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The Food-Effect Bioavailability Study of Ro 31-7453, a Novel Cell Cycle Inhibitor, in Stable Patient Volunteers With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

The Food-Effect Bioavailability Study of Ro 31-7453, a Novel Cell Cycle Inhibitor, in Stable Patient Volunteers With Solid Tumors


OBJECTIVES: I. Assess the impact of food on the bioavailability of Ro 31-7453 in patients
with locally advanced or metastatic solid tumors.

OUTLINE: This is a randomized, crossover study. Patients are randomized to one of two
treatment arms. Arm I: Patients receive oral Ro 31-7453 under fasting conditions on day 1.
After a 1-week washout period, patients receive oral Ro 31-7453 under fed conditions. Arm
II: Patients receive fed treatment as in arm I on day 1. After a 1-week washout period,
patients receive fasted treatment as in arm I. Both arms: At the start of week 3, patients
may continue to receive oral Ro 31-7453 every 12 hours on days 1-4. Treatment repeats every
3 weeks for at least 24 weeks in the absence of disease progression or unacceptable
toxicity. Patients are followed at 7 days.

PROJECTED ACCRUAL: A total of 10 patients (5 per arm) will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or
metastatic solid tumor for which no standard therapy is available No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: Hemoglobin at least 9 g/dL WBC at least 3,000/mm3
Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater
than 1.5 times ULN (4 times ULN for liver metastases) Alkaline phosphatase no greater than
2.5 times ULN (4 times ULN for liver or bone metastases) Renal: Creatinine no greater than
1.5 times ULN Cardiovascular: No history or clinical signs of significant cardiovascular
disease Other: No other serious concurrent illness No greater than grade II neuropathy No
evidence of gastrointestinal dysfunction No intolerance to a high-fat meal Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy
Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or
nitrosoureas) Endocrine therapy: At least 2 weeks since prior endocrine therapy (except
for antiandrogen therapy) Concurrent antiandrogen therapy allowed Concurrent
corticosteroids allowed if stable dose for at least 2 weeks prior to study Radiotherapy:
At least 3 weeks since prior radiotherapy Surgery: Not specified Other: No prior
enrollment in this study At least 4 weeks since prior investigational drugs No other
concurrent investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven Soignet, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

00-118

NCT ID:

NCT00014365

Start Date:

October 2000

Completion Date:

October 2001

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021