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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 : Completed
First Posted : September 17, 2015
Last Update Posted : January 25, 2024
Sponsor:
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
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
Actual Study Start Date : September 28, 2015
Actual Primary Completion Date : October 4, 2022
Actual Study Completion Date : August 25, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: CYC065 - 4 hour infusion (Part 1 completed)
CYC065 will be administered by 4 -hour infusion every 3 weeks.
 Drug: CYC065
Experimental: CYC065 - 1 hour infusion (Part 2 - ongoing)
CYC065 will be administered by 1 - hour infusion on Days 1, 2, 8, and 9 every 3 weeks
 Drug: CYC065
Experimental: CYC065 - Oral (Part 3 - ongoing)
CYC065 will be administered orally on Days 1, 2, 8 and 9 every 3 weeks
 Drug: CYC065


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients who experience dose-limiting toxicities [ Time Frame: cycle 1(each cycle is 21 -28 days) ]

Secondary Outcome Measures :
  1. Plasma concentrations [ Time Frame: cycle 1(each cycle is 21 -28 days) ]
  2. Half-life of CYC065 [ Time Frame: cycle 1(each cycle is 21 -28 days) ]
  3. changes in certain protein levels in peripheral white blood cells by western blots [ Time Frame: cycle 1(each cycle is 21 -28 days) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Geoffrey Shapiro, MD Dana-Farber Cancer Institute
More Information
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Responsible Party: Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02552953    
Other Study ID Numbers: CYC065-01
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: January 25, 2024
Last Verified: January 2024