A Phase I Study of MK-4827 for Treatment of Solid Tumors (MK-4827-005)

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01226901
First received: October 21, 2010
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

This study will evaluate whether oral administration of MK-4827 to participants with advanced solid tumors is generally safe and well tolerated.


Condition Intervention Phase
Neoplasms
Solid Tumors
Drug: MK-4827
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 of MK-4827 in Patients With Solid Tumor

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Incidence of dose-limiting toxicities (DLTs) in Cycle 1 [ Time Frame: Cycle 1 of treatment (1 cycle = 21 days) ] [ Designated as safety issue: Yes ]
    Dose-limiting toxicities are defined as all adverse experiences that are clearly not related to disease progression or intercurrent illness. In order to be declared a dose-limiting toxicity, an adverse experience must be related (definitely, probably, or possibly) to study therapy.


Enrollment: 3
Study Start Date: November 2010
Study Completion Date: November 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-4827 once daily
MK-4827
Drug: MK-4827
MK-4287, 150 mg or 300 mg capsule, orally, once daily in 21 day cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must have a histologically or cytologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. There is no limit on the number of prior treatment regimens.
  • Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group(ECOG) Performance Scale
  • Participant must have adequate organ function (per prespecified laboratory values).

Exclusion Criteria:

  • Participant has had major surgery, chemotherapy, radiotherapy, hormonal or biological therapy within 4 weeks (6 weeks for nitrosoureas, mitomycin C, or bevacizumab) prior to entering the study.
  • Participant has known central nervous system metastases or a primary central nervous system tumor.
  • Participant is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study.
  • Participant is known to be Human Immunodeficiency Virus (HIV)-positive.
  • Participant with active Hepatitis B or C.
  • Participant has symptomatic ascites or pleural effusion.
  • Participant has interstitial lung disease as a history or current evidence.
  • Participant has known bleeding tendency or coagulation disorder as a history or current evidence, and/or participant is taking any anti-coagulant and/or antiplatelet therapies.
  • Participant has uncontrolled persistent or active infection (acute infection which requires antibiotic or anti-fungal treatment).
  • Participant has participated in a clinical trial with a known Poly (ADP-ribose) polymerase (PARP) inhibitor.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01226901     History of Changes
Other Study ID Numbers: MK-4827-005
Study First Received: October 21, 2010
Last Updated: June 26, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck Sharp & Dohme Corp.:
Poly (ADP-ribose) polymerase (PARP) inhibitor
tumor
cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 28, 2014