NCT01018745

Brief Summary

The purpose of this clinical study is to establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

January 7, 2011

Status Verified

June 1, 2010

Enrollment Period

6 months

First QC Date

November 24, 2009

Last Update Submit

January 6, 2011

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • To establish the MTD and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors

    Within the first 28 days

Secondary Outcomes (4)

  • To assess the safety and tolerability of multiple doses of BMS-907351 (XL184) administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors

    Day 1, 2, 5, 8, 15, 19, 20, 29 and every 2 weeks thereafter

  • To assess plasma pharmacokinetics (PK) of oral administration of BMS-907351 (XL184) and the metabolite(s) in subjects with advanced or metastatic solid tumors

    Day 1, 5, 15, 19 and 29

  • To assess tumor response (preliminary anti-tumor activity) after repeated administration of BMS-907351 (XL184)

    Every 8 weeks

  • To assess the pharmacodynamic correlates of BMS-907351 (XL184) activity

    Day 1, 5, 15, 19, 29 and every 4 weeks thereafter

Study Arms (1)

BMS-907351 (XL184)

EXPERIMENTAL
Drug: BMS-907351 (XL184)

Interventions

BMS-907351 (XL184)DRUG

Capsules, Oral, 25, 50, 75, 100, 125 and 175 mg, Once daily, Until disease progression or unacceptable toxicity became apparent

BMS-907351 (XL184)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
  • Life expectancy of at least 3 months
  • Eastern Cooperative Oncology Group performance 0-2

You may not qualify if:

  • Subject has uncontrolled intercurrent illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Chuo-Ku, Tokyo, 104-0045, Japan

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

cabozantinib

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

January 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

January 7, 2011

Record last verified: 2010-06

Locations

JP(1)