NCT01653470

Brief 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P75+ for phase_1 cancer

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_1 cancer

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

October 12, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2017

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2017

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

4.6 years

First QC Date

July 18, 2012

Last Update Submit

January 24, 2020

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

    16 time points up to first 3 cycles

  • 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

    16 time points up to first 3 cycles

  • 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

    16 time points up to first 3 cycles

  • 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)

    16 time points up to first 3 cycles

  • 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

    16 time points up to first 3 cycles

  • +3 more secondary outcomes

Study Arms (5)

Arm A: Paclitaxel + BMS-906024

EXPERIMENTAL

Paclitaxel 80 mg/m2 solution and BMS-906024 4 mg or 6 mg solution intravenously once weekly continuously until disease progression or unacceptable toxicity

Drug: PaclitaxelDrug: BMS-906024

Arm B: FOLFIRI (5FU, Leucovorin, Irinotecan) + BMS-906024

EXPERIMENTAL

5FU Bolus 400 mg/m2, 5FU Infusion 2400 mg/m2, Irinotecan 180 mg/m2 solution, Leucovorin 400 mg/m2 solution intravenously once every 2 weeks and BMS- 906024 4 mg or 6 mg solution intravenously once weekly continuously until disease progression or unacceptable toxicity

Drug: 5-Fluorouracil (5FU)Drug: LeucovorinDrug: IrinotecanDrug: BMS-906024

Arm C: Carboplatin/Paclitaxel + BMS-906024

EXPERIMENTAL

Carboplatin AUC 6 / Paclitaxel 200 mg/m2 solution once every 3 weeks and BMS-906024 4 mg or 6 mg solution once weekly intravenously continuously until disease progression or unacceptable toxicity

Drug: CarboplatinDrug: PaclitaxelDrug: BMS-906024

Arm D: Paclitaxel + BMS-906024

EXPERIMENTAL

Paclitaxel 80 mg/m2 solution once weekly and BMS-906024 4 mg or 6 mg solution once every 2 weeks intravenously continuously until disease progression or unacceptable toxicity

Drug: PaclitaxelDrug: BMS-906024

Arm F: Carboplatin/Paclitaxcel and BMS-906024

EXPERIMENTAL

Carboplatin AUC 6 / Paclitaxel 200 mg/m2 solution once every 3 weeks and BMS-906024 4 mg or 6 mg solution once every 3 weeks intravenously continuously until disease progression or unacceptable toxicity

Drug: CarboplatinDrug: PaclitaxelDrug: BMS-906024

Interventions

PaclitaxelDRUG
Also known as: Taxol
Arm A: Paclitaxel + BMS-906024
5-Fluorouracil (5FU)DRUG
Also known as: Adrucil, Carac, Efudix, Efudex, Fluoroplex
Arm B: FOLFIRI (5FU, Leucovorin, Irinotecan) + BMS-906024
CarboplatinDRUG
Also known as: Paraplatin
Arm C: Carboplatin/Paclitaxel + BMS-906024Arm F: Carboplatin/Paclitaxcel and BMS-906024
LeucovorinDRUG
Arm B: FOLFIRI (5FU, Leucovorin, Irinotecan) + BMS-906024
IrinotecanDRUG
Also known as: Camptosar
Arm B: FOLFIRI (5FU, Leucovorin, Irinotecan) + BMS-906024
BMS-906024DRUG
Also known as: Notch inhibitor
Arm A: Paclitaxel + BMS-906024Arm B: FOLFIRI (5FU, Leucovorin, Irinotecan) + BMS-906024Arm C: Carboplatin/Paclitaxel + BMS-906024Arm D: Paclitaxel + BMS-906024Arm F: Carboplatin/Paclitaxcel and BMS-906024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Usc/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Local Institution

Brussels, 1000, Belgium

Location

Local Institution

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution

Ottawa, Quebec, K1H 8L6, Canada

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

PaclitaxelFluorouracilCarboplatinLeucovorinIrinotecanBMS-906024

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoordination ComplexesFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCamptothecinAlkaloids

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 31, 2012

Study Start

October 12, 2012

Primary Completion

May 3, 2017

Study Completion

May 8, 2017

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

BE(1)CA(3)US(1)