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A Phase I Study to Evaluate the Safety and Tolerability and Pharmacokinetic/Pharmacodynamics of MK-8242 Administered Alone and in Combination With Chemotherapy in Subjects With Refractory or Recurrent Acute Myelogenous Leukemia (Protocol No. P07649 (005))


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Acute Myelogenous Leukemia (AML)

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Trial Information

A Phase I Study to Evaluate the Safety and Tolerability and Pharmacokinetic/Pharmacodynamics of MK-8242 Administered Alone and in Combination With Chemotherapy in Subjects With Refractory or Recurrent Acute Myelogenous Leukemia (Protocol No. P07649 (005))

Inclusion Criteria


Inclusion criteria:

- For Arm A Part 1 (monotherapy/dose escalation): refractory or recurrent AML, not an
appropriate candidate for standard therapy

- For Arm A Part 2 (monotherapy/dose confirmation/cohort expansion): refractory or
recurrent AML, not an appropriate candidate for standard therapy, and have wild type
TP53 gene mutation analysis

- For Arm B Part 1 (combination therapy/dose escalation): recurrent AML having achieved
an initial CR or CRi of 6-12 months duration and age ≥18 years old and <70 years old

- For Arm B Part 2 (combination therapy/dose confirmation/cohort expansion): recurrent
AML having achieved an initial CR or CRi of 6-12 months duration, age ≥18 years old
and <70 years old, and have wild type TP53 gene mutation analysis

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 for all
Arm A, or 0 or 1 for all Arm B

- Negative pregnancy test within 72 hours of the first dose of study medication

- Female participants and male participants and their partners who are of childbearing
potential must agree to abstain from sexual intercourse or to use an acceptable
method of contraception during the study and for 90 days following the last dose of
study therapy

- Adequate organ function

- Recovered from the effects of any prior surgery, radiotherapy or anti-neoplastic
treatment, with the exception of alopecia

- Must be able to swallow, retain, and absorb oral medications and oral nutrition

- Must follow the appropriate washout period for prohibited treatments

Exclusion criteria:

- Active malignancy other than AML

- Leptomeningeal leukemia requiring intrathecal therapy

- For Arm A and B, Part 1 only: history of myelodysplastic syndrome (MDS)

- For Arm A and B, Part 2: AML in the background of MDS may be included

- Isolated extramedullary leukemia without also meeting bone marrow criteria for acute
leukemia

- AML blast crisis of chronic myelogenous leukemia (CML)

- Bone marrow transplant with active graft-versus host disease (GVHD) or who receives
immunosuppressive therapy

- Uncontrolled active infection that requires systemic treatment

- Clinically significant hepatitis at Screening, or hepatitis C antibody positive,
hepatitis B surface antigen positive, or human immunodeficiency virus (HIV)
seropositive

- Persistent, unresolved, drug-related toxicity

- Breast-feeding, pregnant, intends to become pregnant or intends to breast feed during
the study or has a positive pregnancy test at Screening

- A person participating in any other clinical study with a potentially therapeutic
agent or who has received another investigational product within 5 half-lives (if the
half-life is known) or 28 days (if the half-life is unknown) prior to Day 1 of cycle
1

- A participant who, within the past 6 months, has had any of the following: myocardial
infarction, coronary/peripheral artery bypass graft, cerebrovascular accident,
transient ischemic attack, or uncontrolled seizure disorder (i.e., seizures within
the past 6 months)

- A participant who, at the time of Screening, presents with: unstable or uncontrolled
angina, New York Heart Association (NYHA) class III or IV congestive heart failure,
uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically
significant electrocardiogram (ECG) abnormality

- Known bleeding disorder, e.g. hemophilia or disseminated intravascular coagulopathy
or on anti-coagulation therapy

- For Arm B only: Known hypersensitivity to cytarabine

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of participants with dose limiting toxicities (DLTs)

Outcome Time Frame:

28 days (Cycle 1) for non-hematologic toxicities and 42 days (Cycle 1) for hematologic toxicities

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

P07649

NCT ID:

NCT01451437

Start Date:

November 2011

Completion Date:

October 2016

Related Keywords:

  • Acute Myelogenous Leukemia (AML)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Call for Information (Investigational Site 0002)Houston, Texas  77030
Call for Information (Investigational Site 0006)St. Petersburg, Florida  33701
Call for Information (Investigational Site 0001)Baltimore, Maryland  21287
Call for Information (Investigational Site 0004)Scottsdale, Arizona  85259
Call for Information (Investigational Site 0005)Rochester, Minnesota  55905