Clinical Trials /

A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers

NCT02552953

Description:

This is an open-label, single arm, dose escalation study in patients with advanced cancers.

Related Conditions:
  • Hematopoietic and Lymphoid Malignancy
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers
  • Official Title: A Phase I Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers

Clinical Trial IDs

  • ORG STUDY ID: CYC065-01
  • NCT ID: NCT02552953

Conditions

  • Cancer

Interventions

DrugSynonymsArms
CYC065CYC065

Purpose

This is an open-label, single arm, dose escalation study in patients with advanced cancers.

Detailed Description

      This is an open-label, single arm, dose escalation study in patients with advanced cancers.
      Treatment will be administered on an outpatient basis.
    

Trial Arms

NameTypeDescriptionInterventions
CYC065ExperimentalCYC065 will be administered every 3 weeks.
  • CYC065

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed solid tumors or lymphomas that is
             metastatic or unresectable and for which standard curative or palliative measures do
             not exist or are no longer effective

          -  18 years or older

          -  ECOG performance status 0-1

          -  Life expectancy ≥ 3 months

          -  Evaluable disease

          -  Adequate organ functions

          -  4 weeks from prior chemotherapy ( 6 weeks for mitomycin C and nitrosourea) ,
             immunotherapy, investigational anti-cancer therapy, radiation therapy; and have
             recovered from prior toxicities

          -  At least 4 weeks from major surgery

          -  Agree to practice effective contraception

          -  Agree to follow protocol required evaluations

          -  Ability to understand and willingness to sign the informed consent form

        Exclusion Criteria:

          -  Previously untreated CNS metastasis or progressive CNS metastasis

          -  Currently receiving radiotherapy, biological therapy, or any other investigational
             agents

          -  Uncontrolled intercurrent illness

          -  Pregnant or lactating women

          -  Known to be HIV-positive

          -  Known 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:Number of patients who experience dose-limiting toxicities
Time Frame:cycle 1(each cycle is 28 days)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Plasma concentrations
Time Frame:cycle 1(each cycle is 28 days)
Safety Issue:
Description:
Measure:Half-life of CYC065
Time Frame:cycle 1(each cycle is 28 days)
Safety Issue:
Description:
Measure:changes in certain protein levels in peripheral white blood cells by western blots
Time Frame:cycle 1(each cycle is 28 days)
Safety Issue:
Description:
Measure:Thymidine Kinase- 1 (TK-1) level in blood
Time Frame:participants will be followed for the during of the study which is expected to be average of 24 weeks
Safety Issue:
Description:

Details

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

Last Updated

September 24, 2015