Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03025867
Recruitment Status : Approved for marketing
First Posted : January 20, 2017
Last Update Posted : April 17, 2017
Information provided by (Responsible Party):
Tesaro, Inc.

Brief 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.

Condition or disease Intervention/treatment
Recurrent Ovarian Cancer Drug: Niraparib

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)

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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

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, 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

No Contacts or Locations Provided

Responsible Party: Tesaro, Inc. Identifier: NCT03025867     History of Changes
Other Study ID Numbers: 3000-07-001
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017

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