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AzTrials

Metastatic Breast CancerPhase 2NCT01506609

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 Phase 2 study testing Veliparib, Carboplatin and Temozolomide in people with Metastatic Breast Cancer, run by AbbVie at 120 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Veliparib, Carboplatin and Temozolomide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
294 participants
Where
120 sitesin 20 countries
Study dates
23 Jan 2012to 2 Sep 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

120 sites in 20 countries.

120 sites in 20 countries

United States34 sites

  • Univ of Colorado Cancer Center /ID# 60751

    Aurora, Colorado, 80045

  • Johns Hopkins University /ID# 60759

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham - Main /ID# 62994

    Birmingham, Alabama, 35233

  • Lynn Cancer Institute, Boca /ID# 60749

    Boca Raton, Florida, 33486

  • Massachusetts General Hospital /ID# 64582

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute /ID# 93833

    Boston, Massachusetts, 02215

  • Medical University of South Carolina /ID# 60752

    Charleston, South Carolina, 29425

  • University of Illinois - Chicago /ID# 106175

    Chicago, Illinois, 60607

  • Northwestern University Feinberg School of Medicine /ID# 60755

    Chicago, Illinois, 60611-2927

  • Rush University Medical Center /ID# 65489

    Chicago, Illinois, 60612

  • UT Southwestern Medical Center /ID# 60745

    Dallas, Texas, 75390-7208

  • Duke University Medical Center /ID# 60747

    Durham, North Carolina, 27710-3000

  • Holy Cross Hospital /ID# 62995

    Fort Lauderdale, Florida, 33308

  • Banner MD Anderson Cancer Ctr /ID# 118695

    Gilbert, Arizona, 85234

  • Penn State University and Milton S. Hershey Medical Center /ID# 62723

    Hershey, Pennsylvania, 17033

  • Houston Methodist Hospital - Scurlock Tower /ID# 60742

    Houston, Texas, 77030

  • Moore UC San Diego Cancer Center /ID# 60754

    La Jolla, California, 92093

  • University of Arkansas for Medical Sciences /ID# 60750

    Little Rock, Arkansas, 72205

  • The Angeles Clinic and Researc /ID# 60743

    Los Angeles, California, 90025

  • The West Clinic /ID# 65487

    Memphis, Tennessee, 38120

  • The West Clinic /ID# 94599

    Memphis, Tennessee, 38120

  • The West Clinic /ID# 94600

    Memphis, Tennessee, 38120

  • Beth Israel Medical Center /ID# 87993

    New York, New York, 10003

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 63222

    New York, New York, 10065-6007

  • University of Pennsylvania /ID# 60753

    Philadelphia, Pennsylvania, 19104-5502

  • University of Pittsburgh MC /ID# 60758

    Pittsburgh, Pennsylvania, 15260

  • University of Pittsburgh MC /ID# 65486

    Pittsburgh, Pennsylvania, 15260

  • William Beaumont Hospital /ID# 95417

    Royal Oak, Michigan, 48073-6710

  • Washington University-School of Medicine /ID# 62724

    St Louis, Missouri, 63110

  • Stanford University School of Med /ID# 65488

    Stanford, California, 94305-2200

  • Moffitt Cancer Center /ID# 60746

    Tampa, Florida, 33612-9416

  • Cedars-Sinai Medical Center - West Hollywood /ID# 60760

    West Hollywood, California, 90048

  • Florida Cancer Specialists - East /ID# 60762

    West Palm Beach, Florida, 33401

  • Midwestern Regional CTC /ID# 60744

    Zion, Illinois, 60099

Other trials in United States

Russia9 sites

  • Chelyabinsk Reg Clin Oncology /ID# 63938

    Chelyabinsk, 454087

  • Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 65263

    Moscow, Moscow, 115478

  • State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 102415

    Murmansk, 183047

  • City Clinical Hospital 1 /ID# 102416

    Novosibirsk, 630075

  • Pyatigorsk Oncology Dispensary /ID# 65264

    Pyatigorsk, 357502

  • Birch A Healthcare /ID# 65265

    Saint Petersburg, 197183

  • N.N. Petrov Research Inst Onc /ID# 65269

    Saint Petersburg, 197758

  • N.N. Petrov Research Inst Onc /ID# 78973

    Saint Petersburg, 197758

  • Volgograd Reg Onc Disp #3 /ID# 98035

    Volzhsky, 404130

Other trials in Russia

Australia8 sites

  • Royal Adelaide Hospital /ID# 63280

    Adelaide, South Australia, 5000

  • Royal Hobart Hospital /ID# 63279

    Hobart, Tasmania, 7000

  • Peter MacCallum Cancer Ctr /ID# 63272

    Melbourne, Victoria, 3000

  • Royal Melbourne Hospital /ID# 63278

    Parkville, Victoria, 3050

  • Mount Hospital /ID# 65262

    Perth, Western Australia, 6000

  • The Prince of Wales Hospital /ID# 63271

    Randwick, New South Wales, 2031

  • Mater Misericordiae Limited /ID# 63276

    South Brisbane, Queensland, 4101

  • Southern Medical Day Care Ctr /ID# 63274

    Wollongong, New South Wales, 2500

Other trials in Australia

France8 sites

  • Pays-Basque Ctr Oncology/Radio /ID# 65176

    Bayonne, 64100

  • Centre Leon Berard /ID# 106675

    Lyon, Rhone, 69373

  • Institut Paoli-Calmettes /ID# 65175

    Marseille, 13273

  • Institut Curie /ID# 63926

    Paris, Île-de-France Region, 75248

  • Hopital Rene Huguenin /ID# 65177

    Saint-Cloud, 92210

  • Institut de Cancer de l'Ouest /ID# 63927

    Saint-Herblain, Loire-Atlantique, 44805

  • Centre Paul Strauss /ID# 100275

    Strasbourg, 67065

  • Hopital Universitaire Purpan /ID# 98815

    Toulouse, Haute-Garonne, 31059

Other trials in France

Israel8 sites

  • Assaf Harofeh Medical Center /ID# 65181

    Be’er Ya‘aqov, 70300

  • Soroka University Medical Center /ID# 65180

    Beersheba, 84101

  • Rambam Health Care Campus /ID# 63930

    Haifa, 3109601

  • Shaare Zedek Medical Center /ID# 116575

    Jerusalem, 91031

  • Gastroenterology Institute, Division of Medicine /ID# 63931

    Jerusalem, 91120

  • Rabin Medical Center /ID# 63929

    Petakh Tikva, Tel Aviv, 4941492

  • Sheba Medical Center /ID# 63932

    Ramat Gan, 5239424

  • Kaplan Medical Center /ID# 63933

    Rehovot, 76100

Other trials in Israel

Ukraine7 sites

  • Cherkassy Regional Onc Ctr /ID# 97698

    Cherkasy, 18000

  • Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 63940

    Dnipro, 49102

  • Communal non-profit enterprise Regional Center of Oncology /ID# 97696

    Kharkiv, 61070

  • Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 63941

    Lviv, 79031

  • Odessa National Medical Univ /ID# 65278

    Odesa, 65026

  • Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 97697

    Poltava, 36011

  • Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 65280

    Sumy, 40022

Other trials in Ukraine

Belgium6 sites

  • AZ St-Jan Brugge-Oostende AV /ID# 107315

    Bruges, West-Vlaanderen, 8000

  • Grand Hôpital de Charleroi /ID# 96136

    Charleroi, Hainaut, 6000

  • UZ Antwerp /ID# 96945

    Edegem, 2650

  • UZ Leuven /ID# 96138

    Leuven, 3000

  • CHU UCL Namur /ID# 110595

    Namur, 5000

  • Cliniques Universitaires Saint Luc /ID# 96135

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Spain6 sites

  • Hospital Universitario Vall d'Hebron /ID# 97415

    Barcelona, 08035

  • Hospital Santa Creu i Sant Pau /ID# 97418

    Barcelona, 08041

  • Hospital General Universitario Gregorio Maranon /ID# 97417

    Madrid, 28007

  • Hospital Universitario HM Sanchinarro /ID# 97416

    Madrid, 28050

  • Hospital Universitario Virgen de la Victoria /ID# 97976

    Málaga, 29010

  • Hospital Clinico Universitario de Valencia /ID# 97975

    Valencia, 46010

Other trials in Spain

Poland5 sites

  • Centrum Onkologii Lukaszczyka /ID# 73393

    Bydgoszcz, 85-796

  • Olsztynski Osrodek Onkologi /ID# 71060

    Olsztyn, 10-513

  • NZOZ Centrum Medyczne HCP /ID# 68102

    Poznan, 61-485

  • Wielkopolskie Centrum Onkologi /ID# 71061

    Poznan, 61-866

  • Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 94975

    Rzeszów, Podkarpackie Voivodeship, 35-021

Other trials in Poland

Romania5 sites

  • S.C. lanuli Med Consult SRL /ID# 106955

    Bucharest, 020962

  • lnstitutul Oncologic Trestiore /ID# 96742

    Bucharest, 022328

  • Spitalul Clinic Judetean de Urgenta /ID# 96741

    Cluj-Napoca, 400006

  • Inst Oncology Prof. Chiricuta /ID# 96740

    Cluj-Napoca, 400010

  • Sc Oncolab Srl /Id# 96745

    Craiova, 200385

Other trials in Romania

Canada4 sites

  • CHUM - Notre-Dame Hospital /ID# 67862

    Montreal, Quebec, H2X 0A9

  • Jewish General Hospital /ID# 69893

    Montreal, Quebec, H3T 1E2

  • CHUQ-Hospital St. Sacrement /ID# 68902

    Québec, Quebec, G1S 4L8

  • Sunnybrook Health Sciences Ctr /ID# 77373

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Brazil3 sites

  • Hospital Bruno Born / Sociedade Beneficencia e Caridade de Lajeado /ID# 65247

    Lajeado, Rio Grande do Sul, 95900-000

  • Irmandade da Santa Casa de /ID# 65244

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital de Clinicas de Porto Alegre /ID# 65242

    Porto Alegre, Rio Grande do Sul, 90035-903

Other trials in Brazil

Czechia3 sites

  • Masarykuv onkologicky ustav /ID# 65170

    Brno, 656 53

  • Palacky University /ID# 63923

    Olomouc, 779 00

  • Vseobecna Fakultni Nemocnice /ID# 65172

    Prague, 128 08

Other trials in Czechia

Hungary3 sites

  • Bajcsy-Zsilinszky Korhaz /ID# 65179

    Budapest, 1106

  • Debreceni Egyetem Klinikai Kozpont /ID# 65178

    Debrecen, 4032

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 63928

    Szolnok, 5004

Other trials in Hungary

Sweden3 sites

  • Sahlgrenska University Hosp /ID# 97715

    Gothenburg, 413 45

  • Skanes Universitetssjukhus /ID# 96475

    Malmö, Skåne County, 214 28

  • Karolinska Univ Sjukhuset /ID# 98037

    Solna, 17176

Other trials in Sweden

Argentina2 sites

  • Coiba /Id# 65219

    Berazategui, Buenos Aires, 1884

  • ISIS Centro Especializado /ID# 65226

    Santa Fe, 3000

Other trials in Argentina

Denmark2 sites

  • Rigshospitalet, Finsen Centre /ID# 67822

    Copenhagen, 2100

  • Vejle Sygehus /ID# 65173

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

Finland2 sites

  • Docrates Cancer Center /ID# 63924

    Helsinki, 00180

  • Tampere University Hospital /ID# 102417

    Tampere, 33521

Other trials in Finland

Netherlands1 site

  • Erasmus Medisch Centrum /ID# 96275

    Rotterdam, 3015 CE

Other trials in Netherlands

Norway1 site

  • Haukeland University Hospital /ID# 67982

    Bergen, Hordaland, 5021

Other trials in Norway

About this study

Official title: 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.

Being tested
Placebo, Veliparib, Carboplatin, Temozolomide, Paclitaxel
Keywords
PARP, TMZ, Temodal, Carboplatin, veliparib, BRCA2 mutation carrier, Breast cancer, Metastatic breast cancer, temozolomide, BRCA1 mutation carrier, ABT-888, Paclitaxel, Recurrent breast cancer, Temodar, Locally recurrent
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01506609
Study groupRoleWhat they receive
Veliparib with TemozolomideExperimentalVeliparib 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.
Receives: Drug: Veliparib; Drug: Temozolomide
Placebo with Carboplatin and PaclitaxelPlacebo comparatorPlacebo 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.
Receives: Drug: Placebo; Drug: Carboplatin; Drug: Paclitaxel
Veliparib with Carboplatin and PaclitaxelExperimentalVeliparib 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.
Receives: Drug: Veliparib; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (4)

  1. 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.

    Measured: 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.

  2. 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).

    Measured: Week 18

  3. 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.

    Measured: 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.

  4. 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.

    Measured: Baseline, Week 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2012 (estimated)
  2. Study start23 Jan 2012
  3. Primary completion13 Dec 2018
  4. Study completion2 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
294 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01506609
Sponsor's protocol ID
M12-895
Other IDs
2011-002913-12
Status last verified
Sep 2021
First submitted
6 Jan 2012
Last updated
25 Oct 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

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.

    PubMed 29045554

  • 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.

    PubMed 27739325

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Veliparib, Carboplatin and Temozolomide in people with Metastatic Breast Cancer, run by AbbVie at 120 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Russia, Australia, France, Israel and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01506609, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.

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