Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00683904
• Date of registration: 22/05/2008
• Primary sponsor: Bristol-Myers Squibb
• Public title: Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer
• Scientific title: A Phase I Study of Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer as First-line Treatment
• Date of first enrolment: June 2008
• Target sample size: 12
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00683904
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Japan

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age =20 years

- Histologic or cytologic diagnosis of advanced non-small cell lung cancer (NSCLC)

- Advanced NSCLC, defined as stage IIIB (without indications for radiotherapy), stage
IV, or recurrent

- No prior chemotherapy-containing regimens for the treatment of NSCLC

- Eastern Cooperative Oncology Group performance status of 0-1

- Life expectancy of at least 12 weeks

- Accessible for treatment and follow up; patients who could be hospitalized for first
15 days of Cycle 1

- Adequate recovery from previous systemic therapy (at least 3 weeks for surgery or
radiation therapy)

Exclusion Criteria:

- Women of childbearing potential (WOCBP) unwilling or unable to use an acceptable
method to avoid pregnancy for study period and for up to 4 weeks after last dose of
study drug

- Women pregnant or breast feeding

- Women with a positive pregnancy test result on enrollment or prior to study drug
administration

- Sexually active fertile men not using effective birth control for the entire study
period and for up to 3 months after the last dose of study drug if their partners are
WOCBP

- Patients with symptomatic or requiring treatment for brain metastases and/or
leptomeningeal metastases

- Prior radiation must not have included =30% of major bone-marrow-containing areas
(pelvis, lumbar spine)

- Common Terminology Criteria (CTC) Grade 2 or greater neuropathy

- Psychiatric or other disorders rendering the patient incapable of complying with
protocol requirements

- Any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in
situ of the cervix (Patients with a history of malignancy but without evidence of
disease for 5 years are eligible)

- Serious uncontrolled medical disorder or active systemic infection that would
impair the ability of the subject to receive protocol therapy.

- Myocardial infarction, unstable angina, or unstable congestive heart failure within 6
months

- Known history of infection with human immunodeficiency virus

- Inadequate bone marrow function

- Inadequate hepatic function

- Inadequate renal function

- Known prior severe hypersensitivity reaction (CTC Grade 2 or greater) to agents
containing Cremophor®EL

- Known severe hypersensitivity reaction to agents containing carboplatin and other
platinum

- Prior treatment with an epothilone and/or with platinum

- History of high-dose chemotherapy with bone marrow transplant or peripheral blood
stem cell support within 2 years

- On treatment with strong Cytochrome P450 3A4 inhibitor

- Current imprisonment

- Compulsorily detention for treatment of psychiatric or physical illness



Age minimum: 20 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Carcinoma, Non-Small-Cell Lung

Intervention(s)

Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL

Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL

Primary Outcome(s)

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2 [Time Frame: Days 1 through 21 (Cycle 1)]

Number of Participants With Dose-limiting Toxicity (DLT) [Time Frame: Days 1 through 21 (Cycle 1)]

Secondary Outcome(s)

Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone [Time Frame: Days 1 to 8 of Cycle 1 (21 days)]

Maximum Observed Plasma Concentration of Ixabepilone [Time Frame: Days 1 to 8 of Cycle 1 (21 days)]

Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment [Time Frame: Days 1 through 21 (Cycle 1)]

Number of Participants With Abnormalities in Blood Pressure and Heart Rate [Time Frame: At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)]

Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade [Time Frame: At screening and Days 8 and 15 of Cycle 1 (21 days)]

Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade [Time Frame: At screening and Days 8 and 15 of Cycle 1 (21 days)]

Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade [Time Frame: At screening and Days 8 and 15 of Cycle 1 (21 days)]

Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status [Time Frame: At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)]

Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation [Time Frame: Days 1 through 21 (Cycle 1)]

Number of Participants With Grade 3 or Greater Treatment-related AEs [Time Frame: Days 1 through 21 (Cycle 1)]

Time of Maximum Observed Plasma Concentration of Ixabepilone [Time Frame: Days 1 to 8 of Cycle 1 (21 days)]

Total Body Clearance of Ixabepilone [Time Frame: Days 1 to 8 of Cycle 1 (21 days)]

Volume of Distribution at Steady State of Ixabepilone [Time Frame: Days 1 to 8 of Cycle 1 (21 days)]

Secondary ID(s)

CA163-160

Source(s) of Monetary Support

Please refer to primary and secondary sponsors