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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: CYC065

• Registration Number: NCT02552953
• Lead Sponsor: Cyclacel Pharmaceuticals, Inc.

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 Timeline

• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Study Start: 2015-09-28
• Primary Completion: 2022-10-04
• Study Completion: 2023-08-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of patients who experience dose-limiting toxicities	cycle 1(each cycle is 21 -28 days)

Secondary Outcome Measures

Name	Time	Method
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)
Plasma concentrations	cycle 1(each cycle is 21 -28 days)

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States