Adenocarcinoma of the PancreasPhase 1/2NCT00630552

QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer

A Phase 1/2 study testing AMG 479 and AMG 655 in people with Adenocarcinoma of the Pancreas and Metastatic Pancreatic Cancer, run by NantCell, Inc. at 44 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Adenocarcinoma of the Pancreas, Metastatic Pancreatic Cancer, Pancreatic Cancer
What is being tested?: AMG 479 and AMG 655
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 138 participants
Where: 44 sitesUnited States
Study dates: Jun 2007to Apr 2012
Phase: Phase 1/2
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

Untreated metastatic adenocarcinoma of the pancreas (AJCC Stage IV)
Subjects with unresectable pancreatic cancer who have had surgery are eligible if fully recovered and greater than 30 days have elapsed since the surgery.
Subjects with a history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.
Men or women ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Adequate hematologic, hepatic, renal and coagulation function
Amylase and lipase ≤ 2.0 x ULN
Adequately controlled type 1 or 2 diabetic subjects

Who cannot join

Islet cell, acinar cell carcinoma, non-adenocarcinoma (eg, lymphoma, sarcoma, etc), adenocarcinoma originated from biliary tree or cystadenocarcinoma
Known central nervous system metastases
Uncontrolled cardiac disease or any other co-morbid disease that would increase the risk of toxicity
Adjuvant chemotherapy or chemoradiotherapy

Trial locations and contacts

44 sites in 1 country.

City, postcode or hospital

44 sites in 1 country

United States44 sites

Research Site
Albany, New York, 12206
Research Site
Alhambra, California, 91801
Research Site
Atlanta, Georgia, 30309
Research Site
Atlanta, Georgia, 30341
Research Site
Austin, Texas, 78705
Research Site
Austin, Texas, 78731
Research Site
Austin, Texas, 78745
Research Site
Bakersfield, California, 93309
Research Site
Baltimore, Maryland, 21204
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02115
Research Site
Chicago, Illinois, 60637
Research Site
Columbus, Ohio, 43210
Research Site
Dallas, Texas, 75246
Research Site
Durham, North Carolina, 27710
Research Site
Eugene, Oregon, 97401
Research Site
Fullerton, California, 92835
Research Site
Greenville, South Carolina, 29615
Research Site
Harvey, Illinois, 60426
Research Site
Henderson, Nevada, 89052
Research Site
Hickory, North Carolina, 28602
Research Site
La Jolla, California, 92093
Research Site
Long Beach, California, 90813
Research Site
Los Angeles, California, 90095
Research Site
Marietta, Georgia, 30060
Research Site
Miami, Florida, 33136
Research Site
New York, New York, 10016
Research Site
Northridge, California, 91328
Research Site
Orlando, Florida, 32804
Research Site
Oxnard, California, 93030
Research Site
Philadelphia, Pennsylvania, 19106
Research Site
Pittsburgh, Pennsylvania, 15261
Research Site
Providence, Rhode Island, 02903
Research Site
Rancho Mirage, California, 92270
Research Site
Redondo Beach, California, 90277
Research Site
Round Rock, Texas, 78681
Research Site
San Francisco, California, 94115
Research Site
Santa Maria, California, 93454
Research Site
Santa Monica, California, 90403
Research Site
St Louis, Missouri, 63141
Research Site
Tacoma, Washington, 98405
Research Site
Tyler, Texas, 75702
Research Site
Westminster, Maryland, 21157
Research Site
Yakima, Washington, 98902

Other trials in United States

About this study

Official title: A Phase 1b/2 Study to Evaluate the Safety and Efficacy of AMG 655 or AMG 479 in Combination With Gemcitabine as First-Line Therapy for Metastatic Pancreatic Cancer

This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine as first-line treatment of subjects with metastatic pancreatic cancer. Part 1 is an open-label, dose-escalation phase 1b segment to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with gemcitabine. Enrollment into part 1 of the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo in combination with gemcitabine. The phase 2 segment that will commence after dose selection in part 1. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in combination with gemcitabine.

Conditions: Adenocarcinoma of the Pancreas, Metastatic Pancreatic Cancer, Pancreatic Cancer
Being tested: Placebo, AMG 479, AMG 655
Keywords: AMG 479, Gemcitabine, TR-2, IGF-1R, AMG 655, Pancreatic cancer, Adenocarcinoma of the Pancreas, Metastatic Pancreatic Cancer
Medical subject headings: Pancreatic Neoplasms, Insulin-Like Growth Factor I, Resistance To

What participants receive

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

PlaceboOther
Inactive dummy of AMG 655.
AMG 479Drug
AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
AMG 655Drug
AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).

Study groups in NCT00630552
Study group	Role	What they receive
Phase 1b AMG 655 3mg/kg	Experimental	Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine. Receives: Drug: AMG 655
Phase 1b AMG 655 10mg/kg	Experimental	Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine. Receives: Drug: AMG 655
Phase 2 AMG 655	Experimental	Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion. Receives: Drug: AMG 655
Phase 2 AMG 479	Experimental	Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion. Receives: Drug: AMG 479
Phase 2 AMG 655-placebo	Placebo comparator	Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion. Receives: Other: Placebo

What is being measured

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

Number of Participants With Dose Limiting Toxicities (DLTs; Phase 1b Portion Only)
The incidence of adverse events and clinical laboratory abnormalities defined as DLTs. A DLT was defined as any grade 3 or higher hematologic or non-hematologic toxicity related to any study treatment.
Measured: 28 days
Six Month Overall Survival Rate (Phase 2 Portion Only)
The proportion of subjects alive at 6 months
Measured: 6 months

Secondary outcomes (8)

Objective Response Rate
Objective response was defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors [RECIST] and was determined only for subjects with measurable disease at baseline. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From start of study treatment through up to 36 months
Progression-free Survival (PFS)
PFS was defined as the time from study day 1 (phase 1b portion) or randomization (phase 2 portion) to the first observation of disease progression per investigator review (as classified by modified RECIST or clinical progression, whichever occurred first) or death due to any cause, or censoring. 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 start of study treatment through up to 36 months
Overall Survival
Overall survival was defined as the time from study day 1 (phase 1b portion) or randomization (phase 2 portion) to death for any cause.
Measured: From start of study treatment through up to 36 months
Number of Subjects With an Adverse Event
Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) Version 3.0
Measured: From start of study treatment through up to 44 weeks
Pharmacokinetics of AMG 655, Ganitumab, and Gemcitabine
PK parameter of Cmax for AMG 655 (phase 1b and phase 2 portions) - pg 266, ganitumab (phase 2 portion only) - pg 270 , and gemcitabine (phase 1b portion only - pg 272) PK parameters
Measured: From start of study treatment through up to 48 weeks
Dose Intensity of Gemcitabine (Phase 2 Portion Only)
Average Dose intensity of gemcitabine when combined with AMG 655, placebo or AMG 479
Measured: From start of study treatment through up to 40 weeks
Duration of Response
Duration of response was the time from the first observation of an objective response to the subsequent time of disease progression (per modified RECIST or clinical progression, whichever came first) or death due to any cause. Objective response = a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors [RECIST]. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From objective response through up to 36 months
Incidence of Antibody Formation
The incidence of antibody formation of anti-AMG 655 (phase 1b and phase 2 portions) or anti- ganitumab (phase 2 portion only)
Measured: From start of treatment up to 40 weeks

Timeline

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

Jun 2007Apr 2012

First posted7 Mar 2008 (estimated)
Study startJun 2007
Primary completionJan 2010
Study completionApr 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 (5)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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00630552
Sponsor's protocol ID: 20060323
Other IDs: QUILT-2.019
Status last verified: Oct 2024
First submitted: 28 Feb 2008
Last updated: 17 Oct 2024
Results posted: Yes, on ClinicalTrials.gov

Publications

Cella D, Butt Z, Kindler HL, Fuchs CS, Bray S, Barlev A, Oglesby A. Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer. Qual Life Res. 2013 Jun;22(5):1105-12. doi: 10.1007/s11136-012-0217-4. Epub 2012 Jun 8.
PubMed 22678353
Kindler HL, Richards DA, Garbo LE, Garon EB, Stephenson JJ Jr, Rocha-Lima CM, Safran H, Chan D, Kocs DM, Galimi F, McGreivy J, Bray SL, Hei Y, Feigal EG, Loh E, Fuchs CS. A randomized, placebo-controlled phase 2 study of ganitumab (AMG 479) or conatumumab (AMG 655) in combination with gemcitabine in patients with metastatic pancreatic cancer. Ann Oncol. 2012 Nov;23(11):2834-2842. doi: 10.1093/annonc/mds142. Epub 2012 Jun 13.
PubMed 22700995
Lu, JF.Exposure-response analysis to facilitate phase 3 dose selection for Ganitumumab (AMG 479) in combination with Gemcitabine to treat metastatic pancreatic cancer.Journal-000728;
McCaffery I, Tudor Y, Deng H, Tang R, Suzuki S, Badola S, Kindler HL, Fuchs CS, Loh E, Patterson SD, Chen L, Gansert JL. Putative predictive biomarkers of survival in patients with metastatic pancreatic adenocarcinoma treated with gemcitabine and ganitumab, an IGF1R inhibitor. Clin Cancer Res. 2013 Aug 1;19(15):4282-9. doi: 10.1158/1078-0432.CCR-12-1840. Epub 2013 Jun 5.
PubMed 23741071
TBD.Validation of the FACT-hepatobiliary questionnaire in metastatic pancreatic cancer population.Journal-004521;

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

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All Adenocarcinoma of the Pancreas trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b/2 Study to Evaluate the Safety and Efficacy of AMG 655 or AMG 479 in Combination With Gemcitabine as First-Line Therapy for Metastatic Pancreatic Cancer
ClinicalTrials.gov ID: NCT00630552
Acronym / sponsor ID: 20060323
Conditions: Adenocarcinoma of the Pancreas, Metastatic Pancreatic Cancer, Pancreatic Cancer
Keywords: AMG 479, Gemcitabine, TR-2, IGF-1R, AMG 655, Pancreatic cancer, Adenocarcinoma of the Pancreas, Metastatic Pancreatic Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: NantCell, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Jan 2010 (actual)
Study completion: Apr 2012 (actual)
First posted: 7 Mar 2008 (estimated)
Results: Posted 17 Oct 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: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Phase 1b AMG 655 3mg/kg	Experimental	Drug: AMG 655Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
Phase 1b AMG 655 10mg/kg	Experimental	Drug: AMG 655Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
Phase 2 AMG 655	Experimental	Drug: AMG 655Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
Phase 2 AMG 479	Experimental	Drug: AMG 479Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
Phase 2 AMG 655-placebo	Placebo comparator	Other: PlaceboSubjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.

Who may qualify

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

Key inclusion criteria (8 listed)

Untreated metastatic adenocarcinoma of the pancreas (AJCC Stage IV)
Subjects with unresectable pancreatic cancer who have had surgery are eligible if fully recovered and greater than 30 days have elapsed since the surgery.
Subjects with a history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.
Men or women ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

Key exclusion criteria (4 listed)

Islet cell, acinar cell carcinoma, non-adenocarcinoma (eg, lymphoma, sarcoma, etc), adenocarcinoma originated from biliary tree or cystadenocarcinoma
Known central nervous system metastases
Uncontrolled cardiac disease or any other co-morbid disease that would increase the risk of toxicity
Adjuvant chemotherapy or chemoradiotherapy

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
PlaceboInactive dummy of AMG 655.	Other	Phase 2 AMG 655-placebo
AMG 479AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).	Drug	Phase 2 AMG 479
AMG 655AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).	Drug	Phase 1b AMG 655 10mg/kg, Phase 1b AMG 655 3mg/kg, Phase 2 AMG 655

Primary outcome

Number of Participants With Dose Limiting Toxicities (DLTs; Phase 1b Portion Only)
Time frame: 28 days
The incidence of adverse events and clinical laboratory abnormalities defined as DLTs. A DLT was defined as any grade 3 or higher hematologic or non-hematologic toxicity related to any study treatment.
Six Month Overall Survival Rate (Phase 2 Portion Only)
Time frame: 6 months
The proportion of subjects alive at 6 months

8 secondary outcomes

Objective Response Rate
Time frame: From start of study treatment through up to 36 months
Progression-free Survival (PFS)
Time frame: From start of study treatment through up to 36 months
Overall Survival
Time frame: From start of study treatment through up to 36 months
Number of Subjects With an Adverse Event
Time frame: From start of study treatment through up to 44 weeks
Pharmacokinetics of AMG 655, Ganitumab, and Gemcitabine
Time frame: From start of study treatment through up to 48 weeks
Dose Intensity of Gemcitabine (Phase 2 Portion Only)
Time frame: From start of study treatment through up to 40 weeks
Duration of Response
Time frame: From objective response through up to 36 months
Incidence of Antibody Formation
Time frame: From start of treatment up to 40 weeks

Results and safety

Results posted to the registry on 17 Oct 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
Phase 1b AMG 655 3mg/kg	6	1
Phase 1b AMG 655 10mg/kg	7	0
Phase 2 AMG 655	41	4
Phase 2 AMG 479	42	8
Phase 2 AMG 655-placebo	42	3

Primary outcome: Number of Participants With Dose Limiting Toxicities (DLTs; Phase 1b Portion Only)

Time frame: 28 days. Count of participants. Unit: Participants

Measure	Phase 1b AMG 655 3mg/kg n = 6	Phase 1b AMG 655 10mg/kg n = 7
Value	0	0

Population analysed: The DLT analysis set consisted of subjects in the phase 1b portion of the study only, who experienced at least 1 DLT in the first 28 days of treatment or received 2 doses of AMG 655, 3 infusions of gemcitabine in a 28 day cycle at doses not less than 750 mg/m2 and were followed for at least 28 days (with or without DLTs).

Primary outcome: Six Month Overall Survival Rate (Phase 2 Portion Only)

Time frame: 6 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Phase 2 AMG 655 n = 41	Phase 2 AMG 479 n = 42	Phase 2 AMG 655-placebo n = 42
Value	59.2 (42.3 to 72.7)	56.6 (40.8 to 69.7)	49.5 (33.4 to 63.7)

Population analysed: Full analysis (The full analysis set consisted of all randomized subjects in the phase 2 portion of the study, with subjects analyzed according to the randomized treatment.)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1b AMG 655 3mg/kg	4 of 6 (66.7%)	6 of 6 (100%)	5 of 6
Phase 1b AMG 655 10mg/kg	4 of 7 (57.1%)	7 of 7 (100%)	7 of 7
Phase 2 AMG 655	23 of 41 (56.1%)	41 of 41 (100%)	32 of 41
Phase 2 AMG 479	21 of 40 (52.5%)	39 of 40 (97.5%)	28 of 42
Phase 2 AMG 655-placebo	20 of 40 (50%)	40 of 40 (100%)	33 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22678353Cella D, Butt Z, Kindler HL, Fuchs CS, Bray S, Barlev A, Oglesby A. Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer. Qual Life Res. 2013 Jun;22(5):1105-12. doi: 10.1007/s11136-012-0217-4. Epub 2012 Jun 8.
Background: PubMed 22700995Kindler HL, Richards DA, Garbo LE, Garon EB, Stephenson JJ Jr, Rocha-Lima CM, Safran H, Chan D, Kocs DM, Galimi F, McGreivy J, Bray SL, Hei Y, Feigal EG, Loh E, Fuchs CS. A randomized, placebo-controlled phase 2 study of ganitumab (AMG 479) or conatumumab (AMG 655) in combination with gemcitabine in patients with metastatic pancreatic cancer. Ann Oncol. 2012 Nov;23(11):2834-2842. doi: 10.1093/annonc/mds142. Epub 2012 Jun 13.
BackgroundLu, JF.Exposure-response analysis to facilitate phase 3 dose selection for Ganitumumab (AMG 479) in combination with Gemcitabine to treat metastatic pancreatic cancer.Journal-000728;
Background: PubMed 23741071McCaffery I, Tudor Y, Deng H, Tang R, Suzuki S, Badola S, Kindler HL, Fuchs CS, Loh E, Patterson SD, Chen L, Gansert JL. Putative predictive biomarkers of survival in patients with metastatic pancreatic adenocarcinoma treated with gemcitabine and ganitumab, an IGF1R inhibitor. Clin Cancer Res. 2013 Aug 1;19(15):4282-9. doi: 10.1158/1078-0432.CCR-12-1840. Epub 2013 Jun 5.
BackgroundTBD.Validation of the FACT-hepatobiliary questionnaire in metastatic pancreatic cancer population.Journal-004521;
AmgenTrials clinical trials websiteLink 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

44 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AMG 479 and AMG 655 in people with Adenocarcinoma of the Pancreas and Metastatic Pancreatic Cancer, run by NantCell, Inc. at 44 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 4 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 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 17 Oct 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?

Number of Participants With Dose Limiting Toxicities (DLTs; Phase 1b Portion Only) (time frame: 28 days). 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 NCT00630552, which also lists 5 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 17 Oct 2024.