AzTrials
AzTrials

Endometrial NeoplasmsPhase 2NCT02725268

A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer

A Phase 2 study testing Paclitaxel, Sapanisertib and MLN1117 in people with Endometrial Neoplasms, run by Millennium Pharmaceuticals, Inc. at 78 sites in 10 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 purpose of this study is to determine if sapanisertib in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Neoplasms
What is being tested?
Paclitaxel, Sapanisertib and MLN1117
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
78 sitesin 10 countries
Study dates
1 Apr 2016to 30 Oct 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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic or cytologic diagnosis of endometrial carcinoma (including endometrioid, serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma).
  • Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed or is refractory to curative therapy or established treatments.
  • At least 1 prior platinum-based chemotherapeutic regimen, but not more than 2 prior chemotherapeutic regimens, for management of endometrial carcinoma. Prior treatment may include chemotherapy, chemotherapy/radiation therapy, and/or consolidation/maintenance therapy. Chemotherapy administered in conjunction with primary radiation as a radio-sensitized therapy will be considered a systemic chemotherapy regimen.
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded). Each lesion must be greater than or equal to (>=) 10 millimeter (mm) in long axis when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam. Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI.
  • Tumor accessible and participant consents to undergo fresh tumor biopsies.
  • Female participants 18 years or older.
Show all 20Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Female participants who:
  • Are postmenopausal for at least 1 year before the screening visit, OR
  • Are surgically sterile, OR
  • If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [example, United States Prescribing Information (USPI), Summary of Product Characteristics (SmPC), etc.]) after the last dose of study drug, OR
  • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
  • Clinical laboratory values as specified below within 4 weeks before the first dose of study drug:
  • Bone marrow reserve consistent with absolute neutrophil count (ANC) >= 1500 per micro liter (/mcL); platelet count >= 100,000/mcL; hemoglobin A1c (HbA1c) less than (<) 6.5 percent (%).
  • Total bilirubin must be less than or equal to (<=) 1.5 * the upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be <= 2.5 * the upper limit of the normal range. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of metastatic disease in liver.
  • Creatinine clearance >= 50 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) based either on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection.
  • Fasting serum glucose < 130 milligram per deciliter (mg/dL) and fasting triglycerides <= 300 mg/dL.
  • Ability to swallow oral medications, willingness to perform mucositis prophylaxis, and suitable venous access for the study-required blood sampling.
  • Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.

Who cannot join

  • Positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug. Women who are lactating and breastfeeding are not eligible.
  • Previous treatment with any weekly taxane regimen.
  • History of severe hypersensitivity reactions to paclitaxel or any of its excipients.
  • Previous treatment with phosphoinositide 3-kinase (PI3K), serine/threonine-specific protein kinase (AKT), dual PI3K/ mammalian (or mechanistic) target of rapamycin (mTOR) inhibitors, target of rapamycin complex 1/2 (TORC1/2) inhibitors or TORC1 inhibitors.
  • Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids (either intravenous [IV] or oral steroids, excluding inhalers) within 1 week before administration of the first dose of study drug (participants already receiving erythropoietin on a chronic basis for >=4 weeks are eligible).
  • Participants who are taking proton pump inhibitors (PPIs) within 7 days of the first dose of study drug or who require treatment with PPIs throughout the trial or those who are taking H2 receptor antagonists within 24 hours of the first dose of study drug.
Show all 30Show fewer
  • A prothrombin time (PT) or activated partial thromboplastin time (aPTT) above the ULN or a history of a coagulopathy or bleeding disorder.
  • Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
  • Sensory or motor neuropathy >= Grade 2.
  • Central nervous system (CNS) metastasis, endometrial leiomyosarcoma, or endometrial stromal sarcoma.
  • Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal disease, or for some other reason that may alter the absorption of sapanisertib or MLN1117. In addition, participants with enteric stomata are also excluded.
  • Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active CNS disease, active infection, or any other condition that could compromise participation of the participant in the study.
  • Known human immunodeficiency virus infection.
  • History of any of the following within the last 6 months before administration of the first dose of study drug:
  • Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures.
  • Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures.
  • Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia).
  • Placement of a pacemaker for control of rhythm.
  • New York Heart Association Class III or IV heart failure.
  • Pulmonary embolism.
  • Significant active cardiovascular or pulmonary disease before administration of the first dose of study drug, including:
  • Uncontrolled hypertension (that is, either systolic blood pressure > 180 millimeter of mercury [mm Hg] or diastolic blood pressure > 95 mm Hg).
  • Pulmonary hypertension.
  • Uncontrolled asthma or oxygen saturation < 90% by arterial blood gas analysis or pulse oximetry on room air.
  • Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention; or history of valve replacement.
  • Medically significant (symptomatic) bradycardia.
  • History of arrhythmia requiring an implantable cardiac defibrillator.
  • Baseline prolongation of the rate-corrected QT interval (QTc; example, repeated demonstration of QTc interval > 480 millisecond [ms], or history of congenital long QT syndrome, or torsades de pointes).
  • Diagnosed or treated for another malignancy within 2 years before administration of the first dose of study drug or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • Participants with endometrioid histology and histologically confirmed expression of estrogen receptors (ER) and/or progesterone receptors (PgR) who have not received prior endocrine therapy and for whom endocrine therapy is currently indicated.

Trial locations and contacts

78 sites in 10 countries.

78 sites in 10 countries

United States21 sites

  • Augusta University

    Augusta, Georgia, 30912

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Marin Cancer Care

    Greenbrae, California, 94904

  • Franciscan St. Francis Health

    Indianapolis, Indiana, 46237

  • University of California San Diego Medical Center

    La Jolla, California, 92093-1503

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • NYU Langone Medical Center Clinic

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065-6094

  • Oklahoma University Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Arizona Cancer Center

    Phoenix, Arizona, 85013

  • University of Pittsburgh Medical Center Cancer Center at Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15232

  • University of California at San Francisco (PARENT)

    San Francisco, California, 94115

  • Washington University

    St Louis, Missouri, 63108

  • Stanford School of Medicine

    Stanford, California, 94305

  • H. Lee Moffitt Cancer Center and Research Institute, Inc

    Tampa, Florida, 33612-9416

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • University of Kansas Medical Center Research Institute, Inc.

    Westwood, Kansas, 66205

Other trials in United States

Italy10 sites

  • Spedali Civili di Brescia

    Brescia, 25123

  • Ente Ospedaliero Ospedali Galliera

    Genova, 16128

  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

    Meldola, Forli - Cesena, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

  • Istituto Tumori Napoli Fondazione G. Pascale

    Naples, 80131

  • Azienda Unita Sanitaria Locale di Ravenna

    Ravenna, 48121

  • Istituto Nationale Tumori Regina Elena

    Roma, 00144

  • Universita degli Studi di Roma "La Sapienza" - Umberto I Policlinico di Roma

    Roma, 00161

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

Other trials in Italy

United Kingdom9 sites

  • Bristol Haematology and Oncology Centre

    Bristol, Avon, BS2 8ED

  • University Hospital Coventry

    Coventry, CV2 2DX

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, Devon, EX2 5DW

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • University College London Hospitals

    London, Greater London, NW1 2BU

  • Royal Marsden Hospital

    London, Greater London, SW3 6JJ

  • Hammersmith Hospital

    London, Greater London, W12 0HS

  • The Christie

    Manchester, Greater Manchester, M20 4BX

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Australia7 sites

  • Monash Medical Centre Clayton

    Clayton, Victoria, 3168

  • Sunshine Hospital

    Footscray, Victoria, 3011

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Cabrini Hospital Malvern

    Malvern, Victoria, 3144

  • Peter MacCallum Cancer Centre-East Melbourne

    Melbourne, Victoria, 3000

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Spain7 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • MD Anderson Cancer Centre

    Madrid, 28033

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Instituto Valenciano de Oncologia IVO

    Valencia, 46009

Other trials in Spain

Canada6 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Juravinski Cancer Clinic

    Hamilton, Ontario, L8V 5C2

  • LHSC - Victoria Hospital

    London, Ontario, N6A 4L6

  • CHUM Hopital Notre-Dame

    Montreal, Quebec, H2X 3E4

  • Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Belgium5 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

  • UZ Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liege Site Sart Tilman

    Liège, 4000

  • GasthuisZusters Antwerpen Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

Germany5 sites

  • Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum

    Berlin, 13353

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, Saxony, 01307

  • Universitaetsmedizin Greifswald

    Greifswald, Mecklenburg-Vorpommern, 17489

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538

Other trials in Germany

Netherlands5 sites

  • Academisch Medisch Centrum

    Amsterdam, North Holland, 1105 AZ

  • Universitair Medisch Centrum Groningen

    Groningen, 9700 RB

  • Maastricht Universitair Medisch Centrum

    Maastricht, Limburg, 6229 HX

  • Erasmus Medisch Centrum Daniel den Hoed

    Rotterdam, South Holland, 3015 GD

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Norway3 sites

  • Haukeland universitetssykehus, Kvinneklinikken

    Bergen, 5021

  • Radiumhospitalet

    Oslo, 0310

  • Stavanger University Hospital

    Stavanger, 4011

Other trials in Norway

About this study

Official title: A Phase 2, Randomized Study of MLN0128 (a Dual TORC1/2 Inhibitor), MLN0128+MLN1117 (a PI3Kα Inhibitor), Weekly Paclitaxel, or the Combination of Weekly Paclitaxel and MLN0128 in Women With Advanced, Recurrent, or Persistent Endometrial Cancer

The primary purpose of this study is to determine if sapanisertib in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone.

Read the detailed description

The drugs being evaluated in this study are sapanisertib and MLN1117. Sapanisertib is being evaluated as a single agent and in combination with paclitaxel or MLN1117 to treat women with advanced, recurrent, or persistent endometrial cancer. This study will evaluate the efficacy and safety of each drug or drug combination.

The study will enroll approximately 241 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of 4 treatment groups:

  • Paclitaxel 80 mg/m^2
  • Paclitaxel 80 mg/m^2 + Sapanisertib 4 mg
  • Sapanisertib 30 mg
  • Sapanisertib 4 mg + MLN1117 200 mg

Participants will receive either paclitaxel intravenous (IV) weekly, Paclitaxel IV along with sapanisertib orally, sapanisertib orally, or sapanisertib and MLN1117 orally.

This is a multicenter, multinational trial. Participants will make multiple visits to the clinic, with an end of treatment visit (EOT) which will occur 30 to 40 days after receiving their last dose of study drug or before the start of any subsequent anticancer therapy. After EOT, participants will be followed for PFS and overall survival (OS).

Being tested
Paclitaxel, Sapanisertib, MLN1117
Keywords
Drug Therapy
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • PaclitaxelDrug

    Paclitaxel intravenous solution.

  • SapanisertibDrug

    Also called MLN0128, INK128, TAK-228

    Sapanisertib capsules.

  • MLN1117Drug

    Also called TAK-117, INK1117

    MLN1117 capsules.

Study groups in NCT02725268
Study groupRoleWhat they receive
Paclitaxel 80 mg/m^2ExperimentalPaclitaxel 80 milligrams per square meter (mg/m^2), IV, weekly on Days 1, 8, and 15 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was up to approximately 13 weeks).
Receives: Drug: Paclitaxel
Paclitaxel 80 mg/m^2 + Sapanisertib 4 mgExperimentalPaclitaxel 80 mg/m^2, IV, weekly on Days 1, 8, and 15 of a 28-day cycle along with sapanisertib 4 milligrams (mg), capsule, orally on Days 2-4, 9-11, 16-18, and 23-25 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was up to approximately 20 weeks).
Receives: Drug: Paclitaxel; Drug: Sapanisertib
Sapanisertib 30 mgExperimentalSapanisertib 30 mg, capsule, orally, once weekly on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was up to approximately 6 weeks).
Receives: Drug: Sapanisertib
Sapanisertib 4 mg + MLN1117 200 mgExperimentalSapanisertib 4 mg, capsule, orally and MLN1117 200 mg, capsule, orally on Days 1-3, 8-10, 15-17, and 22-24 of a 28-day cycle until disease progression, unacceptable toxicity, or withdraw consent (the median exposure was up to approximately 8 weeks).
Receives: Drug: Sapanisertib; Drug: MLN1117

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 time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Up to approximately 30 months

Secondary outcomes (6)

  1. Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)

    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

    Measured: From the first dose of study drug through 30 days after the last dose of study drug (Up to approximately 54 months)

  2. Overall Survival (OS)

    OS is defined as the time in months from the date of randomization to the date of death.

    Measured: Up to approximately 54 months

  3. Time to Tumor Progression (TTP)

    TTP is defined as the time in months from the date of randomization to the date of first documentation of progression. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Up to 30 months

  4. Overall Response Rate (ORR)

    ORR is defined as the percentage of participants who achieved a best response of a complete response (CR) or partial response (PR). Per RECIST v1.1, CR was defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.

    Measured: Up to 30 months

  5. Clinical Benefit Rate (CBR)

    CBR is defined as the percentage of participants with CR or PR or SD (SD of any duration). Per RECIST v1.1, CR was defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Up to 30 months

  6. Clinical Benefit Rate (CBR) at Week 16 (CBR-16)

    CBR-16 is defined as the percentage of participants who achieved CR or PR of any duration or have SD with a duration of at least 16 weeks. Per RECIST v1.1, CR was defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Week 16

Timeline

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

  1. First posted31 Mar 2016 (estimated)
  2. Study start1 Apr 2016
  3. Primary completion2 Jul 2019
  4. Study completion30 Oct 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
None (open label)
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02725268
Sponsor's protocol ID
C31004
Other IDs
U1111-1168-1824, 2014-005394-37, 02725268, 2014
Status last verified
Oct 2021
First submitted
28 Mar 2016
Last updated
24 Nov 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Publications

  • Han SN, Oza A, Colombo N, Oaknin A, Raspagliesi F, Wenham RM, Braicu EI, Jewell A, Makker V, Krell J, Alia EMG, Baurain JF, Su Z, Neuwirth R, Vincent S, Sedarati F, Faller DV, Scambia G. A randomized phase 2 study of sapanisertib in combination with paclitaxel versus paclitaxel alone in women with advanced, recurrent, or persistent endometrial cancer. Gynecol Oncol. 2023 Nov;178:110-118. doi: 10.1016/j.ygyno.2023.09.013. Epub 2023 Oct 14.

    PubMed 37839313

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Sapanisertib and MLN1117 in people with Endometrial Neoplasms, run by Millennium Pharmaceuticals, Inc. at 78 sites in 10 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 20 inclusion and 30 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 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Italy, United Kingdom, Australia, Spain and 5 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. 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 9 Jun 2020). 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: Up to approximately 30 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 NCT02725268, which also lists 1 linked publication.

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 24 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in