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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999401
• Other study ID #: CYC682-07
• Status: Completed
• Phase: Phase 1
• Start date: April 2009
• Est. completion date: August 13, 2019

Study information

• Verified date: December 2021
• Source: Cyclacel Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: August 13, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• sapacitabine and seliciclib
sequential or concomitant administration of sapacitabine and seliciclib

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cyclacel Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum tolerated dose	MTD of both sapacitabine and seliciclib administered sequentially in advanced solid tumor patients	1-3 months
Secondary	tumor response rate	Anti-tumor activity of the sequential treatment of sapacitabine and seliciclib in patients with advanced solid tumors.	1-3 months
Secondary	pharmacodynamic effects in skin and peripheral mononuclear cells	PD effect of the sequential treatment of sapacitabine and seliciclib in patients with advanced solid tumors.	1-3 months

External Links

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