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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Responses to sequential sapacitabine and seliciclib in patients with BRCA-deficient solid tumors 

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.

Responsible Party:	Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00999401 History of Changes
Other Study ID Numbers:	CYC682-07
First Posted:	October 21, 2009
Last Update Posted:	May 3, 2016
Last Verified:	November 2011

Additional relevant MeSH terms:

Roscovitine; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action