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

NCT ID: NCT02552953

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-28
• Study Completion Date: 2023-08-25

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.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CYC065 - 4 hour infusion (Part 1 completed)

CYC065 will be administered by 4 -hour infusion every 3 weeks.

Group Type: EXPERIMENTAL

CYC065

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

CYC065

Intervention Type: DRUG

CYC065 - Oral (Part 3 - ongoing)

CYC065 will be administered orally on Days 1, 2, 8 and 9 every 3 weeks

Group Type: EXPERIMENTAL

CYC065

Intervention Type: DRUG

Interventions

CYC065

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cyclacel Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geoffrey Shapiro, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

CYC065-01

Identifier Type: -

Identifier Source: org_study_id