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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00999401
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : December 22, 2021
Sponsor:
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: sapacitabine and seliciclib Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
Study Start Date : April 2009
Actual Primary Completion Date : July 16, 2019
Actual Study Completion Date : August 13, 2019

Arm Intervention/treatment
Experimental: sapacitabine and seliciclib
Sequential or concomitant administration of sapacitabine and seliciclib
Drug: sapacitabine and seliciclib
sequential or concomitant administration of sapacitabine and seliciclib
Other Name: CYC682 and CYC202




Primary Outcome Measures :
  1. maximum tolerated dose [ Time Frame: 1-3 months ]
    MTD of both sapacitabine and seliciclib administered sequentially in advanced solid tumor patients


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999401


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Geoffrey Shapiro, M.D. Dana-Farber Cancer Institute
Principal Investigator: Sara Tolaney, M.D. Dana-Farber Cancer Institute
Publications of Results:
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.

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Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00999401    
Other Study ID Numbers: CYC682-07
First Posted: October 21, 2009    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: December 2021
Additional relevant MeSH terms:
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Neoplasms
Roscovitine
Sapacitabine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action