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A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
Not Recruiting
Trial ID: NCT00476554
Purpose
This is an open label, randomized phase II study designed to evaluate the tolerability and
response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell
lymphoma (CTCL).
Official Title
A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma
Stanford Investigator(s)
Richard Hoppe
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Sunil Arani Reddy
Clinical Associate Professor, Medicine - Oncology
Eligibility
Inclusion Criteria:
- Adult patients with advanced CTCL
- Have had at least 2 systemic therapies
- Must have evaluable disease
- Eastern Cooperative Oncology Group performance status 0-2
- Adequate bone marrow, hepatic and renal function
- At least 3 weeks from prior therapies
- Not receiving topical steroids or have been on a stable dose of topical steroids for
at least 2 weeks
- Able to swallow capsules
- At least 3 weeks from major surgery
- Agree to practice effective contraception
- Able to understand and willing to sign the informed consent form
Exclusion Criteria:
- Receiving systemic steroids
- Receiving topical or systemic retinoids or vitamin A
- Receiving radiotherapy, biological therapy,or any other investigational agents
- Uncontrolled intercurrent illness
- Pregnant or lactating women
- Known to be HIV-positive
- Active hepatitis B and/or hepatitis C infection
Intervention(s):
drug: Sapacitabine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Daniel Navi
6507362300