Phase 1 Trial of Oral Ixabepilone

NCT00632424 | Terminated Phase 1 Results

• 1 other identifier: CA163-149
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

This Phase 1 study of oral ixabepilone given every 6 hours for 3 doses on Day 1, every 21 days, was a dose-finding study designed to determine the maximum tolerated dose (MTD) and safety of this dosing schedule in participants with advanced cancer

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Number of Participants With a Dose-Limiting Toxicity (DLT)

  DLT: any of the following, considered related to ixabepilone, occurring in Cycle 1: Absolute neutrophil count (ANC) \<500 cells/mm\^3 for ≥5 consecutive days or febrile neutropenia of any duration; Grade(Gr)4 thrombocytopenia \<25,000 cells/mm\^3 or Gr3 with bleeding requiring platelet transfusion; Gr3/4 nausea, vomiting, or diarrhea despite use of adequate intervention, fatigue, any other clinically significant drug-related ≥Gr 3 non-hematologic toxicity, delayed recovery (to Gr ≤1 or baseline, except alopecia) from toxicity which delays initiation of Cycle 2 by ≥3 weeks.

  During Cycle 1 (Day 0 through Day 21)

• Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)

  The MTD was defined as the maximum dose which could be given to 6 participants such that not more than 1 participant experienced a DLT (or fewer than one-third if there were more than 6 treated participants) with at least 2 participants experiencing a DLT at the next higher dose level. The R2PD was to be based on the MTD and the assessment of any relevant chronic toxicities.

  At the end of Cycle 1 (21 days).

Secondary Outcomes (7)

• Number of Participants With Adverse Event (AE), AE Leading to Discontinuation, Treatment-related AE, Treatment-related AE Leading to Discontinuation (DC), Most Common Treatment-Related Nonhematologic AE (>25%), Serious AE (SAE), or Treatment-related SAE

  From first study drug administration through 30 days post dose

• Number of Participants With Most Common Treatment-Related Nonhematologic AEs (>25%)

  From first study drug administration through 30 days post dose

• Number of Participants With Hematology Laboratory Abnormalities

  From first study drug administration through 30 days post dose

• Number Of Participants With Liver Function and Renal Laboratory Abnormalities

  From first study drug administration through 30 days post dose

• Maximum QTc Interval on Day 1 and Maximum Change From Baseline for QTc Interval

  Baseline (Day -1) and Day 1

Study Arms (1)

1

EXPERIMENTAL

Drug: Ixabepilone (oral formulation)

Interventions

Ixabepilone (oral formulation) DRUG

Capsules, Oral, Dose escalating (Phase 1), 3 doses on 1 day every 3 weeks, until disease progression or unacceptable toxicity

Also known as: IXEMPRA, BMS-247550

1

Eligibility Criteria

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

You may qualify if:

• Males and females, 18 or older
• Histologically or cytologically confirmed diagnosis of solid tumor malignancy
• Measurable or non-measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
• Karnofsky Performance Status (KPS) of 70-100
• Recovered from toxicities resulting from previous therapies

You may not qualify if:

• More than 3 prior cytotoxic regimens in the metastatic setting
• Current or recent gastrointestinal (GI) disease that would impact the absorption of study drug
• Inability to swallow whole capsules
• Inadequate hepatic and renal function
• Function exposure to any epothilone

Sponsors & Collaborators

• R-Pharm: lead

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Interventions

ixabepilone; Dosage Forms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Limitations and Caveats

The MTD of oral ixabepilone at the scheduled doses used in this study was not determined due to early study discontinuation.

Results Point of Contact

• Title: Name/Official Title: BMS Study Director
• Organization: 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 10, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 10, 2016
• Results First Posted: December 2, 2010

Record last verified: 2016-02

Locations

US (2)