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

NCT ID: NCT00999401

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2019-08-13

Brief Summary

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

Detailed Description

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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.

Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sapacitabine and seliciclib

Sequential or concomitant administration of sapacitabine and seliciclib

Group Type EXPERIMENTAL

sapacitabine and seliciclib

Intervention Type DRUG

sequential or concomitant administration of sapacitabine and seliciclib

Interventions

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sapacitabine and seliciclib

sequential or concomitant administration of sapacitabine and seliciclib

Intervention Type DRUG

Other Intervention Names

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CYC682 and CYC202

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cyclacel Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geoffrey Shapiro, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Sara Tolaney, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT

Other Identifiers

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CYC682-07

Identifier Type: -

Identifier Source: org_study_id