Clinical Trials /

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

NCT00999401

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.

Related Conditions:
  • Breast Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Unknown status

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
  • Official Title: A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CYC682-07
  • NCT ID: NCT00999401

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
sapacitabine and seliciclibsapacitabine and seliciclib

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 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.

Trial Arms

NameTypeDescriptionInterventions
sapacitabine and seliciclibExperimentalSequential or concomitant administration of sapacitabine and seliciclib
  • sapacitabine and seliciclib

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:maximum tolerated dose
Time Frame:1-3 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:tumor response rate
Time Frame:1-3 months
Safety Issue:
Description:
Measure:pharmacodynamic effects in skin and peripheral mononuclear cells
Time Frame:1-3 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Cyclacel Pharmaceuticals, Inc.

Last Updated

May 2, 2016