Study to Evaluate Safety & Tolerability of BMS-906024 in Combination With Chemotherapy & to Define DLTs & MTD of BMS-906024 in Combination With One of the Following Chemotherapy Regimens; Weekly Paclitaxel, 5FU+Irinotecan or Carboplatin+Paclitaxel in Subjects With Advanced / Metastatic Solid Tumors

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653470
• Other study ID #: CA216-003
• Secondary ID: 2012-003232-23
• Status: Completed
• Phase: Phase 1
• Start date: October 12, 2012
• Est. completion date: May 8, 2017

Study information

• Verified date: January 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

DLTs = dose-limiting toxicities

MTD = Maximum tolerated dose

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: May 8, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Subjects with advanced or metastatic solid tumors for whom a chemotherapy regimen is considered appropriate

• Subjects with non-small cell lung cancer and triple-negative breast cancer 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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Paclitaxel

• 5-Fluorouracil (5FU)

• Carboplatin

• Leucovorin

• Irinotecan

• Paclitaxel

• BMS-906024

Locations

Country	Name	City	State
Belgium	Local Institution	Brussels
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Ottawa	Quebec
Canada	Local Institution	Toronto	Ontario
United States	Usc/Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Belgium,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Up to 30 days after the last dose of study medication
Secondary	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	Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks	16 time points up to first 3 cycles
Secondary	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	Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks	16 time points up to first 3 cycles
Secondary	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	Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks	16 time points up to first 3 cycles
Secondary	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)	Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks	16 time points up to first 3 cycles
Secondary	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	Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks	16 time points up to first 3 cycles
Secondary	Steady-state infusion concentration (Css) of 5-Fluorouracil (5-FU)	Duration of first 3 cycles for Arm A: 10 weeks; Arm B: 6 weeks; Arm C: 9 weeks	16 time points up to first 3 cycles
Secondary	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		Every 6 weeks until confirmed disease progression, death or discontinuation for other reasons (whichever comes first) [Approximately 24 months]
Secondary	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		Baseline (study days -28 to -1)

External Links

•   BMS Clinical Trial Information
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