NCT01086267

Brief Summary

The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when administered alone or in combination with cetuximab

Trial Health

90
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1 colorectal-cancer

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_1 colorectal-cancer

Geographic Reach
2 countries

3 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

March 11, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

March 11, 2010

Last Update Submit

June 23, 2016

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Toxicity will be evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3

    Assessments every 1-2 weeks while receiving study drug

Secondary Outcomes (7)

  • Efficacy as determined by estimates of objective response rates and response duration

    Efficacy measured at least every 8 weeks while receiving study drug

  • Pharmacodynamics (PD) will be assessed by evaluating markers of RAS/RAF pathway activity

    PD assessed during the first 4 weeks on study

  • Pharmacokinetics (PK) for BMS-908662 as determined by minimum observed concentrations [Cmin].

    PK measured during first 4 weeks on study

  • Pharmacokinetics (PK) for BMS-908662 as determined by maximum observed concentrations [Cmax].

    PK measured during first 4 weeks on study

  • Pharmacokinetics (PK) for BMS-908662 as determined by time of maximum observed concentration [Tmax].

    PK measured during first 4 weeks on study

  • +2 more secondary outcomes

Study Arms (4)

BMS-908662 (A1)

EXPERIMENTAL

Phase 1

Drug: BMS-908662

Cetuximab (A1)

EXPERIMENTAL

Phase 1

Drug: Cetuximab

BMS-908662 (B1)

EXPERIMENTAL

Phase 2

Drug: BMS-908662

BMS-908662 + Cetuximab (B2)

EXPERIMENTAL

Phase 2

Drug: BMS-908662Drug: Cetuximab

Interventions

BMS-908662DRUG

Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), Continuously

BMS-908662 (A1)
CetuximabDRUG

Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously

BMS-908662 + Cetuximab (B2)Cetuximab (A1)

Eligibility Criteria

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

You may qualify if:

  • Subjects with K-RAS (codon 12 or 13) or B -RAF (V600E) mutation positive advanced or metastatic colorectal cancer who have relapsed or are refractory to 2 or more standard systemic anticancer regimes for metastatic disease, or are intolerant to existing therapies.
  • Histologic or cytologic confirmation of the diagnosis.
  • Eastern Cooperative Oncology Group (ECOG) ≤ 1
  • Adequate organ \& marrow function.

You may not qualify if:

  • Uncontrolled or significant cardiovascular disease.
  • Phase 2: Prior therapy with a RAF inhibitor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Oncology Research Associates D/B/A

Scottsdale, Arizona, 85258, United States

Location

Usc Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Local Institution

Ottawa, Ontario, K1H 1C3, Canada

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

BMS 908662Cetuximab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 11, 2010

First Posted

March 15, 2010

Study Start

July 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

June 27, 2016

Record last verified: 2016-06

Locations

CA(1)US(2)