Clinical trial NCT01294735 (phase 1, status: completed)
Conditions: recurrence of solid tumor, glioblastoma multiforme, melanoma
ICD codes: L51.0, L51.8, L51.9, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: mk-4827, temozolomide
SMILES: NC(=O)C1=CC=CC2=CN(N=C12)C1=CC=C(C=C1)[C@@H]1CCCNC1, CSCC[C@H](N)C(O)=O
Eligibility 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.

        OR

          -  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 earlier.

          -  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
             radiotherapy.

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