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A Phase I Study of MK-4827 in Combination With Temozolomide in Patients With Advanced Cancer

Phase 1
18 Years
Not Enrolling
Recurrence of Solid Tumor, Glioblastoma Multiforme, Melanoma

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Trial Information

A Phase I Study of MK-4827 in Combination With Temozolomide in Patients With Advanced Cancer

Inclusion Criteria

Inclusion criteria

Part A

- Participants with histologically-confirmed advanced solid tumors who have failed to
respond to standard therapy, or progressed on standard therapy, or for whom standard
therapy does not exist.

Part B

- Participants must have a histologically-confirmed recurrent glioblastoma multiforme
(GBM) with radiographic evidence of progression/recurrence of disease, with up to two
prior treatment regimens (not including temozolomide or bevacizumab) for their
recurrent disease.


- Participants must have histologically-confirmed recurrent or metastatic melanoma for
which the participant has received up to two prior therapies.

- Participants must not have received prior treatment with cytotoxic chemotherapy
including temozolomide, dacarbazine, or PARP inhibitors.

Part A and Part B

- Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0
or 1.

- Participants must have adequate organ function.

- Women of childbearing potential and male participants must agree to use an adequate
method of contraception starting with the first dose of study drug through 90 days
after the last dose of study drugs.

- Participant has no history of a prior malignancy with the exception of gliomas (as
secondary GBM is allowed), cervical intraepithelial neoplasia, basal cell carcinoma
of the skin, or adequately treated localized prostate carcinoma with
Prostate-Specific Antigen (PSA) < 1.0; or who has undergone potentially curative
therapy with no evidence of that disease for five years, or who is deemed at low risk
for recurrence by his/her treating physician.

- Participant has at least one measurable metastatic or recurrent lesion.

Exclusion criteria

- Participant has had chemotherapy, radiotherapy, or biological therapy within four
weeks prior to study Day 1 (six weeks for nitrosoureas and mitomycin C) or who has
not recovered from adverse events due to agents administered more than four weeks

- Participants with known symptomatic or progressive Central Nervous System (CNS)
metastases and/or carcinomatous meningitis.

- Participant has prior exposure to PARP inhibitors. Prior exposure to temozolomide is
allowed only for participants with GBM, provided it was received in the adjuvant
setting with GBM progression after completion of adjuvant temozolomide treatment and
a treatment-free interval of ≥ 3 months.

- Participant has significant or uncontrolled cardiovascular disease, including New
York Heart Association (NYHA) Class III-IV heart failure, unstable angina, or a
myocardial infarction within the last six months.

- Participant is breastfeeding.

- Participant is known to be Human Immunodeficiency Virus (HIV)-positive.

- Participant has active Hepatitis B or C.

- Participant has symptomatic ascites or pleural effusion.

- Participant has a requirement for concurrent treatment with immunosuppressive agents.

- Participant must not have prior radiation therapy to more than 30% of hte bone marrow
and must have recovered for at least 3 weeks from the hematologic toxicity of prior

- Participant has had a prior stem cell or bone marrow transplant.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with DLTs

Outcome Time Frame:

Cycle 1 (28 days)

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2011

Completion Date:

May 2012

Related Keywords:

  • Recurrence of Solid Tumor
  • Glioblastoma Multiforme
  • Melanoma
  • Temozolomide
  • glioblastoma multiforme
  • melanoma
  • advanced neoplasm
  • Glioblastoma
  • Melanoma
  • Recurrence