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A Multicenter Phase 1 Clinical and Pharmacokinetic Study of DCC-2036 in Subjects With Leukemias (Ph+CML With T315I Mutation Only)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia

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Trial Information

A Multicenter Phase 1 Clinical and Pharmacokinetic Study of DCC-2036 in Subjects With Leukemias (Ph+CML With T315I Mutation Only)


Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be
eligible:

- Ph+ CML in Chronic Phase with T315I mutation

- 18 years or older

- The subject has an ECOG performance status of ≤ 2.

- Adequate organ function as indicated by the following laboratory assessments
performed within 14 days prior to the first dose of study drug Hepatic: Serum
bilirubin ≤1.5 times upper limit (X ULN) of normal unless due to leukemic involvement
or Gilbert's syndrome; aspartate aminotransferase or alanine aminotransferase ≤ 2.5 X
ULN; alkaline phosphatase ≤ 2.5 X ULN Renal: Serum creatinine ≤ 1.5 X ULN or 24 hour
creatinine clearance ≥ 50 mL/min

- Female subjects of childbearing potential must have a negative serum or urine
beta-human chorionic gonadotropin pregnancy test within 14 days prior to the start of
study drug

- Sexually active subjects who are fertile must agree to use an effective barrier
method of contraception while on therapy and for 30 days following discontinuation of
study drug. Non-fertile subjects or those not sexually active are also eligible.

- The subject is capable of understanding and complying with the protocol and has
signed the informed consent document.

Exclusion Criteria: Subjects presenting with any of the following will not qualify for
entry into the study:

- Subject has received chemotherapy or a TKI ≤ 7 days, investigational agent ≤ 14 days,
or radiotherapy ≤ 28 days prior to the start of study drug or has not recovered from
the acute toxicities associated with any prior treatments including approved
therapies, investigational agents, and prior stem cell or bone marrow transplant. The
following exceptions apply: i) Hydroxyurea is permitted at any time prior to study
enrollment; ii) Glucocorticoids (natural or synthetic) are allowed up to 48 hours
prior to the start of the study drug (with the exception of steroids for
pre-medication and topical/nasal steroid use which are allowed at any time)

- The subject has AP or BP-CML

- Received immunosuppressive therapy ≤ 28 days prior to the first dose of study drug

- NY Heart Association class III or IV heart disease, active ischemia or any other
uncontrolled cardiac condition such as angina pectoris, clinically significant
cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart
failure

- Myocardial infarction within 3 months of the start of study drug

- Active, uncontrolled systemic infection considered opportunistic, life threatening,
or clinically significant

- Any other severe concurrent disease and/or uncontrolled medical conditions, which in
the judgment of the investigator, could predispose subjects to unacceptable safety
risks or compromise compliance with the protocol

- Human immunodeficiency virus positive

- If female, the subject is pregnant or lactating

- Allergic or hypersensitive to any component of the investigational drug product

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assess the safety and tolerability of the drug

Outcome Time Frame:

Completion of the study

Safety Issue:

Yes

Principal Investigator

Jorge Cortes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

Protocol 2036-01

NCT ID:

NCT00827138

Start Date:

March 2009

Completion Date:

January 2013

Related Keywords:

  • Chronic Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Medical College of WisconsinMilwaukee, Wisconsin  53226
City of HopeDuarte, California  91010
Emory UniversityAtlanta, Georgia  30322
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
University of ChicagoChicago, Illinois  60637
Tufts Medical CenterBoston, Massachusetts  02111
Sidney Kimmel Cancer Center At Johns HopkinsBaltimore, Maryland  21231
The University of Kansas Cancer CenterKansas City, Kansas  66160