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

December 7, 2021 updated by: Cyclacel Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sapacitabine and seliciclib
Sequential or concomitant administration of sapacitabine and seliciclib
sequential or concomitant administration of sapacitabine and seliciclib
Other Names:
  • CYC682 and CYC202

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum tolerated dose
Time Frame: 1-3 months
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
Time Frame: 1-3 months
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
Time Frame: 1-3 months
PD effect of the sequential treatment of sapacitabine and seliciclib in patients with advanced solid tumors.
1-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Geoffrey Shapiro, M.D., Dana-Farber Cancer Institute
  • Principal Investigator: Sara Tolaney, M.D., Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Shapiro GI, et al. Responses to sequential sapacitabine and seliciclib in patients with BRCA-deficient solid tumors. Cancer Res April 15, 2013 73; LB-202.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

July 16, 2019

Study Completion (Actual)

August 13, 2019

Study Registration Dates

First Submitted

October 19, 2009

First Submitted That Met QC Criteria

October 20, 2009

First Posted (Estimate)

October 21, 2009

Study Record Updates

Last Update Posted (Actual)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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