BMS-214662 in Treating Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005973
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 23, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific Drug: BMS-214662 Other: laboratory biomarker analysis Phase 1

Detailed Description:


I. Determine the maximum tolerated dose of BMS-214662 in patients with solid tumors.

II. Evaluate intermediate biological endpoints as surrogates for the effectiveness of this drug in these patients.

III. Determine the nature of dose limiting toxicity of this drug in this patient population.

IV. Determine the recommended phase II regimen of this drug in these patients. V. Establish a pharmacologic and pharmacokinetic profile of this drug in these patients.

OUTLINE: This is a dose escalation study.

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.

Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities.

Patients are followed every 3 months for at least 24 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 (NSC 710086D) in Solid Tumors
Study Start Date : April 2000
Actual Primary Completion Date : July 2004

Arm Intervention/treatment
Experimental: Treatment
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-214662
Given IV
Other Names:
  • farnesyltransferase inhibitor BMS-214662
  • FTI BMS 214662
Other: laboratory biomarker analysis
Correlative studies

Primary Outcome Measures :
  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 [ Time Frame: Up to 6 weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • No manifestations of malabsorption syndrome due to prior surgery, gastrointestinal disease, or unknown reasons
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No signs or symptoms of acute infection requiring systemic therapy
  • No grade 3 or 4 neurotoxicity from prior anticancer treatment or neuropathy from any cause
  • No confusion, disorientation, or psychiatric illness that may preclude study
  • No more than 3 prior chemotherapy regimens
  • At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin) and recovered
  • No other concurrent antineoplastic agents
  • No concurrent hormonal anticancer therapy
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy
  • Prior drugs known to prolong the QT interval allowed if they can be safely discontinued for a time period equal to 4 elimination half-lives prior to administering study drug
  • No drugs known to prolong the QT interval during and for 24 hours after study drug
  • No concurrent therapy with known CYP3A4 substrates
  • No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005973

United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Vassiliki Papadimitrakopoulou M.D. Anderson Cancer Center

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00005973     History of Changes
Other Study ID Numbers: NCI-2012-02343
U01CA062461 ( U.S. NIH Grant/Contract )
CDR0000067960 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013

Additional relevant MeSH terms: