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Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT03330405
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).

Condition or disease Intervention/treatment Phase
Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors Drug: Avelumab Phase 1b Drug: Talazoparib Phase 1b Drug: Avelumab Phase 2 Drug: Talazoparib Phase 2 Phase 2

Detailed Description:

Avelumab is a human immunoglobulin (Ig)G1 monoclonal antibody (mAb) directed against programmed death ligand 1 (PD L1). Avelumab selectively binds to PD L1 and competitively blocks its interaction with programmed death receptor 1 (PD 1), thereby interfering with this key immune checkpoint inhibition pathway. Avelumab is currently being investigated as single agent and in combination with other anti cancer therapies in patients with locally advanced or metastatic solid tumors and various hematological malignancies.

Talazoparib is a potent, orally bioavailable poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor, which is cytotoxic to human cancer cell lines harboring gene mutations that compromise deoxyribonucleic acid (DNA) repair, an effect referred to as synthetic lethality, and by trapping PARP protein on DNA thereby preventing DNA repair, replication, and transcription.

Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 1B/2 STUDY TO EVALUATE SAFETY AND ANTI TUMOR ACTIVITY OF AVELUMAB IN COMBINATION WITH THE POLY(ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : March 28, 2020
Estimated Study Completion Date : March 28, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Avelumab

Arm Intervention/treatment
Experimental: Dose Level 0 Phase 1b

Drug: Avelumab

Drug: Talazoparib

Drug: Avelumab Phase 1b
Avelumab
Other Name: MSB0010718C

Drug: Talazoparib Phase 1b
Talazoparib
Other Name: MDV3800, BMN 673

Experimental: Dose Level -1 Phase 1b

Drug: Avelumab

Drug: Talazoparib

Drug: Avelumab Phase 1b
Avelumab
Other Name: MSB0010718C

Drug: Talazoparib Phase 1b
Talazoparib
Other Name: MDV3800, BMN 673

Experimental: Dose Level -2 Phase 1b

Drug: Avelumab

Drug: Talazoparib

Drug: Avelumab Phase 1b
Avelumab
Other Name: MSB0010718C

Drug: Talazoparib Phase 1b
Talazoparib
Other Name: MDV3800, BMN 673

Experimental: A1. NSCLC Phase 2

Drug: Avelumab

Drug: Talazoparib

Drug: Avelumab Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MSB0010718C

Drug: Talazoparib Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MDV3800, BMN 673

Experimental: A2. NSCLC PD-L1 Resistant DDR+ Phase 2

Drug: Avelumab

Drug: Talazoparib

Drug: Avelumab Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MSB0010718C

Drug: Talazoparib Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MDV3800, BMN 673

Experimental: B1. TNBC Phase 2

Drug: Avelumab

Drug: Talazoparib

Drug: Avelumab Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MSB0010718C

Drug: Talazoparib Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MDV3800, BMN 673

Experimental: B2. HR+BC DDR Defect +Assay Phase 2

Drug: Avelumab

Drug: Talazoparib

Drug: Avelumab Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MSB0010718C

Drug: Talazoparib Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MDV3800, BMN 673

Experimental: C1. Ovarian CA Recurrent Plat-Sensitive Phase 2

Drug: Avelumab

Drug: Talazoparib

Drug: Avelumab Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MSB0010718C

Drug: Talazoparib Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MDV3800, BMN 673

Experimental: C2.Ovarian CA Recurrent Plat-Sensitive BRCA defect Phase 2

Drug: Avelumab

Drug: Talazoparib

Drug: Avelumab Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MSB0010718C

Drug: Talazoparib Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MDV3800, BMN 673

Experimental: D.Urothelial CA Phase 2

Drug: Avelumab

Drug: Talazoparib

Drug: Avelumab Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MSB0010718C

Drug: Talazoparib Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MDV3800, BMN 673

Experimental: E1. CRPC Phase 2

Drug: Avelumab

Drug: Talazoparib

Drug: Avelumab Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MSB0010718C

Drug: Talazoparib Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MDV3800, BMN 673

Experimental: E2. CRPC DDR Defect +Assay Phase 2

Drug: Avelumab

Drug: Talazoparib

Drug: Avelumab Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MSB0010718C

Drug: Talazoparib Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MDV3800, BMN 673

Experimental: F: Advanced Solid Tumors with BRCA or ATM defect Phase 2

Drug: Avelumab

Drug: Talazoparib

Drug: Avelumab Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MSB0010718C

Drug: Talazoparib Phase 2
The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
Other Name: MDV3800, BMN 673




Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: Cycle 1 Days 1-28 (28 days from date of first dose of study treatment) ]
    Phase 1b: DLT during the DLT evaluation period (Cycle 1)

  2. Overall Response (OR) [ Time Frame: From date of first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to approximately 24 months ]
    Phase 2: Confirmed OR, as assessed by the Investigator using RECIST v1.1 in patients with locally advanced or metastatic solid tumors and RECIST v1.1 and PCWG3 in patients with metastatic CRPC


Secondary Outcome Measures :
  1. Serum concentrations of avelumab [ Time Frame: Day 1 Cycles 1-4, 6, 9, 12, 18, 24 and Day 15 Cycle 1 ]
    Pharmacokinetic parameters: pre-dose/trough concentrations (Ctrough)

  2. Anti drug antibody (ADA) levels of avelumab [ Time Frame: Day 1 Cycles 1-4, 6,9,12,18, 24 and Day 15 Cycle 1 ]
    Immunogenicity assessment of avelumab

  3. OR [ Time Frame: From the start of treatment until disease progression/recurrence up to approximately 24 months ]
    Phase 1b: Confirmed OR, as assessed by the Investigator using RECIST v1.1 in patients with locally advanced or metastatic solid tumors and RECIST v1.1 and PCWG3 in patients with metastatic CRPC.

  4. PSA Tumor Marker [ Time Frame: Baseline, Day1 of each cycle (each cycle is 28 days), and End of Treatment ( up to approximately 24 months) ]
    PSA response greater than or equal to 50% for patients with metastatic CRPC.

  5. CA-125 Tumor Marker [ Time Frame: Baseline, Day1 of each cycle (each cycle is 28 days), and End of Treatment (up to approximately 24 months) ]
    CA-125 response for patients with ovarian cancer.

  6. Biomarker PD-L1 [ Time Frame: Baseline ]
    PD-L1 expression level in baseline tumor tissue.

  7. Genomic [ Time Frame: Baseline ]
    Genomic scarring and the presence of defects in select genes, considered critical to effective DDR, in baseline tumor tissue.

  8. Serum concentrations of avelumab [ Time Frame: Day 1 Cycles 1-4, 6,9,12,18, 24 and Day 15 Cycle 1 ]
    Pharmacokinetic parameters: maximum concentrations (Cmax)

  9. Plasma concentrations of talazoparib [ Time Frame: Day 1 Cycles 1-4 and Day 15 Cycle 1 ]
    Pharmacokinetic parameters: pre-dose/trough concentrations (Ctrough)

  10. Plasma concentration of talazoparib [ Time Frame: Day 1 Cycles 1-4 and Day 15 Cycle 1 ]
    Pharmacokinetic parameters: post-dose concentrations

  11. Neutralizing antibodies (Nab) levels against avelumab. [ Time Frame: Day 1 Cycles 1-4, 6, 9, 12, 18, 24 and Day 15 Cycle 1 ]
    Immunogenicity assessment of avelumab

  12. Time to Tumor Response (TTR) [ Time Frame: Baseline up to approximately 24 months ]
    Time to Tumor Response (TTR) is defined for patients with confirmed objective response (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response.

  13. Duration of response (DR) [ Time Frame: Baseline up to approximately 24 months ]
    Duration of Response (DR) is defined for patients with confirmed objective response (complete response [CR] or partial response [PR]) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

  14. Progression-Free Survival (PFS) [ Time Frame: Baseline up to approximately 24 months ]
    Progression Free Survival (PFS) is defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurs first.

  15. Prostate-Specific Antigen (PSA) response [ Time Frame: Baseline up to approximately 24 months ]
    PSA response is defined as the proportion of patients with confirmed PSA decline greater than or equal to 50% compared to baseline.

  16. Overall Survival (OS) [ Time Frame: Baseline up to approximately 24 months ]
    OS is defined as the time from the first dose of study treatment to the date of death.

  17. Biomarker Tumor Mutational Burden [ Time Frame: Baseline ]
    Tumor mutational burden in baseline tumor tissue



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent in adult patients with: NSCLC, TNBC, HR+ breast cancer, recurrent platinum sensitive ovarian cancer, UC, CRPC, and other advanced solid tumors with a BRCA or ATM gene defect
  • Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor biopsy during the screening period.
  • Minimum age in Japan is 20 years.
  • ECOG performance status 0 or 1.
  • Resolved acute effects of prior therapy
  • Adequate bone marrow, renal, and liver function.
  • Negative serum pregnancy test at screening.
  • Pregnant, breastfeeding females or female patients able to have children must agree to use highly effective method of contraception throughout the study and for at least 30 days after the last dose of avelumab and for at least 7 months after the last dose of talazoparib; fertile male patients must use a condom during treatment and for at least 4 months after the last dose of talazoparib.
  • Signed and dated informed consent.

Exclusion Criteria:

  • Prior treatment with a PARP inhibitor.
  • Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, OX 40, GITR, LAG 3, IDO, TDO,TIM 3, CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. Prior treatment with Sipuleucel-T for patients with mCRPC is allowed. For cohort A2 NSCLC patients prior treatment with anti-PD-1/L1 is allowed
  • Prior anti-cancer therapy within 2 weeks prior to study enrollment. Prior radiation therapy within 2 weeks prior to enrollment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed 2 days prior to study enrollment and no clinically significant toxicities are expected (eg, mucositis, esophagitis).
  • Major surgery within 4 weeks prior to study enrollment.
  • Current use of immunosuppressive medication at the time of study enrollment.
  • Known prior or suspected hypersensitivity to investigational products.
  • Known history of immune mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
  • Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
  • Prior organ transplantation including allogenic stem-cell transplantation.
  • Vaccination within 4 weeks of study enrollment and while on trial is prohibited except for administration of inactivated vaccines.
  • Diagnosis of Myelodysplastic Syndrome.
  • Patients with known brain metastases requiring steroids.
  • Participation in other studies involving investigational drug(s) within 4 weeks prior to study participation and/or during study participation.
  • Persisting toxicity related to prior therapy >Grade 1
  • Known HIV or AIDs-related illness.
  • Positive HBV or HCV test indicating acute or chronic infection.
  • Active infection requiring systemic therapy.
  • Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study entry; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
  • Current or anticipated use within 7 days prior to first dose of study drug, or anticipated use during the study of a strong P-gp inhibitor.
  • Other acute or chronic medical or psychiatric conditions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330405


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Hide Study Locations
Locations
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United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
Highlands Oncology Group Recruiting
Rogers, Arkansas, United States, 72758
United States, California
Tower Hematology Oncology Medical Group Not yet recruiting
Beverly Hills, California, United States, 90211
Keck Hospital of USC Recruiting
Los Angeles, California, United States, 90033
LAC+USC Medical Center Recruiting
Los Angeles, California, United States, 90033
USC/Norris Comprehensive Cancer Center/Investigational Drug Services Recruiting
Los Angeles, California, United States, 90033
USC/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92663
Freidenrich Center for Translational Research (CTRU) Recruiting
Palo Alto, California, United States, 94304
Stanford Cancer Institute Recruiting
Stanford, California, United States, 94305
Stanford Hospital and Clinics Recruiting
Stanford, California, United States, 94305
Stanford Women's Cancer Center Recruiting
Stanford, California, United States, 94305
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
United States, Massachusetts
Massachusetts General Hospital (MGH) Recruiting
Boston, Massachusetts, United States, 02114
Massachusetts General Hospital Attn: Svetlana Rashkova Recruiting
Boston, Massachusetts, United States, 02114
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute, Attn: Vasilika Koci, PharmD Recruiting
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute Not yet recruiting
Detroit, Michigan, United States, 48201
Karmanos Cancer Institute Weisberg Cancer Treatment Center Not yet recruiting
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
University Of Minesota Health: Clinics And Surgery Center Recruiting
Minneapolis, Minnesota, United States, 55455
University of Minesota Medical Center, Fairview IDS Pharmacy Recruiting
Minneapolis, Minnesota, United States, 55455
University of Minnesota Medical Center, Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
United States, New York
Roswell Park Cancer Center Institute Recruiting
Buffalo, New York, United States, 14263
NYU Investigational Pharmacy Recruiting
New York, New York, United States, 10016
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
NYU Laura and Isaac Perlmutter Cancer Center Recruiting
New York, New York, United States, 10016
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Mount Sinai Hospital- Pharmacy department Recruiting
New York, New York, United States, 10029
United States, Ohio
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy Recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Fox Chase Cancer Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Australia, New South Wales
Concord Repatriation General Hospital Not yet recruiting
Concord, New South Wales, Australia, 2139
Macquarie University Recruiting
North Ryde, New South Wales, Australia, 2109
Northern Cancer Institute Recruiting
Sydney, New South Wales, Australia, 2065
Australia, Queensland
Mater Misericordiae Ltd Recruiting
Brisbane, Queensland, Australia, 4101
Australia, Western Australia
Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Cliniques Universitaires Saint-Luc Recruiting
Bruxelles, Belgium, 1200
Grand Hôpital de Charleroi - Site Notre-Dame Recruiting
Charleroi, Belgium, 6000
CHU UCL Namur/Site Sainte Elisabeth Not yet recruiting
Namur, Belgium, 5000
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Denmark
Phase 1 Unit, Department of Oncology, Section 5073. Recruiting
Copenhagen, Denmark, 2100
The Experimental Cancer Therapy Unit Recruiting
Herlev, Denmark, 2730
Hungary
Orszagos Onkologiai Intezet Recruiting
Budapest, Hungary, H-1122
CRU Hungary Kft. Recruiting
Miskolc, Hungary, 3529
Pecsi Tudomanyegyetem Recruiting
Pecs, Hungary, H-7624
Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 21565
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Not yet recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Russian Federation
Medical Radiological Research Center n.a. A.F. Tsyba - Recruiting
Obninsk, Kaluga Region, Russian Federation, 249036
Medical Radiological Research Center n.a. A.F. Tsyba Recruiting
Obninsk, Kaluga Region, Russian Federation, 249036
GBUZ Recruiting
Chelyabinsk, Russian Federation, 454087
FSBI "National Medical Research Centre of Oncology n.a. Recruiting
Moscow, Russian Federation, 115478
Budget Healthcare Institution of Omsk Region "Clinical Oncology Dispensary" Recruiting
Omsk, Russian Federation, 644013
State budgetary institution of healthcare of Yaroslavl region "Clinical oncology hospital" Recruiting
Yaroslavl, Russian Federation, 150054
United Kingdom
Nuffield Health Wessex Hospital Not yet recruiting
Eastleigh, Hampshire, United Kingdom, SO53 2DW
University Hospital Southampton NHS Foundation Trust Not yet recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
University Hospitals of Leicester NHS Trust Recruiting
Leicester, United Kingdom, LE1 5WW
UCL Cancer Institute, NIHR UCLH Clinical Research Facility Recruiting
London, United Kingdom, WC1 E6DD
Freeman Hospital, The Sir Bobby Robson Cancer Trials Recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Nottingham City Hospital Not yet recruiting
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03330405     History of Changes
Other Study ID Numbers: B9991025
2017-001509-33 ( EudraCT Number )
JAVELIN PARP MEDLEY ( Other Identifier: Alias Study Number )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
NSCLC, TNBC, hormone receptor positive (HR+) breast cancer, recurrent epithelial ovarian cancer, UC, and castration resistant prostate cancer (CRPC).

Additional relevant MeSH terms:
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Antibodies, Monoclonal
Talazoparib
Immunologic Factors
Physiological Effects of Drugs
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents