A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens

NCT02354586 | Completed Phase 2 Results

• 2 other identifiers: 213360PR-30-5020-C
• Study Type: interventional
• Target: 463
• Locations: 2 countries
• Sites: 55

Brief Summary

This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.

Conditions

Ovarian Neoplasms; Ovarian Cancer

Keywords

gBRCAmut; BRCA; PARP inhibitor; HRD; Ovarian cancer; Serous Epithelial; Fallopian Tube; Primary Peritoneal

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  The ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) (version1.1), where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis, PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Primary Analysis Population comprised of participants who received 3 or 4 prior lines of therapy (LOT), had homologous recombination deficiency positive (HRDpos) tumors, had platinum-sensitive disease, and were poly(adenosine 5'-diphosphate \[ADP\]-ribose) polymerase inhibitors (PARPi) naïve.

  Up to 3 years

Secondary Outcomes (6)

• Duration of Response (DoR)

  Up to 3 years

• ORR by HRD Status and Breast Cancer Gene (BRCA) Status

  Up to 3 years

• Disease Control Rate (DCR)

  Up to 3 years

• Progression Free Survival

  Up to 3 years

• Overall Survival

  Up to 3 years

Other Outcomes (6)

• Number of Participants With Any Non-serious Adverse Event (Non-SAE) and Any Serious Adverse Event (SAE)

  Up to a maximum of 71.56 months

• Number of Participants With Abnormality in Hematology Parameters

  Up to 3 years

• Number of Participants With Abnormality in Clinical Chemistry Parameters

  Up to 3 years

Study Arms (1)

Niraparib

EXPERIMENTAL

Drug: Niraparib

Interventions

Niraparib DRUG

Niraparib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must agree to undergo tumor HRD testing and blood gBRCAmut status testing.
• Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
• Patients must have histologically diagnosed high-grade (Grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and experienced a response lasting at least 6 months to first-line platinum based therapy.
• Patients Must have completed 3 or 4 previous chemotherapy regimens.
• Patients must have completed their last chemotherapy regimen \> 4 weeks prior to treatment initiation.
• Patients must have measurable disease according to RECIST (v.1.1).
• Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation.
• Patients must agree to blood samples during screening and at the end of treatment for cytogenetic analysis.

You may not qualify if:

• Patients must not have any known, persistent (\> 4 weeks), ≥Grade 3 hematologic toxicity during the last cancer therapy. Patients must not have any known, persistent (\>4 weeks), ≥ Grade 3 fatigue during the last cancer therapy.
• Patients must not have received pelvic radiotherapy as treatment for primary or recurrent disease within 1 year of the first dose of study treatment.
• Patients must not have symptomatic uncontrolled brain or leptomeningeal metastases.
• Patients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection.
• Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment.
• Patients must not have known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

Sponsors & Collaborators

• Tesaro, Inc.: lead
• Facing Our Risk of Cancer Empowered: collaborator
• Myriad Genetics, Inc.: collaborator

Study Sites (55)

GSK Investigational Site

Chandler, Arizona, 85224, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85016, United States

Location

GSK Investigational Site

Tucson, Arizona, 85710, United States

Location

GSK Investigational Site

Burbank, California, 91505, United States

Location

GSK Investigational Site

Duarte, California, 91010, United States

Location

GSK Investigational Site

Los Angeles, California, 90027, United States

Location

GSK Investigational Site

Los Angeles, California, 90048, United States

Location

GSK Investigational Site

San Francisco, California, 94118, United States

Location

GSK Investigational Site

Santa Barbara, California, 93105, United States

Location

GSK Investigational Site

Stanford, California, 94305-5317, United States

Location

GSK Investigational Site

New Haven, Connecticut, 06510, United States

Location

GSK Investigational Site

Tampa, Florida, 33612, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33401, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30342, United States

Location

GSK Investigational Site

Chicago, Illinois, 60611, United States

Location

GSK Investigational Site

Chicago, Illinois, 60637, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46260, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 54244, United States

Location

GSK Investigational Site

Covington, Louisiana, 70433, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70121, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21202, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02115, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

Burlington, Massachusetts, 01805, United States

Location

GSK Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55455, United States

Location

GSK Investigational Site

Rochester, Minnesota, 55905, United States

Location

GSK Investigational Site

Springfield, Missouri, 65804, United States

Location

GSK Investigational Site

Hackensack, New Jersey, 07601, United States

Location

GSK Investigational Site

Morristown, New Jersey, 07962-1956, United States

Location

GSK Investigational Site

East Setauket, New York, 11733, United States

Location

GSK Investigational Site

Jamaica, New York, 11432, United States

Location

GSK Investigational Site

Lake Success, New York, 11042, United States

Location

GSK Investigational Site

New York, New York, 10065, United States

Location

GSK Investigational Site

Durham, North Carolina, 27710, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73104, United States

Location

GSK Investigational Site

Medford, Oregon, 97504-8342, United States

Location

GSK Investigational Site

Wynnewood, Pennsylvania, 19096, United States

Location

GSK Investigational Site

Providence, Rhode Island, 02905, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

Austin, Texas, 78731, United States

Location

GSK Investigational Site

Dallas, Texas, 75390, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

The Woodlands, Texas, 77380, United States

Location

GSK Investigational Site

Tyler, Texas, 75702, United States

Location

GSK Investigational Site

Spokane, Washington, 99202, United States

Location

GSK Investigational Site

Tacoma, Washington, 98405, United States

Location

GSK Investigational Site

Calgary, Alberta, T2N 4N2, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 2M9, Canada

Location

GSK Investigational Site

Montreal, Quebec, H1T 2M4, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4M1, Canada

Location

GSK Investigational Site

Montreal, Quebec, H3T 1E2, Canada

Location

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (2)

• Moore KN, Secord AA, Geller MA, Miller DS, Cloven N, Fleming GF, Wahner Hendrickson AE, Azodi M, DiSilvestro P, Oza AM, Cristea M, Berek JS, Chan JK, Rimel BJ, Matei DE, Li Y, Sun K, Luptakova K, Matulonis UA, Monk BJ. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2019 May;20(5):636-648. doi: 10.1016/S1470-2045(19)30029-4. Epub 2019 Apr 1.

  PMID: 30948273 BACKGROUND

• Monk BJ, Romero I, Graybill W, Churruca C, O'Malley DM, Knudsen AO, Yap OWS, Baurain JF, Rose PG, Denys H, Ghamande S, Pisano C, Fabbro M, Braicu EI, Calvert PM, Amit A, Prendergast E, Taylor A, Kheibarshekan L, Zhang ZY, Zajic S, Jewell RC, Gupta D, Gonzalez-Martin A. Niraparib Population Pharmacokinetics and Exposure-Response Relationships in Patients With Newly Diagnosed Advanced Ovarian Cancer. Clin Ther. 2024 Aug;46(8):612-621. doi: 10.1016/j.clinthera.2024.06.001. Epub 2024 Jul 16.

  PMID: 39019698 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: February 3, 2015
• Study Start: March 23, 2015
• Primary Completion: February 28, 2018
• Study Completion: August 23, 2021
• Last Updated: September 15, 2022
• Results First Posted: April 9, 2020

Record last verified: 2022-07

Locations

CA (7); US (48)