Study of Safety and Pharmacokinetics of MK-8242 in Participants With Advanced Solid Tumors (P07650 AM1)
Status: Recruiting
Phase:
Diagnosis: Sarcoma
NCT ID: NCT01463696
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-419
This study is being done to evaluate the safety and pharmacokinetic profile of MK-8242 in participants with advanced solid tumors. In Part 1 of the study, the study drug dose will be escalated to determine the maximum tolerated dose (MTD). In Part 2 of the study, the MTD will be confirmed and the recommended Phase 2 dose (RPTD) established; the effect of MK-8242 on liposarcoma and other tumor types will also be evaluated.
Conducting Institutions:
Dana-Farber Cancer Institute
Overall PI:
Andrew J. Wagner, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Melissa Hohos,
mhohos@partners.org
Dana-Farber Cancer Institute:
Mark Morley,
mmorley@partners.org
Eligibility 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