Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Women With Advanced Breast Cancer

NCT00452673 | Completed Phase 1 Results

• 2 other identifiers: CA180-004EUDRACT: 2006-006973-26
• Study Type: interventional
• Target: 52
• Locations: 3 countries
• Sites: 7

Brief Summary

The purpose of this study is to learn about the safety and efficacy of Dasatinib in combination with Capecitabine for patients with advanced breast cancer, and who have received treatment with a taxane and an anthracycline

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population

  Safety was assessed from first dose of study drug through at least 30 days after the last dose, until resolution of drug-related toxicity or when toxicity was deemed irreversible, whichever was longer. An adverse event (AE) was considered a dose limiting toxicity (DLT) if it occurred in the first 21 days and was at least possibly related to study drugs and were: Clinically-evident toxicity of Grade \>= 3, or of Grade 2 which required interruption of treatment for \>= 7 days (consecutive or non-consecutive); non-hematologic abnormal laboratory value of Grade \>= 3, or hematologic toxicity of Grade 4, which persisted 7 days; any grade toxicity which in the judgment of the investigator required a dose reduction or removal from further study therapy.

  Day 1 to 30 days post last dose

Secondary Outcomes (5)

• Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population

  Day 1 up to 30 days post last dose

• Number of Participants With Overall Response to Tumor - Efficacy Evaluable Population

  Day 1 to 30 days post last dose

• Objective Response Rate (ORR) and Disease Control Rate - Efficacy Evaluable Population

  Day 1 up to 30 days post last dose

• Number of Participants On-Study With Grade 3 - 4 Hematology Laboratory Test Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population

  Day 1 up to 30 days post last dose

• Number of Participants On-study With Grade 3 - 4 Chemistry Laboratory Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population

  Day 1 to 30 days post last dose

Study Arms (4)

50 mg BID dasatinib + 825 mg/m^2 BID capecitabine

EXPERIMENTAL

Twice a day (BID) for 2 weeks of a 3-week cycle

Drug: Dasatinib; Drug: Capecitabine

70 mg BID dasatinib + 825 mg/m^2 BID capecitabine

EXPERIMENTAL

BID for 2 weeks of a 3-week cycle

Drug: Dasatinib; Drug: Capecitabine

70 mg BID dasatinib + 1000 mg/m^2 BID capecitabine

EXPERIMENTAL

BID for 2 weeks of a 3-week cycle

Drug: Dasatinib; Drug: Capecitabine

100 mg QD dasatinib + 1000 mg/m^2 BID capecitabine

EXPERIMENTAL

2 weeks of a 3-week cycle

Drug: Dasatinib; Drug: Capecitabine

Interventions

Dasatinib DRUG

Tablets, Oral, 50 mg or 70 mg twice a day (BID), 100 mg once per day (QD). Treatment may continue until disease progression

Also known as: BMS-354825

100 mg QD dasatinib + 1000 mg/m^2 BID capecitabine; 50 mg BID dasatinib + 825 mg/m^2 BID capecitabine; 70 mg BID dasatinib + 1000 mg/m^2 BID capecitabine; 70 mg BID dasatinib + 825 mg/m^2 BID capecitabine

Capecitabine DRUG

Tablets, Oral, 660 - 1250 mg/m\^2 twice a day (BID). Treatment may continue until disease progression.

Also known as: Spycel®

100 mg QD dasatinib + 1000 mg/m^2 BID capecitabine; 50 mg BID dasatinib + 825 mg/m^2 BID capecitabine; 70 mg BID dasatinib + 1000 mg/m^2 BID capecitabine; 70 mg BID dasatinib + 825 mg/m^2 BID capecitabine

Eligibility Criteria

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

You may qualify if:

• Female with advanced breast cancer previously treated with a taxane and an anthracycline
• No pleural or pericardial effusion
• Not receiving anticoagulants

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (7)

City Of Hope National Medical Center

Duarte, California, 91010-3000, United States

Location

Northwestern University Feinberg School Of Medicine

Chicago, Illinois, 60611, United States

Location

New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

Local Institution

Rozzano, Milano, 20089, Italy

Location

Local Institution

Barcelona, 08035, Spain

Location

Local Institution

Seville, 41013, Spain

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Interventions

Dasatinib; Capecitabine

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 27, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 24, 2015
• Results First Posted: December 6, 2013

Record last verified: 2015-03

Locations

US (4); IT (1); ES (2)