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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced or Recurrent Solid Tumors, Breast Neoplasms, Ovarian Cancer, Epithelial, Ewing Sarcoma, Small Cell Lung Carcinoma, Prostate Cancer, Pancreas Cancer

Thank you

Trial Information

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


Inclusion Criteria:



- 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
(pancreatic cancer).

- 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
contraception.

- Females of childbearing potential must have a negative serum pregnancy test at
screening.

- 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
metastatic disease.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary outcome of this study is to determine the maximum tolerated dose (MTD) of daily oral BMN 673

Outcome Time Frame:

Assessed after each visit until completion of Part 1 (Estimated duration is 12-18 months)

Safety Issue:

Yes

Principal Investigator

Andrew Dorr, MD

Investigator Role:

Study Director

Investigator Affiliation:

BioMarin Pharmaceutical

Authority:

United States: Food and Drug Administration

Study ID:

PRP-001

NCT ID:

NCT01286987

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Advanced or Recurrent Solid Tumors
  • Breast Neoplasms
  • Ovarian Cancer, Epithelial
  • Ewing Sarcoma
  • Small Cell Lung Carcinoma
  • Prostate Cancer
  • Pancreas Cancer
  • BRCA1 Protein
  • BRCA2 Protein
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma
  • Lung Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Prostatic Neoplasms
  • Small Cell Lung Carcinoma
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Neoplasms, Glandular and Epithelial
  • Sarcoma

Name

Location

University of Texas MD Anderson Cancer CenterHouston, Texas  77030
University of Michigan Health SystemAnn Arbor, Michigan  
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
TGen Clinical Research ServicesScottsdale, Arizona  85258
University of California Los Angeles (UCLA)Los Angeles, California  90095