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Phase I Open-Label Study of the Safety, Toleration and Pharmacokinetics of CP-609,754, a Farnesyl Transferase Inhibitor, in Subjects With Advanced Malignant Tumors

Phase 1
18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Open-Label Study of the Safety, Toleration and Pharmacokinetics of CP-609,754, a Farnesyl Transferase Inhibitor, in Subjects With Advanced Malignant Tumors

OBJECTIVES: I. Determine the safety, tolerability, pharmacokinetics, and maximum tolerated
dose of CP-609,754 in patients with advanced solid tumors. II. Determine the predictability,
duration, intensity, onset, reversibility, and dose relationship of any observed toxicities
in these patients when treated with this regimen. III. Determine any preliminary evidence of
antitumor activity of this treatment as assessed by response rate and time to disease
progression in this patient population.

OUTLINE: This is a dose escalation study. Patients receive oral CP-609,754 1-2 times daily.
Treatment continues every 28 days for 12 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CP-609,754 until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 3 or 6 patients experience dose limiting toxicities. Patients are
followed at 4 weeks.

PROJECTED ACCRUAL: Approximately 44-56 patients will be accrued for this study within 12

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumor No
standard curative therapy exists OR Refractory OR Disease progression while on therapy
Measurable disease No brain metastases or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST and ALT no greater
than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver
metastases) Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at
least 60 mL/min Cardiovascular: No prior hemorrhagic or thrombotic cerebrovascular events
including transient ischemic attacks No clinically significant or unstable cardiac disease
No myocardial infarction within past 6 months No serious cardiac arrhythmia or conduction
abnormality Pulmonary: No chronic obstructive pulmonary disease requiring hospitalization
within past year Other: Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective barrier contraception Female patients must use barrier contraception
plus a second form of effective contraception for at least 3 months prior to and during
study No other serious concurrent systemic disorders that would preclude study No
uncontrolled diabetes mellitus, thyroid disease, or seizure disorder No active neurologic
or psychiatric disease No clinically apparent uncontrolled infection (e.g., HIV, hepatitis
B or C) No known sensitivity to imidazole containing drugs (e.g., clotrimazole,
oxiconazole, sulconazole, econazole, etoconazole, metronidazole, or ketoconazole) No
clinically significant gastrointestinal abnormalities requiring intravenous alimentation
No malabsorption syndrome or active peptic ulcer No other lab abnormalities (i.e.,
electrolytes, uric acid, calcium, phosphorous, or glucose) that would preclude study No
other malignancy in past 5 years except nonmelanomatous skin cancer or carcinoma in situ
of the breast or cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and
recovered No prior bone marrow transplantation Chemotherapy: At least 4 weeks since prior
chemotherapy (6 weeks for carboplatin, nitrosoureas, or mitomycin) and recovered Endocrine
therapy: At least 1 week since prior hormonal therapy and recovered Concurrent hormone
replacement therapy allowed No concurrent chronic steroid therapy Radiotherapy: At least 4
weeks since prior radiotherapy and recovered No prior radiotherapy to study lesions or to
more than 30% of bone marrow containing areas Surgery: Not specified Other: At least 4
weeks since other prior investigational drugs No other concurrent investigational drugs
Any regimens for other concurrent diseases or medical conditions must be stable for at
least 4 weeks

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Daniel M. Sullivan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Federal Government

Study ID:




Start Date:

June 2000

Completion Date:

Related Keywords:

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



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612