Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Tumors

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

Study treatment period

Safety Issue:

Yes

Principal Investigator

Anthony Tolcher, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

START (South Texas Accelerated Research Therapeutics)

Authority:

United States: Food and Drug Administration

Study ID:

CUDC-101-101

NCT ID:

NCT00728793

Start Date:

August 2008

Completion Date:

April 2010

Related Keywords:

  • Tumors
  • Advanced Solid Tumors
  • EGFR
  • HDAC
  • Her2
  • Open-Label
  • Dose-Escalation

Name

Location

Karmanos Cancer InstituteDetroit, Michigan  48201
START (South Texas Accelerated Research Therapeutics)San Antonio, Texas  78229