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

• ClinicalTrials.gov Identifier: NCT02552953
• Recruitment Status: Completed
• First Posted: September 17, 2015
• Last Update Posted: January 25, 2024
• Sponsor: Cyclacel Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Cyclacel Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: September 11, 2015
• First Posted Date: September 17, 2015
• Last Update Posted Date: January 25, 2024
• Actual Study Start Date: September 28, 2015
• Actual Primary Completion Date: October 4, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 21, 2019): Number of patients who experience dose-limiting toxicities [ Time Frame: cycle 1(each cycle is 21 -28 days) ]
• Original Primary Outcome Measures (submitted: September 16, 2015): Number of patients who experience dose-limiting toxicities [ Time Frame: cycle 1(each cycle is 28 days) ]

Current Secondary Outcome Measures (submitted: August 21, 2019)

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

Original Secondary Outcome Measures (submitted: September 16, 2015)

• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Brief Summary: 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cancer
• Intervention: Drug: CYC065

Study Arms

• Experimental: CYC065 - 4 hour infusion (Part 1 completed)
  CYC065 will be administered by 4 -hour infusion every 3 weeks.
  Intervention: 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
  Intervention: Drug: CYC065
• Experimental: CYC065 - Oral (Part 3 - ongoing)
  CYC065 will be administered orally on Days 1, 2, 8 and 9 every 3 weeks
  Intervention: Drug: CYC065

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 24, 2024): 60
• Original Estimated Enrollment (submitted: September 16, 2015): 35
• Actual Study Completion Date: August 25, 2023
• Actual Primary Completion Date: October 4, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02552953
• Other Study ID Numbers: CYC065-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Cyclacel Pharmaceuticals, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Cyclacel Pharmaceuticals, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Geoffrey Shapiro, MD; Dana-Farber Cancer Institute

• PRS Account: Cyclacel Pharmaceuticals, Inc.
• Verification Date: January 2024