Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer

A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Placebo; Drug: Temozolomide; Drug: Carboplatin; Drug: Paclitaxel; Drug: Veliparib

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Berazategui, Buenos Aires, Argentina, 1884
    • Coiba /Id# 65219
  • Santa Fe, Argentina, 3000
    • ISIS Centro Especializado /ID# 65226
• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • The Prince of Wales Hospital /ID# 63271
    • Wollongong, New South Wales, Australia, 2500
      • Southern Medical Day Care Ctr /ID# 63274
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Misericordiae Limited /ID# 63276
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital /ID# 63280
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital /ID# 63279
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Ctr /ID# 63272
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital /ID# 63278
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Mount Hospital /ID# 65262
• Belgium
  • Edegem, Belgium, 2650
    • UZ Antwerp /ID# 96945
  • Leuven, Belgium, 3000
    • UZ Leuven /ID# 96138
  • Namur, Belgium, 5000
    • CHU UCL Namur /ID# 110595
  • Bruxelles-Capitale
    • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
      • Cliniques Universitaires Saint Luc /ID# 96135
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6000
      • Grand Hôpital de Charleroi /ID# 96136
  • West-Vlaanderen
    • Brugge, West-Vlaanderen, Belgium, 8000
      • AZ St-Jan Brugge-Oostende AV /ID# 107315
• Brazil
  • Rio Grande Do Sul
    • Lajeado, Rio Grande Do Sul, Brazil, 95900-000
      • Hospital Bruno Born / Sociedade Beneficencia e Caridade de Lajeado /ID# 65247
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
      • Irmandade da Santa Casa de /ID# 65244
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre /ID# 65242
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Ctr /ID# 77373
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital /ID# 69893
    • Montréal, Quebec, Canada, H2X 0A9
      • CHUM - Notre-Dame Hospital /ID# 67862
    • Quebec City, Quebec, Canada, G1S 4L8
      • CHUQ-Hospital St. Sacrement /ID# 68902
• Czechia
  • Brno, Czechia, 656 53
    • Masarykuv onkologicky ustav /ID# 65170
  • Olomouc, Czechia, 779 00
    • Palacky University /ID# 63923
  • Prague, Czechia, 128 08
    • Vseobecna Fakultni Nemocnice /ID# 65172
• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet, Finsen Centre /ID# 67822
  • Syddanmark
    • Vejle, Syddanmark, Denmark, 7100
      • Vejle Sygehus /ID# 65173
• Finland
  • Helsinki, Finland, 00180
    • Docrates Cancer Center /ID# 63924
  • Tampere, Finland, 33521
    • Tampere University Hospital /ID# 102417
• France
  • Bayonne, France, 64100
    • Pays-Basque Ctr Oncology/Radio /ID# 65176
  • Marseille, France, 13273
    • Institut Paoli-Calmettes /ID# 65175
  • Saint-cloud, France, 92210
    • Hopital Rene Huguenin /ID# 65177
  • Strasbourg, France, 67065
    • Centre Paul Strauss /ID# 100275
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • Hopital Universitaire Purpan /ID# 98815
  • Ile-de-France
    • Paris CEDEX 05, Ile-de-France, France, 75248
      • Institut Curie /ID# 63926
  • Loire-Atlantique
    • St Herblain CEDEX, Loire-Atlantique, France, 44805
      • Institut de Cancer de l'Ouest /ID# 63927
  • Rhone
    • Lyon CEDEX 08, Rhone, France, 69373
      • Centre Leon Berard /ID# 106675
• Hungary
  • Budapest, Hungary, 1106
    • Bajcsy-Zsilinszky Korhaz /ID# 65179
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont /ID# 65178
  • Szolnok, Hungary, 5004
    • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 63928
• Israel
  • Be'er Sheva, Israel, 84101
    • Soroka University Medical Center /ID# 65180
  • Be'er Ya'akov, Israel, 70300
    • Assaf Harofeh Medical Center /ID# 65181
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 63930
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center /ID# 116575
  • Jerusalem, Israel, 91120
    • Gastroenterology Institute, Division of Medicine /ID# 63931
  • Ramat Gan, Israel, 5239424
    • Sheba Medical Center /ID# 63932
  • Rehovot, Israel, 76100
    • Kaplan Medical Center /ID# 63933
  • Tel-Aviv
    • Petakh Tikva, Tel-Aviv, Israel, 4941492
      • Rabin Medical Center /ID# 63929
• Netherlands
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medisch Centrum /ID# 96275
• Norway
  • Hordaland
    • Bergen, Hordaland, Norway, 5021
      • Haukeland University Hospital /ID# 67982
• Poland
  • Bydgoszcz, Poland, 85-796
    • Centrum Onkologii Lukaszczyka /ID# 73393
  • Olsztyn, Poland, 10-513
    • Olsztynski Osrodek Onkologi /ID# 71060
  • Poznan, Poland, 61-485
    • NZOZ Centrum Medyczne HCP /ID# 68102
  • Poznan, Poland, 61-866
    • Wielkopolskie Centrum Onkologi /ID# 71061
  • Podkarpackie
    • Rzeszów, Podkarpackie, Poland, 35-021
      • Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 94975
• Romania
  • Bucharest, Romania, 020962
    • S.C. lanuli Med Consult SRL /ID# 106955
  • Bucharest, Romania, 022328
    • lnstitutul Oncologic Trestiore /ID# 96742
  • Cluj, Romania, 400006
    • Spitalul Clinic Judetean de Urgenta /ID# 96741
  • Cluj, Romania, 400010
    • Inst Oncology Prof. Chiricuta /ID# 96740
  • Craiova, Romania, 200385
    • Sc Oncolab Srl /Id# 96745
• Russian Federation
  • Chelyabinsk, Russian Federation, 454087
    • Chelyabinsk Reg Clin Oncology /ID# 63938
  • Murmansk, Russian Federation, 183047
    • State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 102415
  • Novosibirsk, Russian Federation, 630075
    • City Clinical Hospital 1 /ID# 102416
  • Pyatigorsk, Russian Federation, 357502
    • Pyatigorsk Oncology Dispensary /ID# 65264
  • St. Petersburg, Russian Federation, 197183
    • Birch A Healthcare /ID# 65265
  • St. Petersburg, Russian Federation, 197758
    • N.N. Petrov Research Inst Onc /ID# 65269
  • St. Petersburg, Russian Federation, 197758
    • N.N. Petrov Research Inst Onc /ID# 78973
  • Volzhsky, Russian Federation, 404130
    • Volgograd Reg Onc Disp #3 /ID# 98035
  • Moskva
    • Moscow, Moskva, Russian Federation, 115478
      • Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 65263
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 97415
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau /ID# 97418
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon /ID# 97417
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro /ID# 97416
  • Malaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria /ID# 97976
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia /ID# 97975
• Sweden
  • Goteborg, Sweden, 413 45
    • Sahlgrenska University Hosp /ID# 97715
  • Solna, Sweden, 17176
    • Karolinska Univ Sjukhuset /ID# 98037
  • Skane Lan
    • Malmö, Skane Lan, Sweden, 214 28
      • Skanes Universitetssjukhus /ID# 96475
• Ukraine
  • Cherkasy, Ukraine, 18000
    • Cherkassy Regional Onc Ctr /ID# 97698
  • Dnipro, Ukraine, 49102
    • Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 63940
  • Kharkiv, Ukraine, 61070
    • Communal non-profit enterprise Regional Center of Oncology /ID# 97696
  • Lviv, Ukraine, 79031
    • Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 63941
  • Odesa, Ukraine, 65026
    • Odessa National Medical Univ /ID# 65278
  • Poltava, Ukraine, 36011
    • Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 97697
  • Sumy, Ukraine, 40022
    • Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 65280
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham - Main /ID# 62994
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson Cancer Ctr /ID# 118695
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences /ID# 60750
  • California
    • La Jolla, California, United States, 92093
      • Moore UC San Diego Cancer Center /ID# 60754
    • Los Angeles, California, United States, 90025
      • The Angeles Clinic and Researc /ID# 60743
    • Stanford, California, United States, 94305-2200
      • Stanford University School of Med /ID# 65488
    • West Hollywood, California, United States, 90048
      • Cedars-Sinai Medical Center - West Hollywood /ID# 60760
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Univ of Colorado Cancer Center /ID# 60751
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Lynn Cancer Institute, Boca /ID# 60749
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital /ID# 62995
    • Tampa, Florida, United States, 33612-9416
      • Moffitt Cancer Center /ID# 60746
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists - East /ID# 60762
  • Illinois
    • Chicago, Illinois, United States, 60607
      • University of Illinois - Chicago /ID# 106175
    • Chicago, Illinois, United States, 60611-2927
      • Northwestern University Feinberg School of Medicine /ID# 60755
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center /ID# 65489
    • Zion, Illinois, United States, 60099
      • Midwestern Regional CTC /ID# 60744
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University /ID# 60759
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital /ID# 64582
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute /ID# 93833
  • Michigan
    • Royal Oak, Michigan, United States, 48073-6710
      • William Beaumont Hospital /ID# 95417
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 62724
  • New York
    • New York, New York, United States, 10003
      • Beth Israel Medical Center /ID# 87993
    • New York, New York, United States, 10065-6007
      • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 63222
  • North Carolina
    • Durham, North Carolina, United States, 27710-3000
      • Duke University Medical Center /ID# 60747
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State University and Milton S. Hershey Medical Center /ID# 62723
    • Philadelphia, Pennsylvania, United States, 19104-5502
      • University of Pennsylvania /ID# 60753
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh MC /ID# 60758
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh MC /ID# 65486
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina /ID# 60752
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • The West Clinic /ID# 65487
    • Memphis, Tennessee, United States, 38120
      • The West Clinic /ID# 94599
    • Memphis, Tennessee, United States, 38120
      • The West Clinic /ID# 94600
  • Texas
    • Dallas, Texas, United States, 75390-7208
      • UT Southwestern Medical Center /ID# 60745
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital - Scurlock Tower /ID# 60742

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.
• Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.
• Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.
• If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.
• Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
• Subject must have adequate bone marrow, renal and hepatic function.
• Subject must not be pregnant or plan to conceive a child.

Exclusion Criteria:

• Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1.
• More than 2 prior lines of cytotoxic chemotherapy.
• Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.
• Prior taxane therapy for metastatic breast cancer.
• A history of or evidence of brain metastases or leptomeningeal disease.
• A history of uncontrolled seizure disorder.
• Pre-existing neuropathy from any cause in excess of Grade 1.
• Known history of allergic reaction to cremophor/paclitaxel.
• Clinical significant uncontrolled conditions, active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.
• Pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Veliparib with Temozolomide; Veliparib 40 mg twice daily (BID) Days 1 through 7 plus TMZ 150 to 200 mg/m^2 QD Days 1 through 5 in each 28-day cycle.	Drug: Temozolomide; Other Names: Temodal; Drug: Veliparib; Other Names: ABT-888
Placebo Comparator: Placebo with Carboplatin and Paclitaxel; Placebo BID Days 1 through 7 plus carboplatin target area under the curve (mg•min/mL) (AUC) 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Drug: Placebo; Drug: Carboplatin; Drug: Paclitaxel; Other Names: Taxol
Experimental: Veliparib with Carboplatin and Paclitaxel; Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m^2 administered on Day 3 of each 21-day cycle.	Drug: Carboplatin; Drug: Paclitaxel; Other Names: Taxol; Drug: Veliparib; Other Names: ABT-888

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS is defined as the number of months from the date the participant was randomized to the date of radiographic progression as determined by the central imaging center, or to the date of all cause deaths within 63 days of last tumor assessment if disease progression was not reached.	Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for PFS was 34 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time to death for a given participant was defined as the number of months from the day the participant is randomized to the date of the participant's death. All events of death were included, regardless of whether the event occurs while the participant was still taking study drug, or after the participant discontinued study drug. If a participant had not died, then the data will be censored at the date when the participant was last known to be alive.	From Cycle 1 Day 1 until participant's death or 3 years post discontinuation (data cutoff date: 04 March 2016); maximum duration of follow up for OS was 72 months.
Clinical Benefit Rate (CBR) at Week 18	CBR: percentage of participants who were progression-free at 18 weeks, defined as complete response (CR), partial response (PR), stable disease (SD) or non-CR/non-disease progression (PD) per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1. CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 0 mm. PR: >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters (SOD). PD: >= 20% increase in the SOD of target lesions, taking as reference the smallest SOD recorded since the treatment started (baseline or after) or the appearance of >=1 new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD since the treatment started (baseline or after).	Week 18
Objective Response Rate (ORR)	The objective response rate, defined as percentage of participants with a confirmed CR or PR based on RECIST 1.1 criteria. CR: The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 0 mm. PR: >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline SODs.	Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for ORR was 34 months.
Change From Baseline at Week 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Subscale Score	EORTC QLQ-CIPN20 sensory subscale score was calculated following the standard scoring algorithm, transformed to a 0 (low quality of life) to 100 (best quality of life) scale. A positive change from baseline indicates improvement.	Baseline, Week 18

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• Han HS, Dieras V, Robson M, Palacova M, Marcom PK, Jager A, Bondarenko I, Citrin D, Campone M, Telli ML, Domchek SM, Friedlander M, Kaufman B, Garber JE, Shparyk Y, Chmielowska E, Jakobsen EH, Kaklamani V, Gradishar W, Ratajczak CK, Nickner C, Qin Q, Qian J, Shepherd SP, Isakoff SJ, Puhalla S. Veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in patients with BRCA1/2 locally recurrent/metastatic breast cancer: randomized phase II study. Ann Oncol. 2018 Jan 1;29(1):154-161. doi: 10.1093/annonc/mdx505.
• Isakoff SJ, Puhalla S, Domchek SM, Friedlander M, Kaufman B, Robson M, Telli ML, Dieras V, Han HS, Garber JE, Johnson EF, Maag D, Qin Q, Giranda VL, Shepherd SP. A randomized Phase II study of veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in BRCA1/2 metastatic breast cancer: design and rationale. Future Oncol. 2017 Feb;13(4):307-320. doi: 10.2217/fon-2016-0412. Epub 2016 Oct 14.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2012
• Primary Completion (Actual): December 13, 2018
• Study Completion (Actual): September 2, 2020

Study Registration Dates

• First Submitted: January 6, 2012
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 10, 2012

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: veliparib; ABT-888; Breast cancer; Temodar; Carboplatin; Metastatic breast cancer; Paclitaxel; PARP; temozolomide; TMZ; Temodal; BRCA2 mutation carrier; BRCA1 mutation carrier; Recurrent breast cancer; Locally recurrent
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Phytogenic; Poly(ADP-ribose) Polymerase Inhibitors; Carboplatin; Paclitaxel; Temozolomide; Veliparib
• Other Study ID Numbers: M12-895; 2011-002913-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No