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An Open-Label, Randomized-Sequence, Multicenter, Single-Crossover Study to Assess the Relative Bioavailability of Niraparib Tablet Formulation Compared to Niraparib Capsule Formulation in Patients With Advanced Solid Tumors

Conditions

Anus | Colon | Esophagus | Kidney | Larynx | Lip, Oral Cavity and Pharynx | Liver | Lung | Melanoma, skin | Other Digestive Organ | Other Endocrine System | Other Female Genital | Other Male Genital | Other Respiratory and Intrathoracic Organs | Other Skin | Other Urinary | Ovary | Pancreas | Prostate | Rectum | Small Intestine | Soft Tissue | Stomach | Thyroid | Phase I | Unknown Sites | Breast | Urinary Bladder

Phase I

What is the purpose of this trial?

This is a two stage, open label, randomized-sequence, single-crossover Phase 1 study to evaluate the relative bioavailability (BA) of niraparib administered as a tablet formulation compared to the reference capsule formulation currently marketed in the United States. Specifically, a 300 mg niraparib tablet will be compared to 3 niraparib capsules (3 × 100 mg).The Extension Phase of this study is to enable patients enrolled in the study to continue to receive treatment with niraparib tablets if they are tolerating it and, in the Investigator's opinion, may receive benefit.

  • Trial with
    TESARO, Inc
  • Start Date
    01/29/2019
  • End Date
    05/30/2019
Trial Image

For more information about this study, contact:

Nicole Sinclair

I'm interested in volunteering

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 877.978.8343

  • Last Updated
    01/31/2019
  • Study HIC
    #2000024073