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Metastatic Pancreatic CancerPhase 2NCT01839487

PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer

A Phase 2 study testing PEGPH20, Nab-paclitaxel and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Halozyme Therapeutics at 51 sites in United States.

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

This study is designed to compare the treatment effect of PEGPH20 combined with nab-paclitaxel (NAB) and gemcitabine (GEM) [PAG] to NAB and GEM [AG] in participants with Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
PEGPH20, Nab-paclitaxel and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
279 participants
Where
51 sitesUnited States
Study dates
14 May 2013to 26 Sep 2018
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

  • Signed Informed consent.
  • Histologically confirmed Stage IV PDA with documented disseminated neoplasm to liver and /or lung. Must have archival or fresh tissue (block /slides) available pre-dose.
  • One or more metastatic tumors measurable on computed tomography (CT) scan per RECIST v.1.1 , excluding the primary pancreatic lesion.
  • No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
  • Karnofsky Performance Status greater than or equal to (≥) 70%.
  • Life expectancy ≥3 months.
  • Age ≥18 years.
  • Screening laboratory values of hemoglobin, platelets, absolute neutrophil count (ANC), bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum creatinine, serum albumin, prothrombin time/international normalized ratio (INR), and partial thromboplastin time (PTT) within specified values/criteria per protocol prior to dosing.

Who cannot join

  • Non-metastatic PDA.
  • Evidence of deep vein thrombosis (DVT), pulmonary embolism (PE), or other known thromboembolic event present during screening period.
  • Known central nervous system involvement or brain metastasis.
  • New York (NY) Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
  • Prior history of cerebrovascular accident or transient ischemic attack.
  • Pre-existing carotid artery disease.
Show all 13Show fewer
  • Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
  • Current use of megestrol acetate (use within 10 days of Day 1).
  • Known infection with human immunodeficiency virus, Hepatitis B, or Hepatitis C.
  • History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early state prostate cancer, or curatively-treated cervical cancer in-situ.
  • Contraindication to heparin as per National Comprehensive Cancer Network (NCCN) guidelines.
  • Previous major bleed (bleeding requiring transfusion of red blood cells) on low-molecular weight heparin (LMWH).
  • Any other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of disease or condition that contraindicates the use of an investigational drug, that may affect interpretation of results, or render the participant at a high risk of treatment complications.

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

United States51 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Piedmont Hospital

    Atlanta, Georgia, 30318

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Johns Hopkins University Hospital

    Baltimore, Maryland, 21231

  • Alabama Oncology

    Birmingham, Alabama, 35213

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence St Joseph Medical Center

    Burbank, California, 91505

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Texas Oncology - Baylor

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Greenville Health System

    Greenville, South Carolina, 29605

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Columbia Basin Hematology and Oncology

    Kennewick, Washington, 99336

  • Scripps Cancer Center

    La Jolla, California, 92037

  • UCSD - Moore's Cancer Center

    La Jolla, California, 92093

  • North Shore Long Island Jewish Health System

    Lake Success, New York, 11042

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Norton Cancer Institute - Norton HealthCare Pavilion

    Louisville, Kentucky, 40202

  • University of Wisconsin Hospitals and Clinics

    Madison, Wisconsin, 53792

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Miami, Sylvester comprehensive Cancer Center

    Miami, Florida, 33136

  • Froedtert Hospital, Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Unniversity of Minnesota

    Minneapolis, Minnesota, 55455

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • Cancer Care Centers of South Texas

    New Braunfels, Texas, 78130

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73104

  • University of California Medical Center

    Orange, California, 92868

  • St. Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15213

  • University of Rochester

    Rochester, New York, 14642

  • Pacific Hematology Oncology Associates

    San Francisco, California, 94115

  • Mayo Clinic - Scottsdale

    Scottsdale, Arizona, 85259

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Saint Helena Hospital

    St. Helena, California, 94574

  • Stamford Hospital

    Stamford, Connecticut, 06902

  • NorthWest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • H. Lee Moffit Cancer Center

    Tampa, Florida, 33612

  • Arizona Oncology Associates, PC

    Tucson, Arizona, 85704

  • Texas Oncology

    Tyler, Texas, 75702

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90603

  • University of Mass Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Combined With Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Previously Untreated Pancreatic Cancer

This study is designed to compare the treatment effect of PEGPH20 combined with nab-paclitaxel (NAB) and gemcitabine (GEM) [PAG] to NAB and GEM [AG] in participants with Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).

The study will have 2 run-in phases, one for each formulation of PEGPH20 (original and new formulations), and a Phase 2 portion. The 2 run-in phases will evaluate the safety and tolerability of the PAG treatment using the original and new succinic acid PEGPH20 formulation, respectively, compared with AG treatment. Phase 2 will have 2 stages due to a partial clinical hold that occurred from April through July 2014. The participants will be randomized in 3:1 for the run-in phases. The first stage will randomize participants in a 1:1 ratio. The second stage will randomize participants in a 2:1 ratio (PAG:AG).

This is an open-label study. To minimize bias to the progression-free survival endpoint, disease progression will be based on the assessment of the Central Imaging Reader (CIR). Determination of clinical progression by the Investigator without corresponding CIR confirmation will be documented with the relevant signs and symptoms.

Being tested
PEGPH20, Nab-paclitaxel, Gemcitabine, Dexamethasone, Enoxaparin
Keywords
pancreatic ductal carcinoma(PDA), Pancreatic ductal carcinoma, PEGPH20, Gemcitabine, Nab-paclitaxel
Medical subject headings
Pancreatic Neoplasms, Carcinoma, Pancreatic Ductal

What participants receive

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

  • PEGPH20Drug

    PEGPH20 will be administered as per the dose and schedule specified in the respective arms.

  • Nab-paclitaxelDrug

    Also called Abraxane

    Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine will be administered as per the dose and schedule specified in the respective arms.

  • DexamethasoneDrug

    Dexamethasone will be administered as per the dose and schedule specified in the respective arms.

  • EnoxaparinDrug

    Enoxaparin will be administered as per the dose and schedule specified in the respective arms.

Study groups in NCT01839487
Study groupRoleWhat they receive
Run-in Phase - PAG: PEGPH20 + Nab-paclitaxel + GemcitabineExperimentalParticipants will receive 3.0 micrograms/kilogram (mcg/kg) PEGPH20 with 125 milligrams/square meter (mg/m^2) NAB and 1000 mg/m^2 GEM as intravenous (IV) infusion. In Cycle 1 Week 1, PEGPH20 will be administered alone on Days 1 and 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15 and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1 8 and 15. NAB+GEM will be given 2 to 4 hours after PEGPH20 dose. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior and 8 to 12 hours after completion of each PEGPH20 infusion.
Receives: Drug: PEGPH20; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Dexamethasone
Run-in Phase - AG: Nab-paclitaxel + GemcitabineActive comparatorParticipants will receive 125 mg/m^2 NAB and 1000 mg/m^2 GEM, as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion.
Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Dexamethasone
Phase 2: Stage 1 - PAG: PEGPH20 + Nab-paclitaxel + GemcitabineExperimentalParticipants will receive 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 will be given alone on Days 1 and Day 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15, and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1, 8, and 15. NAB+GEM will be given 2 to 4 hours after dose of PEGPH20. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning and 8 to 12 hours after the completion of each PEGPH20 infusion.
Receives: Drug: PEGPH20; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Dexamethasone
Phase 2: Stage 1 - AG: Nab-paclitaxel + GemcitabineActive comparatorParticipants will receive 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion.
Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Dexamethasone
Phase 2: Stage 2 - PAG: PEGPH20 + Nab-paclitaxel + GemcitabineExperimentalParticipants will receive 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 will be given alone on Days 1 and 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15, and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1, 8, and 15. NAB+GEM will be given 2 to 4 hours after dose of PEGPH20. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to beginning and 8 to 12 hours after completion of each PEGPH20 infusion. Enoxaparin 40 mg/day or 1 mg/kg/day will be given subcutaneously (SC).
Receives: Drug: PEGPH20; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Dexamethasone; Drug: Enoxaparin
Phase 2: Stage 2 - AG: Nab-paclitaxel + GemcitabineActive comparatorParticipants will receive 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. Enoxaparin 40 mg/day or 1 mg/kg/day will be given SC.
Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Dexamethasone; Drug: Enoxaparin

What is being measured

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

  1. Progression-Free Survival (PFS)

    PFS: time from randomization until first occurrence of disease progression, either by central radiologic determination (Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) or by clinical progression determined by Investigator, or death during treatment period from any cause. Radiological disease progression was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 millimeters (mm); Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using Kaplan-Meier (KM) method.

    Measured: From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)

  2. Percentage of Participants in the PAG Arm Who Experienced Any Thromboembolic (TE) Event in Stage 2 of the Study

    TE events were identified by applying the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Queries (SMQ) search strategy for 3 SMQs: TE arterial, TE venous, and TE vessel type unspecified and mixed arterial and venous. TE events were considered by the Sponsor to be adverse events (AEs) of special interest. All TE events, regardless of type of event, severity, or seriousness were reported. Participants with multiple events were counted only once. A summary of serious and all other non-serious adverse events regardless of causality is located in the 'Reported AE section'.

    Measured: From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG)

Secondary outcomes (7)

  1. PFS in Relation to Tumor Hyaluronan (HA) Levels

    PFS was defined as time from randomization until first occurrence of disease progression, either by central radiologic determination (RECIST version 1.1) or by clinical progression determined by Investigator, or death during treatment period from any cause. Disease progression was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 mm; Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using KM method. PFS was measured in HA-high and HA-low participants.

    Measured: From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)

  2. Objective Response Rate (ORR): Percentage of Participants With Objective Response

    ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR) regardless of confirmation, as assessed by RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From the date of randomization until last date on study treatment (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)

  3. Overall Survival

    Overall survival was defined as the time from randomization until death from any cause. Participants who died or were lost to follow-up by the date of analysis data cutoff were censored at their last contact date.

    Measured: From randomization until death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)

  4. Percentage of Participants With AEs

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.

    Measured: From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG and 20.27 months for AG)

  5. Maximum Observed Plasma Concentration (Cmax) of PEGPH20

    Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 pharmacokinetic (PK) were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation [3.5 mg/mL], and Run-in Phase 2: New PEGPH20 formulation [0.3 mg/mL]).

    Measured: Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1

  6. Time to Reach Cmax (Tmax) of PEGPH20

    Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 PK were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation [3.5 mg/mL], and Run-in Phase 2: New PEGPH20 formulation [0.3 mg/mL]).

    Measured: Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1

  7. Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of PEGPH20

    Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 PK were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation [3.5 mg/mL], and Run-in Phase 2: New PEGPH20 formulation [0.3 mg/mL]).

    Measured: Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1

Timeline

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

  1. First posted25 Apr 2013 (estimated)
  2. Study start14 May 2013
  3. Primary completion1 May 2018
  4. Study completion26 Sep 2018

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
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01839487
Sponsor's protocol ID
HALO-109-202
Status last verified
Jul 2020
First submitted
22 Apr 2013
Last updated
20 Jul 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hingorani SR, Zheng L, Bullock AJ, Seery TE, Harris WP, Sigal DS, Braiteh F, Ritch PS, Zalupski MM, Bahary N, Oberstein PE, Wang-Gillam A, Wu W, Chondros D, Jiang P, Khelifa S, Pu J, Aldrich C, Hendifar AE. HALO 202: Randomized Phase II Study of PEGPH20 Plus Nab-Paclitaxel/Gemcitabine Versus Nab-Paclitaxel/Gemcitabine in Patients With Untreated, Metastatic Pancreatic Ductal Adenocarcinoma. J Clin Oncol. 2018 Feb 1;36(4):359-366. doi: 10.1200/JCO.2017.74.9564. Epub 2017 Dec 12.

    PubMed 29232172

  • Wang S, Bager CL, Karsdal MA, Chondros D, Taverna D, Willumsen N. Blood-based extracellular matrix biomarkers as predictors of survival in patients with metastatic pancreatic ductal adenocarcinoma receiving pegvorhyaluronidase alfa. J Transl Med. 2021 Jan 21;19(1):39. doi: 10.1186/s12967-021-02701-z.

    PubMed 33478521

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PEGPH20, Nab-paclitaxel and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Halozyme Therapeutics at 51 sites in United States.

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 13 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 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. 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 20 Jul 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: From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG)). The study lists 2 primary outcomes in all. 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 NCT01839487, 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 20 Jul 2020.

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