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

NCT02552953 | Completed Phase 1

• 1 other identifier: CYC065-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients who experience dose-limiting toxicities

  cycle 1(each cycle is 21 -28 days)

Secondary Outcomes (3)

• 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)

Study Arms (3)

CYC065 - 4 hour infusion (Part 1 completed)

EXPERIMENTAL

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

Drug: CYC065

CYC065 - 1 hour infusion (Part 2 - ongoing)

EXPERIMENTAL

CYC065 will be administered by 1 - hour infusion on Days 1, 2, 8, and 9 every 3 weeks

Drug: CYC065

CYC065 - Oral (Part 3 - ongoing)

EXPERIMENTAL

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

Drug: CYC065

Interventions

CYC065 DRUG

CYC065 - 1 hour infusion (Part 2 - ongoing); CYC065 - 4 hour infusion (Part 1 completed); CYC065 - Oral (Part 3 - ongoing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older
• ECOG performance status 0-1
• Life expectancy ≥ 3 months
• Evaluable disease
• Adequate organ functions
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyclacel Pharmaceuticals, Inc.: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

CYC065

Study Officials

• Geoffrey Shapiro, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 17, 2015
• Study Start: September 28, 2015
• Primary Completion: October 4, 2022
• Study Completion: August 25, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

US (1)