NCT00005973

Brief Summary

Phase I trial to study the effectiveness of BMS-214662 in treating patients who have solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Trial Health

80
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 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

Study Start

First participant enrolled

April 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

4.3 years

First QC Date

July 5, 2000

Last Update Submit

January 22, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol SpecificUnspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • MTD, defined as the dose level among the 9 levels studied having toxicity rate closest to a target of 33%, graded according to CTC version 2.0

    Toxicity is defined as grade 3, 4 non-hematologic and grade 4 hematologic (neutropenia and thrombocytopenia) toxicity. The continual reassessment method (CRM) will be used.

    Up to 6 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Patients receive BMS-214662 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Drug: BMS-214662Other: laboratory biomarker analysis

Interventions

BMS-214662DRUG

Given IV

Also known as: farnesyltransferase inhibitor BMS-214662, FTI BMS 214662
Treatment
laboratory biomarker analysisOTHER

Correlative studies

Treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of malignant solid tumor for which a standard curative therapy does not exist
  • Performance status - Karnofsky 70-100%
  • At least 6 months
  • WBC at least 3,000/mm\^3
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 10.0 g/dL
  • Bilirubin no greater than 2.0 mg/dL
  • AST no greater than 2 times upper limit of normal
  • Albumin at least 3.0 g/dL
  • Creatinine no greater than 1.5 mg/dL
  • No uncontrolled heart disease
  • No history of clinically significant cardiac arrhythmia that could be exacerbated by QT interval prolongation
  • Corrected QT interval no greater than 450 milliseconds
  • Must not require total parenteral nutrition
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

7-cyano-2,3,4,5-tetrahydro-1-(1H-imidazol-4-ylmethyl)-3-(phenylmethyl)-4-(2-thienylsulfonyl)-1H-1,4-benzodiazepine

Study Officials

  • Vassiliki Papadimitrakopoulou

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

April 1, 2000

Primary Completion

July 1, 2004

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(1)