Trial · NCT01231347

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

NCT01231347, Phase 3, Completed, NantCell, Inc.; results first posted 2024-07-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas. Trials, record NCT01231347. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01231347

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas
NCT number: NCT01231347
Status: Completed
Phases: Phase 3
Enrollment: 800 participants, actual
Lead sponsor: NantCell, Inc.
Conditions: Adenocarcinoma of the Pancreas, Advanced Solid Tumors, Cancer, Cancer of Pancreas, Cancer of the Pancreas, Metastases, Metastatic Cancer, Metastatic Pancreatic Cancer, Pancreas Cancer, Pancreatic Cancer, Bone Metastases, Endocrine Cancer, Oncology, Oncology Patients, Solid Tumors, Advanced Malignancy
Interventions: AMG 479, Placebo, AMG 479, gemcitabine
First posted: 2010-11-01
Last updated: 2024-07-16
Results first posted: 2024-07-16

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	From randomization up to 20 months	The primary endpoint of the study was OS, defined as the time from randomization to death.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	From randomization up to 20 months	Full analysis set =all randomized subjects	months	MEDIAN

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
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	AMG 479 12 mg/kg Dose + Gemcitabine	7.0	95% Confidence Interval 6.2 to 8.5	months
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	AMG 479 20 mg/kg + Gemcitabine	7.1	95% Confidence Interval 6.4 to 8.5	months
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	Placebo + Gemcitabine	7.2	95% Confidence Interval 6.3 to 8.2	months

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo + Gemcitabine	322
Overall Study	STARTED	AMG 479 12 mg/kg Dose + Gemcitabine	318
Overall Study	STARTED	AMG 479 20 mg/kg + Gemcitabine	160
Overall Study	COMPLETED	Placebo + Gemcitabine	90
Overall Study	COMPLETED	AMG 479 12 mg/kg Dose + Gemcitabine	78
Overall Study	COMPLETED	AMG 479 20 mg/kg + Gemcitabine	43
Overall Study	NOT COMPLETED	Placebo + Gemcitabine	232
Overall Study	NOT COMPLETED	AMG 479 12 mg/kg Dose + Gemcitabine	240
Overall Study	NOT COMPLETED	AMG 479 20 mg/kg + Gemcitabine	117

Source ClinicalTrials.gov

Adverse events192

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Placebo + Gemcitabine	128	317
other	Nausea	Gastrointestinal disorders	AMG 479 12 mg/kg Dose + Gemcitabine	133	315
other	Nausea	Gastrointestinal disorders	AMG 479 20 mg/kg + Gemcitabine	71	160
other	Neutropenia	Blood and lymphatic system disorders	Placebo + Gemcitabine	109	317
other	Neutropenia	Blood and lymphatic system disorders	AMG 479 12 mg/kg Dose + Gemcitabine	117	315
other	Neutropenia	Blood and lymphatic system disorders	AMG 479 20 mg/kg + Gemcitabine	52	160
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo + Gemcitabine	94	317
other	Thrombocytopenia	Blood and lymphatic system disorders	AMG 479 12 mg/kg Dose + Gemcitabine	126	315
other	Thrombocytopenia	Blood and lymphatic system disorders	AMG 479 20 mg/kg + Gemcitabine	54	160
other	Fatigue	General disorders	Placebo + Gemcitabine	93	317

1 to 10 of 192Source ClinicalTrials.gov

See all 192 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo + Gemcitabine	202	322
Total, all-cause mortality	AMG 479 12 mg/kg Dose + Gemcitabine	210	318
Total, all-cause mortality	AMG 479 20 mg/kg + Gemcitabine	101	160
Total, other adverse events	Placebo + Gemcitabine	312	317
Total, other adverse events	AMG 479 12 mg/kg Dose + Gemcitabine	308	315
Total, other adverse events	AMG 479 20 mg/kg + Gemcitabine	159	160
Total, serious adverse events	Placebo + Gemcitabine	33	317
Total, serious adverse events	AMG 479 12 mg/kg Dose + Gemcitabine	30	315
Total, serious adverse events	AMG 479 20 mg/kg + Gemcitabine	18	160

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25609246	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01231347

GET https://conductscience.org/api/trials/v1/NCT01231347/events?page=2

API reference For AI assistants