A Phase 2 interventional study of Gemcitabine and AMG 479 in Adenocarcinoma of the Pancreas, Locally Advanced and Unresectable, sponsored by NantBioScience, Inc.. Terminated at 35 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by NantBioScience, Inc. · Phase 2, Interventional, and Treatment
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.
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.
1,996 studies on the registry are indexed under Adenocarcinoma; 369 are open to participants now.
This study's enrollment of 10 is below the median of 44 across 1,549 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →NantBioScience, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle
Drug: Gemcitabine · Drug: Placebo
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.
Drug: Gemcitabine · Drug: AMG 479
Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
Also known as: 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.
Also known as: gemcitabine = Gemzar
Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
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.
Time frame: From randomization to the date of either disease progression or death, up to 181 days progression or death
Overall Survival
OS - time from study day 1 to death (by any cause)
Time frame: Up to 181 days
Number of Participants With Adverse Events
Measured via CTCAE v3.0
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
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
Time frame: 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
Time frame: Up to 181 days
Number of Participants With Anti-AMG 479 Antibodies
post-dose anti-AMG 479 antibody positive rate
Time frame: Up to 181 days
| Milestone | Placebo + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine |
|---|---|---|
| Started | 5 | 3 |
| Completed | 5 | 3 |
| Not completed | 0 | 0 |
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.
| Months | Placebo + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine |
|---|---|---|
| The Primary Endpoint is Progression-free Survival (PFS) as Defined as the Time From Randomization to Progression (Per RECIST v1.1) or Death. | NA (NA to NA) | NA (NA to NA) |
OS - time from study day 1 to death (by any cause)
| Months | Placebo + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine |
|---|---|---|
| Overall Survival | NA (NA to NA) | NA (NA to NA) |
Measured via CTCAE v3.0
| Participants | Placebo + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine |
|---|---|---|
| Number of Participants With Adverse Events | 5 | 3 |
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
| Participants | Placebo + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine |
|---|---|---|
| Progression Free Survival Rate at 3 months | 2 | 0 |
| Progression Free Survival Rate at 6 months | 2 | 0 |
| Overall Survival Rate at 3 months | 5 | 3 |
| Overall Survival Rate at 6 months | 4 | 3 |
| Objective Response Rate | NA | NA |
| Disease Control Rate | NA | NA |
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
| Months | Placebo + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine |
|---|---|---|
| Duration of Response | NA (NA to NA) | NA (NA to NA) |
post-dose anti-AMG 479 antibody positive rate
| Participants | Placebo + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine |
|---|---|---|
| Number of Participants With Anti-AMG 479 Antibodies | 0 | 0 |
Collected over For Adverse Events: from randomization through 30 (+3) days after the last administration of protocol specified therapy, up to 4 months. For Mortality: from randomization to the end of the study, up to 187 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo + Gemcitabine | 1/5 (20%) | 1/5 (20%) | 5/5 (100%) |
| AMG 479 20 mg/kg + Gemcitabine | 0/3 (0%) | 2/3 (66.7%) | 3/3 (100%) |
| Event | Placebo + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/5 | 1/3 |
| Oesophageal candidiasisInfections and infestations | 0/5 | 1/3 |
| Hepatic haematomaInjury, poisoning and procedural complications | 0/5 | 1/3 |
| General physical health deteriorationGeneral disorders | 1/5 | 0/3 |
| MalaiseGeneral disorders | 1/5 | 0/3 |
| Event | Placebo + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 2/5 | 3/3 |
| NeutropeniaBlood and lymphatic system disorders | 1/5 | 2/3 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/5 | 2/3 |
| FatigueGeneral disorders | 3/5 | 1/3 |
| Decreased appetiteMetabolism and nutrition disorders | 2/5 | 0/3 |
| DiarrhoeaGastrointestinal disorders | 2/5 | 0/3 |
| PyrexiaGeneral disorders | 2/5 | 0/3 |
| NauseaGastrointestinal disorders | 1/5 | 1/3 |
| Oedema peripheralGeneral disorders | 1/5 | 1/3 |
| Blood potassium decreasedInvestigations | 0/5 | 1/3 |
| Age, Continuous(years) | Placebo + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine | Total |
|---|---|---|---|
| Mean | 71.6 ± 11.8 | 63.0 ± 8.7 | 68.4 ± 11.0 |
| Sex: Female, Male(Participants) | Placebo + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine | Total |
|---|---|---|---|
| Female | 3 | 1 | 4 |
| Male | 2 | 2 | 4 |
| Race (NIH/OMB)(Participants) | Placebo + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 3 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Subjects with locally advanced unresectable adenocarcinoma of the pancreas(Participants) | Placebo + Gemcitabine | AMG 479 20 mg/kg + Gemcitabine | Total |
|---|---|---|---|
| Count of participants | 5 | 3 | 8 |
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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