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Trial record 3 of 3 for:    BMS-906024
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Study to Evaluate the Safety and Tolerability of BMS-906024 in Combination With Chemotherapy (Weekly Paclitaxel, 5FU Plus Irinotecan (FOLFIRI) or Carboplatin Plus Paclitaxel) in Subjects With Advanced or Metastatic Solid Tumors

This study is currently recruiting participants.
Verified September 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01653470
First received: July 18, 2012
Last updated: March 28, 2013
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in combination with each of the following three chemotherapy regimens: Paclitaxel, 5FU plus Irinotecan (FOLFIRI), or Carboplatin plus Paclitaxel in subjects with advanced or metastatic solid tumors


Condition Intervention Phase
Cancer
 Drug: Paclitaxel
Drug: 5-Fluorouracil (5-FU)
Drug: Carboplatin
Drug: Leucovorin
Drug: Irinotecan
Drug: BMS-906024
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib Ascending Multi-arm, Dose Escalation Study of BMS-906024 Combined With Several Chemotherapy Regimens in Subjects With Advanced or Metastatic Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety assessment based on reports of adverse events and clinical laboratory tests as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum observed plasma concentration (Cmax) of BMS-906024 and BMS-911557 (the active metabolite of BMS-906024), Paclitaxel, Irinotecan, SN-38 (the active metabolite of Irinotecan) and Carboplatin [ Time Frame: 16 time points up to first 3 cycles ] [ Designated as safety issue: No ]
    Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks

  • Trough observed plasma concentration (Cmin) of BMS-906024 and BMS-911557 (the active metabolite of BMS-906024), Paclitaxel, Irinotecan, SN-38 (the active metabolite of Irinotecan) and Carboplatin [ Time Frame: 16 time points up to first 3 cycles ] [ Designated as safety issue: No ]
    Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks

  • Time of maximum observed plasma concentration (Tmax) of BMS-906024 and BMS-911557 (the active metabolite of BMS-906024), Paclitaxel, Irinotecan, SN-38 (the active metabolite of Irinotecan) and Carboplatin [ Time Frame: 16 time points up to first 3 cycles ] [ Designated as safety issue: No ]
    Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks

  • Area under the concentration-time curve during a dosing interval of tau [AUC(TAU)] of BMS-906024 and BMS-911557 (the active metabolite of BMS-906024) [ Time Frame: 16 time points up to first 3 cycles ] [ Designated as safety issue: No ]
    Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks

  • Area under the concentration-time curve from time 0 to the time of the last sample collected in the dosing interval [AUC(0-T)] of Paclitaxel, Irinotecan, SN-38 (the active metabolite of Irinotecan) and Carboplatin [ Time Frame: 16 time points up to first 3 cycles ] [ Designated as safety issue: No ]
    Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks

  • Steady-state infusion concentration (Css) of 5-Fluorouracil (5-FU) [ Time Frame: 16 time points up to first 3 cycles ] [ Designated as safety issue: No ]
    Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks

  • Tumor response [as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria], best overall response (BOR), duration of response, and progression free survival (PFS) will be assessed [ Time Frame: Every 6 weeks until confirmed disease progression, death or discontinuation for other reasons (whichever comes first) [Approximately 24 months] ] [ Designated as safety issue: No ]
  • Gene mutation status of Notch activation markers as well as other genes of interest in relevant indications, in tumor, and gene expression levels of Notch activation markers, such as but not limited to Hes1, Deltex1, in tumor [ Time Frame: Baseline (study days -28 to -1) ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Paclitaxel + BMS-906024
Escalation Phase and Expansion Phase
 Drug: Paclitaxel
Solution for intravenous (IV) administration, IV, 80 mg/m2, Once weekly, Continuously until disease progression or unacceptable toxicity
Other Name: Taxol
Drug: BMS-906024
Solution for intravenous (IV) administration, IV, Escalating doses starting at 2.4 mg, (Expansion - to be determined), Once weekly, Continuously until disease progression or unacceptable toxicity
Other Name: Notch inhibitor
Experimental: Arm B: FOLFIRI + BMS-906024
Escalation Phase and Expansion Phase
 Drug: 5-Fluorouracil (5-FU)
Solution for intravenous (IV) administration, IV, 5FU Bolus: 400 mg/m2, 5FU Infusion: 2400 mg/m2, Once every 2 weeks, Continuously until disease progression or unacceptable toxicity
Other Names:
  • Adrucil
  • Carac
  • Efudix
  • Efudex
  • Fluoroplex
Drug: Leucovorin
Solution for intravenous (IV) administration, IV, 400 mg/m2, Once every 2 weeks, Continuously until disease progression or unacceptable toxicity
Drug: Irinotecan
Solution for intravenous (IV) administration, IV, 180 mg/m2, Once every 2 weeks, Continuously until disease progression or unacceptable toxicity
Other Name: Camptosar
Drug: BMS-906024
Solution for intravenous (IV) administration, IV, Escalating doses starting at 2.4 mg, (Expansion - to be determined), Once weekly, Continuously until disease progression or unacceptable toxicity
Other Name: Notch inhibitor
Experimental: Arm C: Carboplatin/Paclitaxel + BMS-906024
Escalation Phase and Expansion Phase
 Drug: Carboplatin
Solution for intravenous (IV) administration, IV, AUC 6, Once every 3 weeks, Continuously until disease progression or unacceptable toxicity
Other Name: Paraplatin
Drug: Paclitaxel
Solution for intravenous (IV) administration, IV, 200 mg/m2, Once every 3 weeks, Continuously until disease progression or unacceptable toxicity
Other Name: Taxol
Drug: BMS-906024
Solution for intravenous (IV) administration, IV, Escalating doses starting at 2.4 mg, (Expansion - to be determined), Once weekly, Continuously until disease progression or unacceptable toxicity
Other Name: Notch inhibitor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with advanced or metastatic solid tumors for whom a chemotherapy regimen is considered appropriate
  • Subjects with colorectal cancer, non-small cell lung cancer, or triple-negative breast are preferred
  • Biopsy accessible tumor (may use archived tumor samples under certain circumstances)
  • Life expectancy of at least 3 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Measurable disease

Exclusion Criteria:

  • Uncontrolled brain metastases
  • Infection
  • Gastrointestinal (GI) disease with increased risk of diarrhea (e.g. inflammatory bowel disease)
  • Uncontrolled or significant cardiovascular disease
  • Subjects taking medications known to increase risk of Torsades de Pointes)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653470

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
United States, California
Usc Norris Cancer Hospital Laboratory Recruiting
Los Angeles, California, United States, 90033
Contact: Anthony El-Khoueiry, Site 001            
Belgium
Local Institution Recruiting
Bruxelles, Belgium, 1000
Contact: Site 0005            
Canada, Alberta
Local Institution Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 0003            
Canada, Ontario
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 0002            
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01653470     History of Changes
Other Study ID Numbers: CA216-003
Study First Received: July 18, 2012
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Fluorouracil
Irinotecan
Carboplatin
Paclitaxel
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013