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Phase I Study of BMS-214662 Oral Dosing in Patients With Advanced Malignancies

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of BMS-214662 Oral Dosing in Patients With Advanced Malignancies

OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, recommended
phase II dose, and safety of BMS-214662 in patients with advanced solid tumors. II.
Determine the pharmacokinetics of BMS-214662 in these patients. III. Assess the absolute
oral bioavailability of BMS-214662 using a capsule and single intravenous dose in these
patients. IV. Determine any preliminary evidence of antitumor activity of BMS-214662 in
these patients.

OUTLINE: This is a dose escalation study. Patients receive BMS-214662 IV over 1 hour on day
-7, followed by oral BMS-214662 daily on days 0-14 for course 1 only. Beginning with course
2, patients receive oral BMS-214662 twice daily for 14 days. Treatment continues every 3
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 fewer than 2 of 6 patients experience
dose limiting toxicity. Patients are followed every 4 weeks until toxicities resolve.

PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 12-18

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumor
that is refractory to standard therapy or for which no effective therapy exists No active
brain metastases including evidence of cerebral edema by CT or MRI scan, progression from
prior imaging study, any requirement for steroids, or clinical symptoms

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5
mg/dL ALT and AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine
less than 1.5 times ULN Cardiovascular: No uncontrolled or significant cardiac disease No
myocardial infarction within the past 6 months No congestive heart failure (with or
without therapy) No history of atrial or ventricular arrhythmias No history of second or
third degree heart block No prolonged QTc interval on electrocardiogram Pulmonary: No
uncontrolled or significant pulmonary disease Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception No serious uncontrolled
medical disorder or active infection No dementia or altered mental status No prior or
concurrent gastrointestinal disease within past 6 months No history of malabsorption No
impaired oral ingestion (e.g., patients with feeding tubes)

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy
Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or
mitomycin) No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics
No concurrent hormonal therapy (except replacement hormone therapy) Radiotherapy: At least
4 weeks since prior radiotherapy No prior radiotherapy to greater than 25% of the bone
marrow No concurrent radiotherapy Surgery: No prior surgery that would impact the
absorption of BMS-214662 Other: At least 4 weeks since prior investigational agents No
other concurrent experimental anticancer medications No prior CYP3A4 substrates within 1
week before, during, and for at least 1 week after study

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David R. Spriggs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 1999

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021