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A Phase I Study to Evaluate the Safety and Tolerability and Pharmacokinetic/Pharmacodynamics of MK-8242 in Patients With Advanced Solid Tumors


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

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Trial Information

A Phase I Study to Evaluate the Safety and Tolerability and Pharmacokinetic/Pharmacodynamics of MK-8242 in Patients With Advanced Solid Tumors

Inclusion Criteria


Inclusion criteria:

- Histologically confirmed advanced solid tumor for which there are no effective
standard therapy options

- Willing to provide tumor tissue for p53 wild type gene analysis Eastern Cooperative
Oncology Group (ECOG) performance status of ≤1

- Adequate organ function

- 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

- At least one measurable lesion

- In Part 2, participants with liposarcoma must have a confirmed well-differentiated or
de-differentiated histology

Exclusion criteria:

- Known treated or untreated leptomeningeal metastases, or metastatic central nervous
system disease

- History of recent myocardial infarction (within the past year); or 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

- Uncontrolled active infection on optimal systemic treatment

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

- Persistent, unresolved common terminology criteria for adverse events (CTCAE v4.0)
≥Grade 2 drug-related toxicity associated with previous treatment except for alopecia

- Radiation therapy or other loco-regional therapy within 2 weeks prior to study

- Use of moderate and strong Cytochrome P450 inhibitors or inducers within 1 week prior
to study

- Chemotherapy or any investigational drug(s) within 4 weeks prior to study

- Known hypersensitivity to MK-8242 or its components

- Nursing, pregnant, or intention to become pregnant during the study

- Initiating bisphosphonate therapy or adjusting the bisphosphonate dose or regimen
within 30 days of Cycle 1 Day 1

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of participants with dose limiting toxicities (DLTs)

Outcome Time Frame:

Cycle 1 (21 days)

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

P07650

NCT ID:

NCT01463696

Start Date:

December 2011

Completion Date:

August 2015

Related Keywords:

  • Solid Tumors
  • Neoplasms

Name

Location

Call for Information (Investigational Site 0004)Tampa, Florida  33612
Call for Information (Investigational Site 0002)Boston, Massachusetts  02215
Call for Information (Investigational Site 0003)Houston, Texas  77030