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Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

This treatment has been approved for sale to the public.
Sponsor:
Information provided by (Responsible Party):
Tesaro, Inc.
ClinicalTrials.gov Identifier:
NCT03025867
First received: January 16, 2017
Last updated: April 13, 2017
Last verified: April 2017
  Purpose

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.


Condition Intervention
Recurrent Ovarian Cancer
Drug: Niraparib

Study Type: Expanded Access     What is Expanded Access?
Official Title: Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Tesaro, Inc.:

Detailed 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)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

  1. Histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
  2. Completion of at least 2 previous courses of platinum-containing chemotherapy.
  3. Had a CR or PR with duration of response >/=6 months following penultimate chemotherapy
  4. Achieved a partial (PR) or complete (CR) tumor response following completion of the last platinum-containing chemotherapy [minimum of 4 cycles]
  5. Patients previously treated with PARP inhibitors are eligible
  6. Eastern Cooperative Oncology Group (ECOG, http://ecog-acrin.org/) performance status 0 or 1
  7. Adequate organ function [Absolute neutrophil count (ANC) ≥ (greater than or equal to) 1,500/µL; Platelets ≥ (greater than or equal to) 100,000/µL; Hemoglobin ≥ (greater than or equal to) 9 g/dL]
  8. Able to take oral medications
  9. Women should not be pregnant at the beginning of the treatment and women or childbearing potential should not become pregnant while on niraparib
  10. Patient should start treatment with niraparib no later than 12 weeks after completion of final dose of the platinum-containing chemotherapy

Exclusion Criteria:

  1. Persistent ≥Grade 2 hematologic toxicity from prior cancer therapy
  2. Known hypersensitivity to the components of niraparib
  3. Patient is pregnant or breast feeding, or expecting to conceive children within the projected duration of the program treatment
  4. Patient has uncontrolled hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT03025867     History of Changes
Other Study ID Numbers: 3000-07-001
Study First Received: January 16, 2017
Last Updated: April 13, 2017

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 25, 2017