Study of Safety and Pharmacokinetics of MK-8242 in Participants With Advanced Solid Tumors (P07650 AM1)
This study is currently recruiting participants.
Verified March 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01463696
First received: October 28, 2011
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: MK-8242 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study to Evaluate the Safety and Tolerability and Pharmacokinetic/Pharmacodynamics of MK-8242 in Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Cycle 1 (21 days) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Maximum observed plasma concentration (Cmax) of MK-8242 [ Time Frame: Cycle 1, Day 1 pre-dose and through 24 hours post dose; Cycle 1 Day 7 pre-dose and through 48 hours post dose ] [ Designated as safety issue: No ]
- Time to maximum plasma concentration (Tmax) of MK-8242 [ Time Frame: Cycle 1, Day 1 pre-dose and through 12 hours postdose; Cycle 1 Day 7 pre-dose and through 48 hours post dose ] [ Designated as safety issue: No ]
- Area under the concentration time curve from Hour 0 to Hour 12 (AUC0-12) for MK-8242 [ Time Frame: Cycle 1, Day 1 and Day 7, Hour 0 through Hour 12 ] [ Designated as safety issue: No ]
- AUC from time 0 to the time of final quantifiable sample (AUCtf) for MK-8242 [ Time Frame: Cycle 1, Day 1 pre-dose and through 12 hours post dose; Cycle 1 Day 7 pre-dose and through 48 hours post dose ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 132 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Part 1: MK-8242 dose escalation |
Drug: MK-8242
MK-8242 capsules will be administered orally twice a day (BID) in Cycle1 and once in the morning (QD) on Day 7 of a 21-day cycle to accommodate pharmacokinetic (PK) sampling. In Cycle 2 and subsequent cycles, MK-8242 will be administered orally twice a day (BID) on Days 1-7 in a 21-day cycle.
Other Name: SCH 900242
|
| Experimental: Part 2: MK-8242 dose confirmation |
Drug: MK-8242
MK-8242 capsules will be administered orally twice a day (BID) in Cycle1 and once in the morning (QD) on Day 7 of a 21-day cycle to accommodate pharmacokinetic (PK) sampling. In Cycle 2 and subsequent cycles, MK-8242 will be administered orally twice a day (BID) on Days 1-7 in a 21-day cycle.
Other Name: SCH 900242
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463696
Contacts
| Contact: Toll Free Number | 1-888-577-8839 |
Locations
| United States, Florida | |
| Call for Information (Investigational Site 0004) | Recruiting |
| Tampa, Florida, United States, 33612 | |
| United States, Massachusetts | |
| Call for Information (Investigational Site 0002) | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| United States, Texas | |
| Call for Information (Investigational Site 0003) | Recruiting |
| Houston, Texas, United States, 77030 | |
| United Kingdom | |
| Merck Sharp & Dohme Ltd. | Recruiting |
| Hoddesdon, United Kingdom | |
| Contact: Paul Robinson 44 1992452396 | |
Sponsors and Collaborators
Merck
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01463696 History of Changes |
| Other Study ID Numbers: | P07650, 2011-001346-15 |
| Study First Received: | October 28, 2011 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013