Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors

Solid Tumors Clinical Trial

Official title:

Phase I Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018966
• Other study ID #: CA163-029
• Status: Completed
• Phase: Phase 1
• First received: November 24, 2009
• Last updated: January 27, 2017
• Start date: April 2004
• Est. completion date: April 2005

Study information

• Verified date: January 2017
• Source: R-Pharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• 20 years or older

• Histologically or cytologically confirmed diagnosis of adenocarcinoma Solid tumors

Exclusion Criteria:

• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of =2

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• Ixabepilone
Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
R-Pharm

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the maximum tolerated dose (MTD), and a recommended Phase II dose of Ixabepilone when administered every three weeks by assessing status of treatment, dose intensity, and dose-limiting toxicities (DLT)		3-week treatment cycles until unacceptable toxicity
Secondary	To evaluate safety by assessing adverse events. Toxicity will be evaluated according to the Common Toxicity Criteria Version 3.0 (CTC). Response will be evaluated according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria		3-week treatment cycles
Secondary	To evaluate the plasma pharmacokinetics of Ixabepilone according to the following parameters: Cmax, AUC(INF), Tmax, t1/2, MRT(INF), Vss, Cltot		Cycle 1 (first 3 weeks of study therapy)
Secondary	To describe any preliminary evidence of anti-tumor activity (response), assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST)		3-week treatment cycles until unacceptable toxicity

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form