Adenocarcinoma of the PancreasPhase 3GAMMANCT01231347

QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas

A Phase 3 study testing AMG 479 and gemcitabine in people with Adenocarcinoma of the Pancreas and Advanced Solid Tumors, run by NantCell, Inc. at 152 sites in 32 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Adenocarcinoma of the Pancreas, Advanced Solid Tumors, Cancer
What is being tested?: AMG 479 and gemcitabine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 800 participants
Where: 152 sitesin 32 countries
Study dates: 7 Apr 2011to 12 Dec 2012
Phase: Phase 3
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

Untreated metastatic adenocarcinoma of the pancreas
Adequate hematologic, renal and liver function
Eastern Cooperative Oncology Group (ECOG) 0 or 1

Who cannot join

Prior chemotherapy or radiotherapy for pancreatic cancer
Central nervous system metastases
External biliary drain

Trial locations and contacts

152 sites in 32 countries.

Country

City, postcode or hospital

152 sites in 32 countries

United States24 sites

Research Site
Abingdon, Virginia, 24211
Research Site
Bend, Oregon, 97701
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02215
Research Site
Charleston, South Carolina, 29425
Research Site
Chicago, Illinois, 60637
Research Site
Detroit, Michigan, 48201
Research Site
Durham, North Carolina, 27710
Research Site
Fort Worth, Texas, 76177
Research Site
Fullerton, California, 92835
Research Site
Grand Rapids, Michigan, 49503
Research Site
Harvey, Illinois, 60426
Research Site
Knoxville, Tennessee, 37909
Research Site
La Jolla, California, 92093-0957
Research Site
Los Angeles, California, 90095-1772
Research Site
Los Angeles, California, 90095
Research Site
Paris, Texas, 75460-5004
Research Site
Providence, Rhode Island, 02903
Research Site
Providence, Rhode Island, 02906
Research Site
Quincy, Illinois, 62301
Research Site
Rancho Mirage, California, 92270
Research Site
Redondo Beach, California, 90277
Research Site
Santa Maria, California, 93454
Research Site
Spokane Valley, Washington, 99216

Other trials in United States

Spain8 sites

Research Site
Badalona, CataluÃ±a, 08916
Research Site
Barcelona, CataluÃ±a, 08035
Research Site
Barcelona, CataluÃ±a, 08036
Research Site
Elche, Valencia, 03203
Research Site
Madrid, 28034
Research Site
Madrid, 28050
Research Site
Santander, Cantabria, 39008
Research Site
Valencia, Valencia, 46010

Other trials in Spain

Germany7 sites

Research Site
Berlin, 13353
Research Site
Dresden, 01307
Research Site
Halle, 06120
Research Site
Mainz, 55131
Research Site
Mannheim, 68167
Research Site
Marburg, 35043
Research Site
Villingen-Schwenningen, 78050

Other trials in Germany

Poland7 sites

Research Site
Gdansk, 80-952
Research Site
Konin, 62-500
Research Site
Lodz, 93-509
Research Site
Poznan, 61-485
Research Site
Warsaw, 02-097
Research Site
Warsaw, 04-125
Research Site
Warsaw, 04-141

Other trials in Poland

Australia6 sites

Research Site
Bentleigh East, Victoria, 3165
Research Site
Kogarah, New South Wales, 2217
Research Site
Kurralta Park, South Australia, 5037
Research Site
Parkville, Victoria, 3050
Research Site
South Brisbane, Queensland, 4101
Research Site
Woodville South, South Australia, 5011

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Belgium6 sites

Research Site
Brussels, 1070
Research Site
Charleroi, 6000
Research Site
Edegem, 2650
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Research Site
Libramont, 6800

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Czechia6 sites

Research Site
Brno, 656 53
Research Site
Brno, 656 91
Research Site
Hradec Králové, 500 05
Research Site
Olomouc, 775 20
Research Site
Prague, 128 08
Research Site
Prague, 150 06

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United Kingdom6 sites

Research Site
Belfast, BT9 7AB
Research Site
Birmingham, B9 5SS
Research Site
Cottingham, HU16 5JQ
Research Site
Leicester, LE1 5WW
Research Site
Manchester, M20 4BX
Research Site
Northampton, NN1 5BD

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Canada5 sites

Research Site
Oshawa, Ontario, L1G 2B9
Research Site
Ottawa, Ontario, K1H 8L6
Research Site
Québec, Quebec, G1R 2J6
Research Site
Toronto, Ontario, M5G 2M9
Research Site
Vancouver, British Columbia, V5Z 4E6

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Hungary5 sites

Research Site
Budapest, 1062
Research Site
Budapest, 1097
Research Site
Debrecen, 4012
Research Site
Győr, 9023
Research Site
Miskolc, 3526

Other trials in Hungary

Japan5 sites

Research Site
Kashiwa, Chiba, 277-8577
Research Site
Mitaka, Tokyo, 181-8611
Research Site
Nagoya, Aichi-ken, 464-8681
Research Site
Tokyo, 104-0045
Research Site
Yokohama, Kanagawa, 241-0815

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Portugal5 sites

Research Site
Barreiro, 2830-094
Research Site
Lisbon, 1099-023
Research Site
Lisbon, 1649-035
Research Site
Porto, 4200-072
Research Site
Porto, 4200-319

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Slovakia5 sites

Research Site
Bardejov, 085 01
Research Site
Bratislava, 833 10
Research Site
Košice, 041 91
Research Site
Nitra, 950 01
Research Site
Poprad, 058 01

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South Korea5 sites

Research Site
Seoul, 110-744
Research Site
Seoul, 120-752
Research Site
Seoul, 135-710
Research Site
Seoul, 138-736
Research Site
Seoul, 152-703

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Austria4 sites

Research Site
Innsbruck, 6020
Research Site
Salzburg, 5020
Research Site
Steyr, 4400
Research Site
Vienna, 1090

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Bulgaria4 sites

Research Site
Sofia, 1527
Research Site
Sofia, 1606
Research Site
Sofia, 1756
Research Site
Varna, 9010

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Greece4 sites

Research Site
Athens, 11527
Research Site
Heraklion, 71110
Research Site
Pátrai, 26500
Research Site
Thessaloniki, 56429

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Netherlands4 sites

Research Site
Amsterdam, 1081 HV
Research Site
Eindhoven, 5623 EJ
Research Site
Groningen, 9713 GZ
Research Site
Leiden, 2333 ZA

Other trials in Netherlands

Denmark3 sites

Research Site
Aalborg, 9000
Research Site
Herlev, 2730
Research Site
Odense, 5000

Other trials in Denmark

Finland3 sites

Research Site
Lahti, 15850
Research Site
Tampere, 33521
Research Site
Turku, 20521

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France3 sites

Research Site
Brest, 29609
Research Site
Clermont-Ferrand, 63003
Research Site
Pessac, 33604

Other trials in France

Hong Kong3 sites

Research Site
Kowloon
Research Site
Shatin
Research Site
Tuenmen

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Italy3 sites

Research Site
Genova, 16132
Research Site
Messina, 98125
Research Site
Naples, 80131

Other trials in Italy

Romania3 sites

Research Site
Bucharest, 022328
Research Site
Cluj-Napoca, 400015
Research Site
Sibiu, 550245

Other trials in Romania

Russia3 sites

Research Site
Moscow, 115478
Research Site
Moscow, 119992
Research Site
Saint Petersburg, 191104

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Serbia3 sites

Research Site
Belgrade, 11000
Research Site
Belgrade, 11080
Research Site
Kamenitz, 21204

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Switzerland3 sites

Research Site
Basel, 4031
Research Site
Geneva, 1211
Research Site
Winterthur, 8401

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Brazil2 sites

Research Site
Porto Alegre, Rio Grande do Sul, 90035-003
Research Site
Salvador, Estado de Bahia, 40050-410

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Lithuania2 sites

Research Site
Kaunas, 50009
Research Site
Vilnius, 08660

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Slovenia2 sites

Research Site
Ljubljana, 1000
Research Site
Ljubljana, 1525

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Sweden2 sites

Research Site
Eskilstuna, 631 88
Research Site
Uppsala, 751 85

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Taiwan1 site

Research Site
Taipei City, Taipei, 10002

Other trials in Taiwan

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas

AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival. The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.

Conditions: Adenocarcinoma of the Pancreas, Advanced Solid Tumors, Cancer, Cancer of Pancreas, Cancer of the Pancreas, Metastases
Being tested: AMG 479, Placebo, gemcitabine
Keywords: pancreas, gemcitabine, metastatic, jaundice
Medical subject headings: Neoplasms, Pancreatic Neoplasms, Neoplasm Metastasis, Endocrine Gland Neoplasms, Jaundice

What participants receive

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

AMG 479Drug
AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
PlaceboDrug
Placebo administered intravenously on days 1 and 15 of a 28 day cycle
AMG 479Drug
AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
gemcitabineDrug
Also called Gemzar
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle

Study groups in NCT01231347
Study group	Role	What they receive
Placebo + gemcitabine	Placebo comparator	Arm 1: AMG 479-placebo IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle Receives: Drug: Placebo; Drug: gemcitabine
AMG 479 12 mg/kg dose + gemcitabine	Experimental	Arm 2: AMG 479 12 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle Receives: Drug: AMG 479; Drug: gemcitabine
AMG 479 20 mg/kg + gemcitabine	Experimental	Arm 3: AMG 479 20 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle Receives: Drug: AMG 479; Drug: gemcitabine

What is being measured

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

Determine if the Treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in Combination With Gemcitabine Improves Overall Survival as Compared With Placebo in Combination With Gemcitabine in Subjects With Metastatic Adenocarcinoma of the Pancreas
The primary endpoint of the study was OS, defined as the time from randomization to death.
Measured: From randomization up to 20 months

Timeline

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

7 Apr 201112 Dec 2012

First posted1 Nov 2010 (estimated)
Study start7 Apr 2011
Primary completion12 Dec 2012
Study completion12 Dec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Adenocarcinoma of the PancreasStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 800 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01231347
Sponsor's protocol ID: 20060540
Other IDs: 20060540, GAMMA, QUILT-2.014
Acronym: GAMMA
Status last verified: Jun 2024
First submitted: 14 Oct 2010
Last updated: 16 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fuchs CS, Azevedo S, Okusaka T, Van Laethem JL, Lipton LR, Riess H, Szczylik C, Moore MJ, Peeters M, Bodoky G, Ikeda M, Melichar B, Nemecek R, Ohkawa S, Swieboda-Sadlej A, Tjulandin SA, Van Cutsem E, Loberg R, Haddad V, Gansert JL, Bach BA, Carrato A. A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. Ann Oncol. 2015 May;26(5):921-927. doi: 10.1093/annonc/mdv027. Epub 2015 Jan 21.
PubMed 25609246

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic

All Adenocarcinoma of the Pancreas trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas
ClinicalTrials.gov ID: NCT01231347
Acronym / sponsor ID: GAMMA / 20060540
Conditions: Adenocarcinoma of the Pancreas, Advanced Solid Tumors, Cancer, Cancer of Pancreas, Cancer of the Pancreas, Metastases
Keywords: pancreas, gemcitabine, metastatic, jaundice
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 800 participants (actual)
Lead sponsor: NantCell, Inc.Industry (pharma, biotech, devices)
Collaborators: Takeda
Study start: 7 Apr 2011 (actual)
Primary completion: 12 Dec 2012 (actual)
Study completion: 12 Dec 2012 (actual)
First posted: 1 Nov 2010 (estimated)
Results: Posted 16 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo + gemcitabine	Placebo comparator	Drug: Placebo, Drug: gemcitabineArm 1: AMG 479-placebo IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle
AMG 479 12 mg/kg dose + gemcitabine	Experimental	Drug: AMG 479, Drug: gemcitabineArm 2: AMG 479 12 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle
AMG 479 20 mg/kg + gemcitabine	Experimental	Drug: AMG 479, Drug: gemcitabineArm 3: AMG 479 20 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Untreated metastatic adenocarcinoma of the pancreas
Adequate hematologic, renal and liver function
Eastern Cooperative Oncology Group (ECOG) 0 or 1

Key exclusion criteria (3 listed)

Prior chemotherapy or radiotherapy for pancreatic cancer
Central nervous system metastases
External biliary drain

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AMG 479AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle	Drug	AMG 479 12 mg/kg dose + gemcitabine
PlaceboPlacebo administered intravenously on days 1 and 15 of a 28 day cycle	Drug	Placebo + gemcitabine
AMG 479AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle	Drug	AMG 479 20 mg/kg + gemcitabine
gemcitabineAlso: Gemzargemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle	Drug	AMG 479 12 mg/kg dose + gemcitabine, AMG 479 20 mg/kg + gemcitabine, Placebo + gemcitabine

Primary outcome

Determine if the Treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in Combination With Gemcitabine Improves Overall Survival as Compared With Placebo in Combination With Gemcitabine in Subjects With Metastatic Adenocarcinoma of the Pancreas
Time frame: From randomization up to 20 months
The primary endpoint of the study was OS, defined as the time from randomization to death.

Results and safety

Results posted to the registry on 16 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo + Gemcitabine	322	90
AMG 479 12 mg/kg Dose + Gemcitabine	318	78
AMG 479 20 mg/kg + Gemcitabine	160	43

Primary outcome: Determine if the Treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in Combination With Gemcitabine Improves Overall Survival as Compared With Placebo in Combination With Gemcitabine in Subjects With Metastatic Adenocarcinoma of the Pancreas

Time frame: From randomization up to 20 months. Median (95% Confidence Interval). Unit: months

Measure	AMG 479 12 mg/kg Dose + Gemcitabine n = 318	AMG 479 20 mg/kg + Gemcitabine n = 160	Placebo + Gemcitabine n = 322
Value	7.0 (6.2 to 8.5)	7.1 (6.4 to 8.5)	7.2 (6.3 to 8.2)

Population analysed: Full analysis set =all randomized subjects

Adverse events

Time frame: Adverse events were collected from screening through 30 days after the last dose of last protocol specified therapy, up to 20 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo + Gemcitabine	33 of 317 (10.4%)	312 of 317 (98.4%)	202 of 322
AMG 479 12 mg/kg Dose + Gemcitabine	30 of 315 (9.5%)	308 of 315 (97.8%)	210 of 318
AMG 479 20 mg/kg + Gemcitabine	18 of 160 (11.3%)	159 of 160 (99.4%)	101 of 160

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25609246Fuchs CS, Azevedo S, Okusaka T, Van Laethem JL, Lipton LR, Riess H, Szczylik C, Moore MJ, Peeters M, Bodoky G, Ikeda M, Melichar B, Nemecek R, Ohkawa S, Swieboda-Sadlej A, Tjulandin SA, Van Cutsem E, Loberg R, Haddad V, Gansert JL, Bach BA, Carrato A. A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. Ann Oncol. 2015 May;26(5):921-927. doi: 10.1093/annonc/mdv027. Epub 2015 Jan 21.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Related InfoLink provided by the sponsor.

Related trials for Adenocarcinoma of the Pancreas

RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

NantKWest Clinical Review Team principal investigator

ImmunityBio, Inc.

152 sites in 32 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AMG 479 and gemcitabine in people with Adenocarcinoma of the Pancreas and Advanced Solid Tumors, run by NantCell, Inc. at 152 sites in 32 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 3 inclusion and 3 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 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in United States, Spain, Germany, Poland, Australia and 27 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 16 Jul 2024). 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?

Determine if the Treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in Combination With Gemcitabine Improves Overall Survival as Compared With Placebo in Combination With Gemcitabine in Subjects With Metastatic Adenocarcinoma of the Pancreas (time frame: From randomization up to 20 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 NCT01231347, 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 16 Jul 2024.