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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by Cyclacel Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc. Identifier:
First received: October 19, 2009
Last updated: May 2, 2016
Last verified: November 2011
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.

Condition Intervention Phase
Advanced Solid Tumors
Drug: sapacitabine and seliciclib
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors

Resource links provided by NLM:

Further study details as provided by Cyclacel Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • maximum tolerated dose [ Time Frame: 1-3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • tumor response rate [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]
  • pharmacodynamic effects in skin and peripheral mononuclear cells [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2009
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sapacitabine and seliciclib
Sequential or concomitant administration of sapacitabine and seliciclib
Drug: sapacitabine and seliciclib
sequential or concomitant administration of sapacitabine and seliciclib


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00999401

United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Geoffrey Shapiro, M.D.    617-632-4942      
Contact: Tracy Bell, R.N.    617.632.3482      
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sara Tolaney, M.D.    617-632-2335      
Contact: Leilani Anderson, RN    617-632-3129      
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Principal Investigator: Geoffrey Shapiro, M.D. Dana-Farber Cancer Institute
Principal Investigator: Sara Tolaney, M.D. Dana-Farber Cancer Institute
  More Information

Additional Information:
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.

Responsible Party: Cyclacel Pharmaceuticals, Inc. Identifier: NCT00999401     History of Changes
Other Study ID Numbers: CYC682-07 
Study First Received: October 19, 2009
Last Updated: May 2, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 27, 2016