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

This study is currently recruiting participants.

Verified by Cyclacel Pharmaceuticals, Inc., October 2009

First Received: October 19, 2009 Last Updated: October 20, 2009 History of Changes

Sponsor:	Cyclacel Pharmaceuticals, Inc.
Information provided by:	Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00999401

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: CS 682 Roscovitine

U.S. FDA Resources

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:	August 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
sapacitabine and seliciclib: Experimental 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

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 ( Judy H. Chiao, M.D./VP of Clinical Development and Regulatory Affairs )
Study ID Numbers:	CYC682-07
Study First Received:	October 19, 2009
Last Updated:	October 20, 2009
ClinicalTrials.gov Identifier:	NCT00999401 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Roscovitine

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 04, 2010