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

Neoplasms Clinical Trial

Official title:

A Phase I Study of MK-4827 in Patients With Solid Tumor

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01226901
• Other study ID #: MK-4827-005
• Status: Terminated
• Phase: Phase 1
• First received: October 21, 2010
• Last updated: June 26, 2012
• Start date: November 2010
• Est. completion date: November 2011

Study information

• Verified date: June 2012
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• MK-4827
MK-4287, 150 mg or 300 mg capsule, orally, once daily in 21 day cycles.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicities (DLTs) in Cycle 1	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.	Cycle 1 of treatment (1 cycle = 21 days)	Yes