Know Cancer

or
forgot password

Phase I Study of R031-7453, a Novell Cell Cycle Inhibitor, Administered as Escalating Oral Doses in Adults With Solid Tumors: 4-Day Schedule


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

Thank you

Trial Information

Phase I Study of R031-7453, a Novell Cell Cycle Inhibitor, Administered as Escalating Oral Doses in Adults With Solid Tumors: 4-Day Schedule


OBJECTIVES: I. Determine the maximum tolerated dose of Ro 31-7453 in patients with solid
tumors. II. Determine the toxicity of Ro 31-7453 in this patient population. III. Evaluate
the pharmacokinetics and major metabolites of Ro 31-7453 in these patients. IV. Assess any
antitumor activity of Ro 31-7453 in these patients.

OUTLINE: This is a dose escalation study. Patients are treated on one of two treatment arms.
In the first stage, cohorts of 1 patient each on arm I receive oral Ro 31-7453 twice daily
on days 1-4, and cohorts of 1 patient each on arm II receive oral Ro 31-7453 once daily on
days 1-4 at two dose levels higher than for arm I. Dose escalation ceases for each arm with
the first instance of dose limiting toxicity (DLT). Two additional patients are entered at
the stopping dose for each arm. If no further DLT occurs, the study proceeds to the second
stage. In the second stage, dose escalation continues in increments of one dose level for
each dosing schedule (arms I and II). Cohorts of 3-6 patients receive escalating doses of Ro
31-7453 in the absence of DLT. If 2 of 6 patients experience DLT at a dose level, escalation
ceases and the maximum tolerated dose is defined as the previous dose level. Treatment
continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable
toxicity. After completion of the 8 courses, patients may continue treatment until disease
progression at the discretion of the investigator and the study sponsor. Patients are
followed at 4 weeks.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study over 18 months.

Inclusion Criteria


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

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 9 g/dL WBC at least
3,000/mm3 Granulocyte 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) ALT and/or AST no
greater than 2.5 times ULN (no greater than 4.0 times ULN if liver or bone metastasis
present) Alkaline phosphatase no greater than 2.5 times ULN (no greater than 4.0 times ULN
if liver or bone metastasis present) Renal: Creatinine no greater than 1.5 times ULN OR
Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients
must use effective contraception No history of other serious medical conditions

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or
nitrosoureas) Endocrine therapy: At least 4 weeks since prior hormonal therapy Concurrent
antiandrogen therapy allowed Radiotherapy: At least 4 weeks since prior extended field
radiotherapy Surgery: Not specified

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:

98-099

NCT ID:

NCT00003755

Start Date:

October 1998

Completion Date:

August 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