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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00999401
Recruitment Status : Recruiting
First Posted : October 21, 2009
Last Update Posted : May 3, 2016
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.

October 19, 2009
October 21, 2009
May 3, 2016
April 2009
July 2018   (Final data collection date for primary outcome measure)
maximum tolerated dose [ Time Frame: 1-3 months ]
Same as current
Complete list of historical versions of study NCT00999401 on Archive Site
  • tumor response rate [ Time Frame: 1-3 months ]
  • pharmacodynamic effects in skin and peripheral mononuclear cells [ Time Frame: 1-3 months ]
Same as current
Not Provided
Not Provided
A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
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.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Tumors
Drug: sapacitabine and seliciclib
sequential or concomitant administration of sapacitabine and seliciclib
Experimental: sapacitabine and seliciclib
Sequential or concomitant administration of sapacitabine and seliciclib
Intervention: Drug: sapacitabine and seliciclib
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2018
July 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
United States
Not Provided
Not Provided
Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Geoffrey Shapiro, M.D. Dana-Farber Cancer Institute
Principal Investigator: Sara Tolaney, M.D. Dana-Farber Cancer Institute
Cyclacel Pharmaceuticals, Inc.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP