Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.

NCT00162136 | Completed Phase 1 Results

• 1 other identifier: CA163-085
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.

Conditions

Solid Malignancies

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose Limiting Toxicities at Dose Level

  Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for \>14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C; thrombocytopenia \<25,000 cells/mm3 or bleeding requiring a platelet transfusion.

  Measures taken at Cycle 01 (21-day cycle)

Secondary Outcomes (4)

• Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation

  From time of screening through post study follow-up at a maximum of 21 9-day cycles. Toxicity assessments occured at least every 4 weeks until all study drug related toxicities.

• Hematology Results - Worst On-Study Grade

  Baseline (within 2 weeks of dosing), weekly, and within 72 hours prior to each subsequent 21-day cycle. If CTC Grade 4 hematologic toxicity is observed, complete blood count plus differential and platelets repeated every 3 days until resolution.

• Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level

  through 72 hours after start of infusion

• Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)

  At Baseline (up to 2 weeks prior to starting therapy), after every 2nd cycle, and at post study follow-upn after a maximum of 9 cycles.

Study Arms (1)

A1

EXPERIMENTAL

Drug: Ixabepilone

Interventions

Ixabepilone DRUG

Intravenous (IV) Infusion; 10, 20, 30, 35, 40 \& 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles

Also known as: IXEMPRA®

A1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed diagnosis of a primary solid tumor
• measurable or non-measurable disease
• progressive disease
• men and women greater or equal to 18 years of age.

You may not qualify if:

• women of child bearing potential who are not using birth control
• women who are pregnant or breast feeding
• women with a positive pregnancy test on enrollment
• patients with brain metastasis
• prior treatment with Ixabepilone
• known history of human immunodeficiency virus (HIV)

Sponsors & Collaborators

• R-Pharm: lead

Study Sites (3)

University Of Maryland

Baltimore, Maryland, 21201, United States

Location

The Cancer Institute Of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

ixabepilone

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 13, 2005
• Study Start: September 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: November 2, 2020
• Results First Posted: January 27, 2010

Record last verified: 2016-02

Locations

US (3)