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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Cyclacel Pharmaceuticals, Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02552953
First Posted: September 17, 2015
Last Update Posted: September 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.
  Purpose
This is an open-label, single arm, dose escalation study in patients with advanced cancers.

Condition Intervention Phase
Cancer Drug: CYC065 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Cyclacel Pharmaceuticals, Inc.:

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

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

Estimated Enrollment: 35
Study Start Date: September 2015
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CYC065
CYC065 will be administered every 3 weeks.
Drug: CYC065

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: September 11, 2015
First Posted: September 17, 2015
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