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

NCT00560716 | Terminated Phase 1

• 1 other identifier: CYC116-06-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Safety and tolerability; SAEs and AEs

  over the course of study

Study Arms (1)

CYC116

EXPERIMENTAL

CYC116 dose escalation first-in-human evaluation

Drug: CYC116

Interventions

CYC116 DRUG

Dose escalation of CYC116

Also known as: Aurora kinase inhibitor

CYC116

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyclacel Pharmaceuticals, Inc.: lead

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

4-methyl-5-(2-(4-morpholinophenylamino)pyrimidin-4-yl)thiazol-2-amine

Study Officials

• Judy H Chiao, MD

  Cyclacel Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 16, 2007
• First Posted: November 20, 2007
• Study Start: June 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)