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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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer

Intervention: Paclitaxel (Drug); 5-Fluorouracil (5FU) (Drug); Carboplatin (Drug); Leucovorin (Drug); Irinotecan (Drug); Paclitaxel (Drug); BMS-906024 (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:, Email: Clinical.Trials@bms.com

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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)

Secondary outcome:

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

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 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

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)

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

Steady-state infusion concentration (Css) of 5-Fluorouracil (5-FU)

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

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

Detailed description: DLTs = dose-limiting toxicities MTD = Maximum tolerated dose

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:, Email: Clinical.Trials@bms.com

Local Institution, Brussels 1000, Belgium; Recruiting
Site 0005

Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada; Recruiting
Siu-Chung Chu, Site 0003, Phone: 780-577-8137

Usc/Norris Comprehensive Cancer Center, Los Angeles, California 90033, United States; Recruiting
Anthony El-Khoueiry, Site 001, Phone: 323-865-3957

Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada; Recruiting
Lillian L Siu, Site 0002, Phone: 416-946-4501, Ext: 3450

The Ottawa Hospital Cancer Centre, Ottawa, Quebec K1H 8L6, Canada; Recruiting
Glenwood Goss, Site 0004, Phone: 613-737-7700, Ext: 70300

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: October 2012
Last updated: August 6, 2015

Page last updated: August 20, 2015

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