Adenocarcinoma of the PancreasPhase 2NCT01318642
Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas
A Phase 2 study testing Gemcitabine and AMG 479 in people with Adenocarcinoma of the Pancreas and Locally Advanced, run by NantBioScience, Inc. at 35 sites in 13 countries.
Trial summary
This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Pancreas, Locally Advanced, Unresectable
- What is being tested?
- Gemcitabine and AMG 479
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 35 sitesin 13 countries
- Study dates
- 31 May 2012to 3 Dec 2012
- 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
- Subjects must have histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is unresectable, per institutional practice
- Radiologically measurable and/or non-measurable disease as defined by RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Men or women >/= 18 years of age
- Adequate organ function
Who cannot join
- Early (stage I) or metastatic (stage IV) disease
- Islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma, sarcoma, etc), adenocarcinoma originating from biliary tree or cystadenocarcinoma
- External biliary drain
- Currently treated or previously treated with biologic, small molecule, immunotherapy, chemotherapy (ie, including gemcitabine), or other agents for pancreatic cancer
- Currently treated or previously treated with radiotherapy, or chemoradiotherapy for pancreatic cancer
Trial locations and contacts
35 sites in 13 countries.
35 sites in 13 countries
Hungary4 sites
Research Site
Budapest, 1097
Research Site
Debrecen, 4012
Research Site
Miskolc, 3526
Research Site
Szolnok, 5004
Russia4 sites
Research Site
Chelyabinsk, 454087
Research Site
Moscow, 115478
Research Site
Saint Petersburg, 197022
Research Site
Samara, 443031
South Korea4 sites
Research Site
Seoul, 120-752
Research Site
Seoul, 135-710
Research Site
Seoul, 138-736
Research Site
Seoul, 152-703
Austria3 sites
Research Site
Salzburg, 5020
Research Site
Steyr, 4400
Research Site
Vienna, 1090
Czechia3 sites
Research Site
Hradec Králové, 500 05
Research Site
Olomouc, 775 20
Research Site
Prague, 100 34
Poland3 sites
Research Site
Lodz, 93-509
Research Site
Poznan, 60-569
Research Site
Warsaw, 02-097
Spain3 sites
Research Site
Barcelona, Cataluña, 08035
Research Site
Madrid, 28034
Research Site
Madrid, 28050
United Kingdom3 sites
Guys Hospital
London, SE1 9RT
Research Site
London, W12 0HS
Research Site
Preston, PR2 9HT
United States2 sites
Research Site
Knoxville, Tennessee, 37909
Research Site
San Francisco, California, 94115
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of AMG 479 or Placebo in Combination With Gemcitabine as First-line Therapy for Locally Advanced Unresectable Adenocarcinoma of the Pancreas
This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1).
Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.
Read the detailed description
This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1).
Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.
- Being tested
- Gemcitabine, AMG 479, Placebo
- Keywords
- Adenocarcinoma, pancreas, pancreatic cancer, local, unresectable, stage II, stage III
- Medical subject headings
- Adenocarcinoma, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
AMG 479Drug
Also called gemcitabine = Gemzar
Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
PlaceboDrug
Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Gemcitabine | Active comparator | Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle Receives: Drug: Gemcitabine; Drug: Placebo |
| AMG 479 20 mg/kg + Gemcitabine | Experimental | ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle. Receives: Drug: Gemcitabine; Drug: AMG 479 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint is Progression-free Survival (PFS) as Defined as the Time From Randomization to Progression (Per RECIST v1.1) or Death.
The time from randomization to progression (per RECIST version 1.1) or death from any cause. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Measured: From randomization to the date of either disease progression or death, up to 181 days progression or death
Secondary outcomes (5)
Overall Survival
OS - time from study day 1 to death (by any cause)
Measured: Up to 181 days
Number of Participants With Adverse Events
Measured via CTCAE v3.0
Measured: Up to 4 months
Progression Free Survival Rate and Overall Survival Rate at at 3 and 6 Months, Objective Response Rate, Disease Control Rate
PFS rates - subjects with disease progression (PD) or death at the timepoint; OS rates - subjects alive at the timepoint; ORR - tumor response assessment of either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST); DCR - subjects with PR, CR, or SD Per RECIST: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Disease progression=at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study; stable disease is disease that is not partial or progressed
Measured: Up to 181 days
Duration of Response
DOR - time from the first observation of an objective response (subjects with CR or PR) to the time of PD or death; Per RECIST: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Disease progression=at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study; stable disease is disease that is not partial or progressed
Measured: Up to 181 days
Number of Participants With Anti-AMG 479 Antibodies
post-dose anti-AMG 479 antibody positive rate
Measured: Up to 181 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study start31 May 2012
- Primary completion27 Nov 2012
- Study completion3 Dec 2012
Why it stopped: NCT01318642: Planned independent DMC Interim review: ended for futility
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NantBioScience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318642
- Sponsor's protocol ID
- 20080261
- Other IDs
- 2010-023978-39
- Status last verified
- May 2024
- First submitted
- 17 Mar 2011
- Last updated
- 8 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of AMG 479 or Placebo in Combination With Gemcitabine as First-line Therapy for Locally Advanced Unresectable Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT01318642
- Acronym / sponsor ID
- 20080261
- Keywords
- Adenocarcinoma, pancreas, pancreatic cancer, local, unresectable, stage II, stage III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: NCT01318642: Planned independent DMC Interim review: ended for futility
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NantBioScience, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2012 (actual)
- Primary completion
- 27 Nov 2012 (actual)
- Study completion
- 3 Dec 2012 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Posted 8 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1).
Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.
Detailed description
This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1).
Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo + Gemcitabine | Active comparator | Drug: Gemcitabine, Drug: PlaceboArm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle |
| AMG 479 20 mg/kg + Gemcitabine | Experimental | Drug: Gemcitabine, Drug: AMG 479ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/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 (5 listed)
- Subjects must have histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is unresectable, per institutional practice
- Radiologically measurable and/or non-measurable disease as defined by RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Men or women >/= 18 years of age
- Adequate organ function
Key exclusion criteria (5 listed)
- Early (stage I) or metastatic (stage IV) disease
- Islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma, sarcoma, etc), adenocarcinoma originating from biliary tree or cystadenocarcinoma
- External biliary drain
- Currently treated or previously treated with biologic, small molecule, immunotherapy, chemotherapy (ie, including gemcitabine), or other agents for pancreatic cancer
- Currently treated or previously treated with radiotherapy, or chemoradiotherapy for pancreatic cancer
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 |
|---|---|---|
| GemcitabineAlso: GemzarGemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle. | Drug | AMG 479 20 mg/kg + Gemcitabine, Placebo + Gemcitabine |
| AMG 479Also: gemcitabine = GemzarGemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle. | Drug | AMG 479 20 mg/kg + Gemcitabine |
| PlaceboGemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle | Drug | Placebo + Gemcitabine |
Primary outcome
The Primary Endpoint is Progression-free Survival (PFS) as Defined as the Time From Randomization to Progression (Per RECIST v1.1) or Death.
Time frame: From randomization to the date of either disease progression or death, up to 181 days progression or death
The time from randomization to progression (per RECIST version 1.1) or death from any cause. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
5 secondary outcomes
Overall Survival
Time frame: Up to 181 days
Number of Participants With Adverse Events
Time frame: Up to 4 months
Progression Free Survival Rate and Overall Survival Rate at at 3 and 6 Months, Objective Response Rate, Disease Control Rate
Time frame: Up to 181 days
Duration of Response
Time frame: Up to 181 days
Number of Participants With Anti-AMG 479 Antibodies
Time frame: Up to 181 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
MD study director
Amgen
35 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine and AMG 479 in people with Adenocarcinoma of the Pancreas and Locally Advanced, run by NantBioScience, Inc. at 35 sites in 13 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Hungary, Russia, South Korea, Austria, Czechia and 8 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 8 Nov 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?
The Primary Endpoint is Progression-free Survival (PFS) as Defined as the Time From Randomization to Progression (Per RECIST v1.1) or Death. (time frame: From randomization to the date of either disease progression or death, up to 181 days progression or death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2024.