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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Cyclacel Pharmaceuticals, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00999401
First received: October 19, 2009
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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. The secondary objectives are to evaluate antitumor activity of this sequential 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: Allocation: Non-Randomized
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: 40
Study Start Date: February 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sapacitabine and seliciclib
Sequential administration of sapacitabine and seliciclib
Drug: sapacitabine and seliciclib
sequential administration of sapacitabine and seliciclib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • 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 ClinicalTrials.gov identifier: NCT00999401

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Geoffrey Shapiro, M.D.    617-632-4942      
Contact: Kristen Johnson, R.N.    617-632-5841      
Principal Investigator: Geoffrey Shapiro, M.D.         
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
Principal Investigator: Geoffrey Shapiro, M.D. Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00999401     History of Changes
Other Study ID Numbers: CYC682-07
Study First Received: October 19, 2009
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Roscovitine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014