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

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ClinicalTrials.gov Identifier: NCT02552953
Recruitment Status : Unknown
Verified September 2015 by Cyclacel Pharmaceuticals, Inc..
Recruitment status was:  Recruiting
First Posted : September 17, 2015
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is an open-label, single arm, dose escalation study in patients with advanced cancers.

Condition or disease Intervention/treatment Phase
Cancer Drug: CYC065 Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers
Study Start Date : September 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016
Arms and Interventions

Arm Intervention/treatment
Experimental: CYC065
CYC065 will be administered every 3 weeks.
Drug: CYC065


Outcome Measures

Primary Outcome Measures :
  1. Number of patients who experience dose-limiting toxicities [ Time Frame: cycle 1(each cycle is 28 days) ]

Secondary Outcome Measures :
  1. Plasma concentrations [ Time Frame: cycle 1(each cycle is 28 days) ]
  2. Half-life of CYC065 [ Time Frame: cycle 1(each cycle is 28 days) ]
  3. changes in certain protein levels in peripheral white blood cells by western blots [ Time Frame: cycle 1(each cycle is 28 days) ]
  4. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552953


Contacts
Contact: Judy Chiao, MD 908-517-7330

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Geoffrey Shapiro, MD         
Contact: Andrew Wolanski, NP    617.632.6623    Andrew_wolanski@dfci.harvard.edu   
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
Principal Investigator: Geoffrey Shapiro, MD Dana-Farber Cancer Institute
More Information

Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02552953     History of Changes
Other Study ID Numbers: CYC065-01
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Cyclin-Dependent Kinase Inhibitor Proteins
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action