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

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

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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients who experience dose-limiting toxicities	cycle 1(each cycle is 21 -28 days)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cyclacel Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Geoffrey Shapiro, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2015
• Primary Completion (Actual): October 4, 2022
• Study Completion (Actual): August 25, 2023

Study Registration Dates

• First Submitted: September 11, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimated): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CYC065-01