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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma, Non-Small-Cell Lung

Intervention: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL (Drug); Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.

Clinical Details

Official title: A Phase I Study of Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer as First-line Treatment

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Participants With Dose-limiting Toxicity (DLT)

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2

Secondary outcome:

Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation

Number of Participants With Grade 3 or Greater Treatment-related AEs

Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade

Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade

Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade

Number of Participants With Abnormalities in Blood Pressure and Heart Rate

Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status

Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment

Maximum Observed Plasma Concentration of Ixabepilone

Time of Maximum Observed Plasma Concentration of Ixabepilone

Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone

Volume of Distribution at Steady State of Ixabepilone

Total Body Clearance of Ixabepilone

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Local Institution, Chuo-Ku, Tokyo 104-0045, Japan
Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: June 2008
Last updated: March 15, 2011

Page last updated: August 23, 2015

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