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

NCT01226901 | Terminated Phase 1 DMC

• 1 other identifier: MK-4827-005
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Neoplasms; Solid Tumors

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

MK-4827 once daily

EXPERIMENTAL

MK-4827

Drug: MK-4827

Interventions

MK-4827 DRUG

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

MK-4827 once daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Neoplasms

Interventions

niraparib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 22, 2010
• Study Start: November 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 28, 2012

Record last verified: 2012-06