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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552953
• Other study ID #: CYC065-01
• Status: Completed
• Phase: Phase 1
• Start date: September 28, 2015
• Est. completion date: August 25, 2023

Study information

• Verified date: May 2024
• Source: Cyclacel Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is an open-label, single arm, dose escalation study in patients with advanced cancers. Treatment will be administered on an outpatient basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 25, 2023
• Est. primary completion date: October 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• CYC065

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cyclacel Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who experience dose-limiting toxicities		cycle 1(each cycle is 21 -28 days)
Secondary	Plasma concentrations		cycle 1(each cycle is 21 -28 days)
Secondary	Half-life of CYC065		cycle 1(each cycle is 21 -28 days)
Secondary	changes in certain protein levels in peripheral white blood cells by western blots		cycle 1(each cycle is 21 -28 days)