (good or bad) on your cancer will also be studied

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Escalation Phase Subjects: Primary solid tumor not curable by local measures such as surgery, radiation

Inclusion Criteria:

• Men and women age ≥ 18

Exclusion:

• More than 2 prior chemotherapy containing regimens for metastatic disease
• No prior exposure to cisplatin or ixabepilone

Expansion Phase Subjects: Advanced Non-small cell lung cancer

Inclusion Criteria:

• Men and women age ≥ 18

Exclusion:

• No prior chemotherapy-containing regimen for metastatic disease
• No prior exposure to cisplatin or ixabepilone

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Escalation and Expansion

Experimental group

Treatment:

Drug: Ixabepilone

Drug: Cisplatin

Drug: Cisplatin

Drug: Ixabepilone