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

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ClinicalTrials.gov Identifier: NCT00999401
Recruitment Status : Unknown
Verified November 2011 by Cyclacel Pharmaceuticals, Inc..
Recruitment status was:  Recruiting
First Posted : October 21, 2009
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: sapacitabine and seliciclib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. maximum tolerated dose [ Time Frame: 1-3 months ]

Secondary Outcome Measures :
  1. tumor response rate [ Time Frame: 1-3 months ]
  2. pharmacodynamic effects in skin and peripheral mononuclear cells [ Time Frame: 1-3 months ]

Eligibility Criteria
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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
Contacts and Locations
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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 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.
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
More Information
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Additional Information:

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: May 3, 2016
Last Verified: November 2011
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