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

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Merck:

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

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

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:

Poly (ADP-ribose) polymerase (PARP) inhibitor
tumor
cancer

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013