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

Phase 1
18 Years
Not Enrolling
Neoplasms, Solid Tumors

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Incidence of dose-limiting toxicities (DLTs) in Cycle 1

Outcome Description:

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.

Outcome Time Frame:

Cycle 1 of treatment (1 cycle = 21 days)

Safety Issue:



Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

November 2010

Completion Date:

November 2011

Related Keywords:

  • Neoplasms
  • Solid Tumors
  • Poly (ADP-ribose) polymerase (PARP) inhibitor
  • tumor
  • cancer
  • Neoplasms