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Trial record 1 of 1 for:    NCT01286987
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Study of BMN 673, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
BioMarin Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01286987
First received: January 26, 2011
Last updated: October 7, 2014
Last verified: October 2014

January 26, 2011
October 7, 2014
December 2010
December 2014   (final data collection date for primary outcome measure)
The primary outcome of this study is to determine the maximum tolerated dose (MTD) of daily oral BMN 673 [ Time Frame: Assessed after each visit until completion of Part 1 (Estimated duration is 12-18 months) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01286987 on ClinicalTrials.gov Archive Site
  • Number of participants with adverse events [ Time Frame: Assessed after each visit until completion of the study (Estimated duration is 24-30 months) ] [ Designated as safety issue: Yes ]
  • Determine the pharmacokinetic (PK) profile of BMN 673 [ Time Frame: Assessed at each visit in cycle 1 - 5 (Estimated duration is 24 months) ] [ Designated as safety issue: No ]
    Sample collection times vary per visit. PK parameters that will be evaluated include: maximum concentration (Cmax), minimum concentration (Cmin), time to maximum plasma concentration (Tmax), area under the curve from 0 to last quantifiable sampling point post-dose (AUC0-inf), are under the curve extrapolated to infinity (AUC0-last), half life (t1/2), systemic clearance (CL/f) and volume of distribution (VZ/f)
  • Determine the Recommended Phase 2 Dose (RP2D) of oral daily BMN 673 [ Time Frame: Assessed after each visit until completion of the study (Estimated duration is 24-30 months) ] [ Designated as safety issue: No ]
  • Assess preliminary efficacy of BMN 673 by Response Rate, based on RECIST (Response Evaluation Criteria In Solid Tumors) [ Time Frame: Assessed approximately every 8 weeks (Estimated duration is 24-30 months) ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: Assessed after each visit until completion of the study (Estimated duration is 24-30 months) ] [ Designated as safety issue: Yes ]
  • Determine the pharmacokinetic (PK) profile of BMN 673 [ Time Frame: Assessed at each visit in cycle 1 - 5 (Estimated duration is 24 months) ] [ Designated as safety issue: No ]
    Sample collection times vary per visit. PK parameters that will be evaluated include: maximum concentration (Cmax), minimum concentration (Cmin), time to maximum plasma concentration (Tmax), area under the curve from 0 to last quantifiable sampling point postdose (AUC0-inf), are under the curve extrapolated to infinity (AUC0-last), half life (t1/2), systemic clearance (CL/f) and volume of ditribution (VZ/f)
  • Determine the Recommended Phase 2 Dose (RP2D) of oral daily BMN 673 [ Time Frame: Assessed after each visit until completion of the study (Estimated duration is 24-30 months) ] [ Designated as safety issue: No ]
  • Assess preliminary efficacy of BMN 673 by Response Rate, based on RECIST (Response Evaluation Criteria In Solid Tumors) [ Time Frame: Assessed approximately every 8 weeks (Estimated duration is 24-30 months) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of BMN 673, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
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

This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BMN 673 in patients with advanced tumors with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced or Recurrent Solid Tumors
  • Breast Neoplasms
  • Ovarian Cancer, Epithelial
  • Ewing Sarcoma
  • Small Cell Lung Carcinoma
  • Prostate Cancer
  • Pancreas Cancer
Drug: BMN 673
Oral capsule with multiple dosage forms given once daily
Experimental: BMN 673
Intervention: Drug: BMN 673
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
85
Not Provided
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT01286987
PRP-001
Not Provided
BioMarin Pharmaceutical
BioMarin Pharmaceutical
Not Provided
Study Director: Gilles Gallant BioMarin Pharmaceutical
BioMarin Pharmaceutical
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP