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A Phase I Open Label, Multicenter, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Orally Administered CUDC-101 in Subjects With Advanced and Refractory Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

A Phase I Open Label, Multicenter, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Orally Administered CUDC-101 in Subjects With Advanced and Refractory Solid Tumors


Inclusion Criteria:



1. Subjects with a histopathologically confirmed diagnosis of advanced solid tumor.

2. Subjects must have no further standard of care options.

3. Measurable or non-measurable disease

4. Age ≥ 18 years

5. ECOG performance status ≤ 2

6. Life expectancy ≥ 3 months

7. Women of child bearing potential must have a negative serum pregnancy test.

8. Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL; creatinine ≤ 1.5x upper
limit of normal (ULN); total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. For subjects
with documented liver metastases, the AST/ALT may be ≤ 5x ULN

9. Serum magnesium and potassium within normal limits (may be supplemented to achieve
normal values).

10. Subjects with brain metastases are eligible if controlled on a stable dose of ≤ 10mg
prednisone/day or its equivalent dose of steroids.

11. Men and women of child bearing potential must agree to use adequate birth control
throughout their participation in the study and for 60 days following the last study
treatment.

12. Able to provide written informed consent and to follow protocol requirements.

Exclusion Criteria:

1. Systemic anticancer therapy within 28 days prior to study treatment. Subjects with
prostate cancer on LHRH hormonal therapy may be enrolled and continue on this
therapy.

2. Use of any investigational agent(s) within 21 days prior to study treatment.

3. Known human immunodeficiency virus (HIV) positive, hepatitis B surface
antigen-positive, or known or suspected active hepatitis C infection.

4. Subjects receiving moderate or strong CYP3A4 or CYP2D6 inhibitors within 7 days prior
to study treatment (See Appendix C for examples).

5. Serious infection requiring systemic antibiotic therapy within 14 days prior to study
treatment.

6. Known gastrointestinal condition that would interfere with swallowing or the oral
absorption or tolerance of CUDC-101.

7. Ongoing diarrhea of any grade (per NCI CTCAE v4.03).

8. Uncontrolled or severe cardiovascular disease, including myocardial infarct or
unstable angina within 6 months prior to study treatment, New York Heart Association
(NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring
medication for treatment, clinically significant pericardial disease, or cardiac
amyloidosis.

9. Unstable or clinically significant concurrent medical condition that would, in the
opinion of the Investigator, jeopardize the safety of a subject and/or their
compliance with the protocol.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose of oral CUDC-101 in subjects with advanced and refractory solid tumors

Outcome Description:

The highest dose level studied at which fewer than 2 out of 6 subjects (< 33%) experience a dose limiting toxicity (DLT).

Outcome Time Frame:

21 days (1 cycle of study treatment)

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

CUDC-101-105

NCT ID:

NCT01702285

Start Date:

September 2012

Completion Date:

March 2014

Related Keywords:

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

Name

Location

Karmanos Cancer InstituteDetroit, Michigan  48201
Southern Texas Accelerated Research TherapeuticsSan Antonio, Texas  78229