A Phase I Pharmacologic Study of CYC116, an Oral Aurora Kinase Inhibitor, in Patients With Advanced Solid Tumors

Phase 1

Terminated

• Conditions: Solid Tumors
• Interventions: Drug: CYC116

• Registration Number: NCT00560716
• Lead Sponsor: Cyclacel Pharmaceuticals, Inc.

Brief Summary

This is a phase I study of an investigational cancer drug, CYC116, in patients with advanced solid tumors.

Detailed Description

Phase I study of an investigational cancer drug, CYC116, an Aurora kinase inhibitor, in patients with advanced solid tumors.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-11-16
• Study First Submitted QC: 2007-11-16
• Study First Posted: 2007-11-20
• Primary Completion: 2009-01
• Study Completion: 2009-11
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Incurable advanced solid tumors that did not respond to conventional therapy or for which no effective therapy exists
• Age >=18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy ≥ 3 months
• Evaluable disease
• Adequate bone marrow function
• Adequate renal function
• Adequate liver function
• At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
• Able to swallow capsules
• At least 3 weeks from major surgery
• Agree to practice effective contraception

Exclusion Criteria

• Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI scan performed at 4 weeks or longer after the last treatment for 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
CYC116	CYC116	CYC116 dose escalation first-in-human evaluation

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	over the course of study	Safety and tolerability; SAEs and AEs

Trial Locations

Locations (2)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States