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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: sapacitabine and seliciclib

• Registration Number: NCT00999401
• Lead Sponsor: Cyclacel Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-10-19
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Primary Completion: 2019-07-16
• Study Completion: 2019-08-13
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sapacitabine and seliciclib	sapacitabine and seliciclib	Sequential or concomitant administration of sapacitabine and seliciclib

Primary Outcome Measures

Name	Time	Method
maximum tolerated dose	1-3 months	MTD of both sapacitabine and seliciclib administered sequentially in advanced solid tumor patients

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States