NCT00670189

Brief Summary

The purpose of this study is to determine the safety of BMS-833923 (XL139) in patients with advanced or metastatic cancers and determine the recommended phase 2 dose range and schedule

Trial Health

90
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_1

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

April 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

5.8 years

First QC Date

April 29, 2008

Last Update Submit

August 13, 2014

Conditions

Hedgehog PathwaySmoothenedBasal Cell Carcinoma (BCC)Basal Cell Nevoid Syndrome (BCNS)

Outcome Measures

Primary Outcomes (1)

  • Use National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) to establish the maximum tolerated dose, a recommended Phase 2 dose range and schedule, and safety profile of BMS-833923

    Use NCI CTCAE to monitor safety assessments including physical findings, laboratory tests, and radiographic assessments to establish the maximum tolerated dose and recommended Phase 2 dose range and schedule of BMS-833923

    On average a minimum of 60 days up to 3 years

Secondary Outcomes (12)

  • Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose and during daily dosing: Maximum observed plasma concentration (Cmax)

    Study day 1-7, 36

  • Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose and during daily dosing: Time of maximum observed plasma concentration (Tmax)

    Study day 1-7, 36

  • Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)] of BMS-833923 (XL139)

    Study day 1-7

  • Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-833923 (XL139)

    Study day 1-7

  • Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose: Plasma half-life (T-HALF) of BMS-833923 (XL139)

    Study day 1-7

  • +7 more secondary outcomes

Study Arms (1)

BMS-833923

EXPERIMENTAL
Drug: BMS-833923 (XL139)

Interventions

BMS-833923 (XL139)DRUG

Capsules, Oral, 30 mg starting; dose escalation, Once daily, 37 days; additional days if receiving benefit

BMS-833923

Eligibility Criteria

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

You may qualify if:

  • Advanced or metastatic cancer (excluding cancer in the blood) or uncontrolled basal cell nevoid syndrome or sporadic basal cell carcinoma
  • Primary or metastatic tumor site accessible for biopsy
  • Ability to swallow capsules
  • Subjects with histologically confirmed, advanced stage IIIB or stage IV non-small cell lung cancer (NSCLC) with a primary histology of squamous carcinoma who have received prior systemic therapy for advanced NSCLC will be enrolled in Part 3

You may not qualify if:

  • Uncontrolled brain metastasis
  • Significant cardiovascular disease
  • Inadequate blood counts
  • Inadequate liver, kidney or lung function
  • Gastrointestinal disease within last 3 months
  • Infection with Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C or exposure to attenuated active immunizations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Southwest Texas Addiction Research And Tech (Start) Center

San Antonio, Texas, 78229, United States

Location

Local Institution

Toronto, Ontario, M5G 2M9, Canada

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

BMS-833923

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

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
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2008

First Posted

May 1, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

August 15, 2014

Record last verified: 2014-08

Locations

US(2)CA(1)