A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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A study of sequential administration of oral sapacitabine and oral Seliciclib in patients with advanced solid tumors.

Detailed Description
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The primary objective of this study is to determine the maximum tolerated dose (MTD) or recommended phase II doses of sapacitabine and seliciclib administered sequentially or concomitantly. The secondary objectives are to evaluate antitumor activity of this sequential or concomitant treatment and to explore the pharmacodynamic effect of this treatment in skin and peripheral blood mononuclear cells.

Official Title
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A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: sapacitabine and seliciclib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Incurable advanced solid tumors that are no longer responding to conventional therapy or for which no effective therapy exists; at the RD of Part 1, an extension cohort up to 20 patients with metastatic breast cancer who are known to be BRCA mutation carriers will be enrolled. Age 18 years or older ECOG 0-2 Life expectancy ≥ 3 months Evaluable disease Adequate bone marrow function Adequate renal function Adequate liver function At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities Able to swallow capsules At least 3 weeks from major surgery Agree to practice effective contraception Ability to understand and willingness to sign the informed consent form Exclusion Criteria: Previously untreated CNS metastases or progressive CNS metastases Currently receiving radiotherapy, biological therapy, or any other investigational agents Uncontrolled intercurrent illness including Pregnant or lactating women Known to be HIV-positive A history of active hepatitis B and/or hepatitis C infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sapacitabine and seliciclib<br>Sequential or concomitant administration of sapacitabine and seliciclib | Drug: sapacitabine and seliciclib<br>* sequential or concomitant administration of sapacitabine and seliciclib<br>* Other names: CYC682 and CYC202;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum tolerated dose | MTD of both sapacitabine and seliciclib administered sequentially in advanced solid tumor patients | 1-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor response rate | Anti-tumor activity of the sequential treatment of sapacitabine and seliciclib in patients with advanced solid tumors. | 1-3 months | 
| pharmacodynamic effects in skin and peripheral mononuclear cells | PD effect of the sequential treatment of sapacitabine and seliciclib in patients with advanced solid tumors. | 1-3 months |