A Phase 3 interventional study of AMG 479 and Placebo in Adenocarcinoma of the Pancreas, Advanced Solid Tumors and Cancer, sponsored by NantCell, Inc.. Completed at 153 sites in 32 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by NantCell, Inc. · Phase 3, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 800 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →NantCell, Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Drug: Placebo · Drug: gemcitabine
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
Drug: AMG 479 · Drug: gemcitabine
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
Drug: AMG 479 · Drug: gemcitabine
AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
Placebo administered intravenously on days 1 and 15 of a 28 day cycle
AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
Also known as: Gemzar
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.
Time frame: From randomization up to 20 months
| Milestone | Placebo + Gemcitabine | AMG 479 12 mg/kg Dose + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine |
|---|---|---|---|
| Started | 322 | 318 | 160 |
| Completed | 90 | 78 | 43 |
| Not completed | 232 | 240 | 117 |
| Withdrew: Full consent withdrawn | 19 | 19 | 11 |
| Withdrew: Lost to follow-up | 4 | 2 | 2 |
| Withdrew: Death | 202 | 210 | 101 |
| Withdrew: Other event | 7 | 9 | 3 |
The primary endpoint of the study was OS, defined as the time from randomization to death.
| months | AMG 479 12 mg/kg Dose + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine | Placebo + Gemcitabine |
|---|---|---|---|
| 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 | 7.0 (6.2 to 8.5) | 7.1 (6.4 to 8.5) | 7.2 (6.3 to 8.2) |
Collected over Adverse events were collected from screening through 30 days after the last dose of last protocol specified therapy, up to 20 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo + Gemcitabine | 202/322 (62.7%) | 33/317 (10.4%) | 312/317 (98.4%) |
| AMG 479 12 mg/kg Dose + Gemcitabine | 210/318 (66%) | 30/315 (9.5%) | 308/315 (97.8%) |
| AMG 479 20 mg/kg + Gemcitabine | 101/160 (63.1%) | 18/160 (11.3%) | 159/160 (99.4%) |
| Event | Placebo + Gemcitabine | AMG 479 12 mg/kg Dose + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine |
|---|---|---|---|
| Pancreatic Carcinoma MetastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 5/317 | 3/315 | 4/160 |
| Pancreatic CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 5/317 | 7/315 | 1/160 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 0/317 | 4/315 | 3/160 |
| DeathGeneral disorders | 5/317 | 1/315 | 0/160 |
| CachexiaMetabolism and nutrition disorders | 0/317 | 4/315 | 0/160 |
| Adenocarcinoma PancreasNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/317 | 0/315 | 2/160 |
| General Physical Health DeteriorationGeneral disorders | 3/317 | 1/315 | 1/160 |
| Cardiac FailureCardiac disorders | 1/317 | 2/315 | 0/160 |
| Abdominal PainGastrointestinal disorders | 0/317 | 2/315 | 0/160 |
| Acute Myocardial InfarctionCardiac disorders | 2/317 | 0/315 | 0/160 |
| Event | Placebo + Gemcitabine | AMG 479 12 mg/kg Dose + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine |
|---|---|---|---|
| NauseaGastrointestinal disorders | 128/317 | 133/315 | 71/160 |
| ThrombocytopeniaBlood and lymphatic system disorders | 94/317 | 126/315 | 54/160 |
| FatigueGeneral disorders | 93/317 | 111/315 | 62/160 |
| NeutropeniaBlood and lymphatic system disorders | 109/317 | 117/315 | 52/160 |
| Decreased AppetiteMetabolism and nutrition disorders | 85/317 | 94/315 | 37/160 |
| VomitingGastrointestinal disorders | 72/317 | 89/315 | 46/160 |
| PyrexiaGeneral disorders | 69/317 | 67/315 | 43/160 |
| DiarrhoeaGastrointestinal disorders | 58/317 | 84/315 | 27/160 |
| HyperglycaemiaMetabolism and nutrition disorders | 31/317 | 63/315 | 42/160 |
| ConstipationGastrointestinal disorders | 62/317 | 82/315 | 29/160 |
| Age, Continuous(years) | Placebo + Gemcitabine | AMG 479 12 mg/kg Dose + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine | Total |
|---|---|---|---|---|
| Mean | 62.2 ± 9.6 | 62.1 ± 9.7 | 62.7 ± 10.1 | 62.3 ± 9.7 |
| Sex: Female, Male(Participants) | Placebo + Gemcitabine | AMG 479 12 mg/kg Dose + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine | Total |
|---|---|---|---|---|
| Female | 134 | 159 | 75 | 368 |
| Male | 188 | 159 | 85 | 432 |
| Race (NIH/OMB)(Participants) | Placebo + Gemcitabine | AMG 479 12 mg/kg Dose + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 34 | 19 | 14 | 67 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 4 | 0 | 7 |
| White | 253 | 258 | 129 | 640 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 32 | 37 | 17 | 86 |
| Region of Enrollment(Participants) | Placebo + Gemcitabine | AMG 479 12 mg/kg Dose + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine | Total |
|---|---|---|---|---|
| Europe | 216 | 219 | 112 | 547 |
| United States | 26 | 31 | 13 | 70 |
| Canada | 4 | 3 | 1 | 8 |
| Australia | 13 | 7 | 4 | 24 |
| Japan | 30 | 34 | 16 | 80 |
| North Asia | 28 | 16 | 13 | 57 |
| South America | 5 | 8 | 1 | 14 |
| Metastatic adenocarcinoma of the pancreas(Participants) | Placebo + Gemcitabine | AMG 479 12 mg/kg Dose + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine | Total |
|---|---|---|---|---|
| Count of participants | 322 | 318 | 160 | 800 |
Showing the first 100 of 153 sites across 32 countries.
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NantCell, Inc.