Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of Niraparib in Japanese patients with advanced solid tumors.


Clinical Trial Description

The drug being tested in this study is called Niraparib. Niraparib is being tested to treat Japanese patients with advanced solid tumors. This study will look at the safety, tolerability and pharmacokinetics of Niraparib administered once daily orally.

The study will enroll approximately 12 patients as a maximum. Participants will be assigned to Cohort 1 (21-day treatment cycle). After that, participants will be assigned to Cohort 2 when safety and tolerability of the 200 mg dose will be demonstrated.

This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 16 months. Participants will make multiple visits to the clinic with final visit approximately 28 days after last dose of study drug for a follow-up assessment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03497429
Study type Interventional
Source Takeda
Contact Takeda Study Registration Call Center
Phone +1-877-825-3327
Email medicalinformation@tpna.com
Status Recruiting
Phase Phase 1
Start date April 5, 2018
Completion date August 31, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT03260322 - A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT02253992 - An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma Phase 1/Phase 2
Completed NCT03070548 - A Study of Talazoparib in Patients With Advanced Solid Tumors Phase 1
Completed NCT01830816 - Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Patients With Normal Renal Function or Severe Renal Impairment Phase 1
Active, not recruiting NCT02565758 - ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors Phase 1
Recruiting NCT02926768 - Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT02448589 - An Investigation of TAS-119 Monotherapy and in Combination With Docetaxel Phase 1
Completed NCT02214147 - Pharmacokinetics of Alisertib in Adults With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function Phase 1
Terminated NCT01668017 - A Multicentre, Open Label, Phase 1 Trial in Japan of the Mitogen Activated Protein Extracellular Signal Regulated Kinase (MEK) Inhibitor Pimasertib Given Orally to Subjects With Solid Tumors as Monotherapy Phase 1
Terminated NCT01497626 - Lapatinib and Bortezomib in Patients With Advanced Malignancies Phase 1
Completed NCT01094288 - A Phase 1 Study of MLN8237 in Patients With Advanced Solid Tumors Including Castration-Resistant Prostate Cancer Receiving a Standard Docetaxel Regimen Phase 1
Recruiting NCT01226030 - Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors Phase 1
Completed NCT00963547 - A Study of MK2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (2206-015) Phase 1
Completed NCT00962091 - Study of MLN8237 in Patients With Advanced Solid Tumors Phase 1
Completed NCT00827177 - Dose Escalation Study of ARQ 197 in Combination With Sorafenib in Adult Patients With Advanced Solid Tumors Phase 1
Completed NCT01005355 - Study of IMC-1121B in Patients With Advanced Solid Tumors Phase 1
Terminated NCT00932126 - This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid Tumors Phase 1
Terminated NCT00729833 - Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors Phase 1
Withdrawn NCT00682279 - A Phase I Study Of Oral Topotecan And Lapatinib In Subjects With Advanced Solid Tumors Phase 1
Completed NCT00947739 - Phase I and Pharmacology Study of Camptothecin-20-O-Propionate Hydrate (CZ48) in Patients With Solid Tumors or Lymphoma Phase 1