A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of CUDC-101 in Patients With Advanced Solid Tumors - Full Text View

Sponsor:	Curis, Inc.
Information provided by (Responsible Party):	Curis, Inc.
ClinicalTrials.gov Identifier:	NCT00728793

Purpose

This is a phase I, open-label, dose-escalation study of CUDC-101 in patients with advanced and refractory solid tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2(Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of CUDC-101.

Condition	Intervention	Phase
Tumors	Drug: CUDC-101	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Open-Label, Multiple Dose, Sequential Dose Escalation Study to Investigate the Safety and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced and Refractory Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Curis, Inc.:

Primary Outcome Measures:

To establish the maximum tolerated dose (MTD) for CUDC-101 and to assess the safety and tolerability of CUDC-101 in subjects with advanced and refractory solid tumors. [ Time Frame: Study treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the efficacy of CUDC-101 in subjects with advanced and refractory solid tumors. [ Time Frame: Study treatment period ] [ Designated as safety issue: No ]
To assess the pharmacokinetics of CUDC-101 in this patient population. [ Time Frame: Study treatment period ] [ Designated as safety issue: No ]
To evaluate pharmacodynamic biomarkers of CUDC-101 activity. [ Time Frame: Study treatment period ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	August 2008
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Doses will be given by intravenous infusion over 1 hour on days 1-5 of each treatment cycle. Total treatment cycle duration will be 14 days. Additional treatment cycles will be administered until the subjects withdraws consent, experiences unacceptable toxicity, or if there is documented tumor progression.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with advanced, refractory solid tumors and a histopathologically confirmed diagnosis
Subjects must have no further standard of care options or have refused standard therapy
Measurable or evaluable disease
Age ≥ 18 years
ECOG performance < 2
Life expectancy ≥ 3 months
If female, neither pregnant or lactating
If of child bearing potential, must use adequate birth control
Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL;
Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min/1.73m2
Total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. In subjects with documented liver metastases, the AST/ALT may be ≤ 5x ULN
Prothrombin time ≤1.5x ULN, unless receiving therapeutic anticoagulation
Serum magnesium and potassium within normal limits (may be supplement to achieve normal values)
Subjects with brain metastases are eligible if controlled on a stable dose ≤ 10mg prednisone/day or its equivalent dose of steroids
Able to render informed consent and to follow protocol requirements.

Exclusion Criteria:

Anticancer therapy within 4 weeks of study entry. Prostate cancer subjects on LHRH hormonal therapy may be enrolled and continue on this therapy.
Use of investigational agent(s) within 30 days of study entry
History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment.
Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
The following are permitted but should be used with caution and other suitable agents used if possible:
- Subjects receiving concomitant medications metabolized by CYP 3A4 and CYP 2D6
- CYP3A4 inducers
- CYP3A4 inhibitors
- Warfarin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728793

Locations

United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Texas
START (South Texas Accelerated Research Therapeutics)
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Curis, Inc.

Investigators

Principal Investigator:

Anthony Tolcher, M.D.

START (South Texas Accelerated Research Therapeutics)

More Information

Additional Information:

Curis, Inc. Company Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Curis, Inc.
ClinicalTrials.gov Identifier:	NCT00728793 History of Changes
Other Study ID Numbers:	CUDC-101-101
Study First Received:	August 1, 2008
Last Updated:	November 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Curis, Inc.:

Advanced Solid Tumors
EGFR
HDAC

Her2
Open-Label
Dose-Escalation

ClinicalTrials.gov processed this record on February 09, 2012