Clinical Trials Logo

Clinical Trial Summary

This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer.

This program is designed to provide access to niraparib prior to approval by the US Food and Drug Administration (FDA).

To be eligible, patients with Recurrent Ovarian Cancer following a partial (PR) or complete response (CR) to their most recent platinum-based chemotherapy and must have experienced a PR or CR after the penultimate (next to last) platinum-based chemotherapy for at least 6 months without disease progression after this chemotherapy.


Clinical Trial Description

If a patient qualifies for participation in an ongoing niraparib clinical trial or is already participating in a niraparib clinical trial, she will not be able to participate in the EAP.

Ongoing clinical trials for niraparib include:

- A Phase 3 trial in patients who have received first-line treatment for ovarian cancer (the PRIMA trial, NCT # 02655016)

- A Phase 2 trial in patients who have received multiple lines of treatment for ovarian cancer (the QUADRA trial, NCT # 02354586)

- A Phase 1/2 trial in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. (the TOPACIO trial, NCT # 02657889) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03025867
Study type Expanded Access
Source Tesaro, Inc.
Contact
Status Approved for marketing
Phase N/A

See also
  Status Clinical Trial Phase
Completed NCT02195973 - Phase IB Trial of LDE225 and Paclitaxel in Recurrent Ovarian Cancer Phase 1
Not yet recruiting NCT05270720 - Dendritic Cell Vaccination With Standard Postoperative Chemotherapy for the Treatment of Adult Ovarian Cancer Phase 1
Not yet recruiting NCT06070285 - Investigating Participation Patterns Among Recurrent Ovarian Cancer Patients
Completed NCT02303912 - Safety and Efficacy Study of Nuc-1031 and Carboplatin Combination to Treat Recurrent Ovarian Cancer Phase 1
Active, not recruiting NCT01802749 - Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer Phase 3
Completed NCT02788708 - Lenvatinib and Weekly Paclitaxel for Patients With Recurrent Endometrial or Ovarian Cancer Phase 1
Recruiting NCT03564340 - Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers Phase 1/Phase 2
Recruiting NCT05610735 - Combination Therapy for Recurrent Ovarian Cancer Phase 1/Phase 2
Withdrawn NCT02083536 - LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma Phase 1
Completed NCT03430518 - Durvalumab and Eribulin in Her2-negative Metastatic Breast Cancer and Recurrent Ovarian Cancer Phase 1
Recruiting NCT03618706 - Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer Phase 2
Recruiting NCT05311579 - Niraparib Plus Anlotinib for Recurrent Ovarian Cancer Phase 2
Active, not recruiting NCT01851746 - A Study of Docetaxel and Lobaplatin Versus Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian Cancer N/A
Active, not recruiting NCT06107868 - Phase 1 Study of RP-6306 With Carboplatin and Paclitaxel in TP53 Ovarian and Uterine Cancer Phase 1
Recruiting NCT06308406 - A Phase Ib/II Clinical Study of HRS-1167 in Combination With Bevacizumab in Patients With Recurrent Ovarian Cancer Phase 1/Phase 2
Not yet recruiting NCT06365853 - A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression Phase 2
Completed NCT04718740 - A Drug-drug Interaction Study Of Fluzoparib (SHR3162) on Patients With Recurrent Ovarian Cancer Phase 1
Active, not recruiting NCT05335993 - A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer. Phase 2
Completed NCT01381861 - Evaluation of TRC105 in the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma Phase 2
Not yet recruiting NCT05126342 - Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi Phase 2