A Phase 1, First in Human, Single-arm, Open-label Study of Once a Day, Orally Administered BMN 673 in Patients With Advanced or Recurrent Solid Tumors
- Histologically or cytologically documented, unresectable, locally advanced or
metastatic solid tumor
- Must have available archived tumor tissue (formalin-fixed paraffin-embedded) [FFPE].
- 18 years of age or older.
- Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST,
v1.1) or increased CA-125 (ovarian cancer) or PSA (prostate cancer) and/or CA 19-9
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Have adequate organ function
- Able to take oral medications.
- Willing and able to provide informed consent.
- Sexually active patients must be willing to use an acceptable method of
- Females of childbearing potential must have a negative serum pregnancy test at
- Willing and able to comply with all study procedures.
Part 2 Dose Expansion Tumor Types:
- Breast and ovarian cancer patients with deleterious or pathogenic BRCA mutations
who have received no more than 4 prior regimens for metastatic disease.
- Prostate or pancreatic cancer patients with deleterious or pathogenic BRCA mutations
who have received no more than 2 prior regimens for metastatic disease.
- Small cell lung cancer (SCLC) patients who have received no more than one prior
regimen for SCLC.
- Ewing's sarcoma patients who have received no more than 3 prior regimens for
- Part 2 Expansion: Prior treatment with a PARP inhibitor.
- Has history of central nervous system (CNS) metastasis.
* Exception: In patients with SCLC, history of adequately treated brain metastasis
who do not require corticosteroids for management of CNS symptoms.
- Has had major surgery within 28 days before Cycle 1, Day 1.
- Has active peptic ulcer disease.
- Active gastrointestinal tract disease with malabsorption syndrome.
- Pregnant or breastfeeding at screening or planning to become pregnant (in each case,
either oneself or one's partner) at any time during the study.