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A Phase I and Pharmacokinetic Study of SR-45023A Administered Once Every 7 Days

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

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Trial Information

A Phase I and Pharmacokinetic Study of SR-45023A Administered Once Every 7 Days

OBJECTIVES: I. Determine the maximum tolerated dose of SR-45023A in patients with locally
advanced or metastatic solid tumors. II. Determine the quantitative and qualitative toxic
effects of SR-45023A in these patients. III. Assess the plasma and urine pharmacokinetics of
SR-45023A and relate these to drug effects, if possible, in these patients. IV. Determine
any preliminary antitumor activity of SR-45023A in these patients.

OUTLINE: This is a dose escalation study. Patients receive oral SR-45023A weekly. Treatment
continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SR-45023A until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose limiting toxicity. Patients are followed for up to 1 month.

PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or
metastatic solid tumors refractory to standard therapy or for which no standard therapy
exists (surgery, radiotherapy, and/or chemotherapy) Measurable or evaluable disease by
medical photograph, plain x-ray, CT, MRI, palpation, or serum tumor markers at least 2
times upper limit of normal No symptomatic, progressive brain metastases by CT or MRI scan
No cerebral edema No leukemia or multiple myeloma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 9.0 g/dL No coagulation disorders Hepatic:
Bilirubin normal AST and ALT no greater than 3 times upper limit of normal (ULN) (no
greater than 5 times ULN if liver involvement) PT or INR, and PTT normal Renal: Creatinine
no greater than 1.5 mg/dL Cardiovascular: No cardiac conduction abnormalities Other: Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No active or uncontrolled infection No other concurrent severe disease No
known hypersensitivity to SR-45023A analogs No concurrent or recent (within past 6 months)
small bowel obstruction, symptoms of small bowel obstruction, or any other
gastrointestinal disease impacting absorption of study drug No psychiatric disorders or
geographic distance that would prevent compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See
Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks since
carboplatin, mitomycin, or nitrosoureas) and recovered No prior SR-45023A No other
concurrent chemotherapy Endocrine therapy: No concurrent steroid therapy for brain disease
No concurrent hormonal cancer therapy (except contraception, hormone replacement therapy,
or corticosteroids) Radiotherapy: See Disease Characteristics At least 4 weeks since prior
radiotherapy and recovered No concurrent radiotherapy (except symptomatic radiotherapy for
pathologic fractures) Surgery: At least 4 weeks since prior surgery and recovered Other:
At least 4 weeks since prior investigational agents No other concurrent investigational
agents No concurrent anticoagulation therapy (e.g., heparin) except low dose warfarin for
central venous catheter patency No concurrent digoxin, beta blockers, or calcium channel
blockers No concurrent H2 histamine inhibitors (e.g., ranitidine, famotidine, or
cimetidine), proton pump inhibitors (e.g., omeprazole or lansoprazole), or other drugs
that might interfere with study drug absorption

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Kathleen Nolte

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

April 1999

Completion Date:

Related Keywords:

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



Institute for Drug Development San Antonio, Texas  78245-3217