Phase I Combination w/ Epirubicin

NCT00322374 | Completed Phase 1 Results

• 2 other identifiers: CA163-104Eudract No: 2005-004864-22
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 2

Brief Summary

Tumor response information was obtained for all participants who received at least 2 cycles of study drug, underwent requisite baseline and on-treatment disease assessments and had at least one post-treatment assessment. Tumor response assessment in evaluable participants was done according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

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

  DLT: any of the following considered related to ixabepilone, epirubicin or combination occurring in Cycle 1: Absolute neutrophil count \<500 cells/mm\^3 for ≥7 consecutive days or febrile neutropenia of any duration;Grade(Gr)4 thrombocytopenia \<25,000 cells/mm\^3 or Gr3 w/bleeding requiring platelet transfusion;Any other drug-related Gr3/4 non-hematologic toxicity except Gr3 injection site reaction, fatigue, transient arthralgia/myalgia;Delayed recovery to Gr≤1 or baseline (except for alopecia) from toxicity related to treatment w/ ixabepilone + epirubicin delaying initiation of next cycle ≥3 wks

  From Baseline to the end of Cycle 1 (Day 21)

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

  The MTD was the highest dose in which 0/6 or 1/6 participants experienced DLT with at least 2 out of no more than 6 participants experiencing DLT at the next higher dose level. The RP2D was based on the MTD and the assessment of any relevant chronic toxicity. To obtain further confidence in the RP2D, a total maximum of 30 evaluable participants were enrolled at the MTD.

  Day 21 of Cycle 1

Secondary Outcomes (14)

• Number of Participants With Death, Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3/4 AEs, or AEs Leading to Discontinuation

  Evaluated continuously on study from Baseline to ≤30 days after the last dose of study drug.

• Maximum Plasma Concentration (Cmax) of Single-dose Ixabepilone

  From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.

• Area Under the Curve, Extrapolated to Infinity (AUC[INF]) of Single-dose Ixabepilone

  From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.

• Terminal Half-life (T-Half) of Single-dose Ixabepilone

  From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.

• Clearance (CLT) of Single-dose Ixabepilone

  From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.

Study Arms (3)

25 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin

EXPERIMENTAL

Participants received 25 mg/m\^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m\^2 epirubicin every 21 days.

Drug: Ixabepilone; Drug: Epirubicin

30 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin

EXPERIMENTAL

Participants received 30 mg/m\^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m\^2 epirubicin every 21 days.

Drug: Ixabepilone; Drug: Epirubicin

35 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin

EXPERIMENTAL

Participants received 35 mg/m\^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m\^2 epirubicin every 21 days.

Drug: Ixabepilone; Drug: Epirubicin

Interventions

Ixabepilone DRUG

Infusion, intravenous (IV), Cycle = 21 days. Dose escalation study.

Also known as: IXEMPRA®, BMS-247550, Epothilone

25 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin; 30 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin; 35 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin

Epirubicin DRUG

Infusion, intravenous (IV): 75 mg/m\^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m².

25 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin; 30 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin; 35 mg/m^2 Ixabepilone plus 75 mg/m^2 Epirubicin

Eligibility Criteria

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

You may qualify if:

• Women ≥18 years
• Histologically or cytologically confirmed diagnosis of metastatic breast cancer
• Measurable or nonmeasurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST)

You may not qualify if:

• Number of prior chemotherapy lines of treatment in the metastatic setting ≥2

Sponsors & Collaborators

• R-Pharm: lead

Study Sites (2)

Local Institution

Toulouse, 31052, France

Location

Local Institution

Milan, 20133, Italy

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ixabepilone; Epothilones; Epirubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: BMS 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2006
• First Posted: May 5, 2006
• Study Start: August 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: March 10, 2016
• Results First Posted: August 10, 2010

Record last verified: 2016-02

Locations

FR (1); IT (1)