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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023978-39 | EudraCT Number |
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NCT01318642: Planned independent DMC Interim review: ended for futility
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From randomization to the date of either disease progression or death, up to 181 days progression or death |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | OS - time from study day 1 to death (by any cause) | Up to 181 days |
| Number of Participants With Adverse Events | Measured via CTCAE v3.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Francisco | California | 94115 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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The Safety Population was used for all summaries (including serious and non-serious adverse events). Only 8/10 subjects received at least 1 dose of protocol-specified treatment and therefore were included in the Safety Population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Gemcitabine | Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle. Placebo: Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AMG 479 | Drug | Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle. |
|
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| Placebo | Drug | Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle |
|
| 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 | 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 | Up to 181 days |
| Number of Participants With Anti-AMG 479 Antibodies | post-dose anti-AMG 479 antibody positive rate | Up to 181 days |
| Knoxville |
| Tennessee |
| 37909 |
| United States |
| Research Site | Salzburg | 5020 | Austria |
| Research Site | Steyr | 4400 | Austria |
| Research Site | Vienna | 1090 | Austria |
| Research Site | Edegem | 2650 | Belgium |
| Research Site | La Louvière | 7100 | Belgium |
| Research Site | Hradec Králové | 500 05 | Czechia |
| Research Site | Olomouc | 775 20 | Czechia |
| Research Site | Prague | 100 34 | Czechia |
| Research Site | Herlev | 2730 | Denmark |
| Research Site | Hamburg | 20249 | Germany |
| Research Site | Budapest | 1097 | Hungary |
| Research Site | Debrecen | 4012 | Hungary |
| Research Site | Miskolc | 3526 | Hungary |
| Research Site | Szolnok | 5004 | Hungary |
| Research Site | Lodz | 93-509 | Poland |
| Research Site | Poznan | 60-569 | Poland |
| Research Site | Warsaw | 02-097 | Poland |
| Research Site | Lisbon | 1649-035 | Portugal |
| Research Site | Porto | 4200-072 | Portugal |
| Research Site | Chelyabinsk | 454087 | Russia |
| Research Site | Moscow | 115478 | Russia |
| Research Site | Saint Petersburg | 197022 | Russia |
| Research Site | Samara | 443031 | Russia |
| Research Site | Seoul | 120-752 | South Korea |
| Research Site | Seoul | 135-710 | South Korea |
| Research Site | Seoul | 138-736 | South Korea |
| Research Site | Seoul | 152-703 | South Korea |
| Research Site | Barcelona | Cataluña | 08035 | Spain |
| Research Site | Madrid | 28034 | Spain |
| Research Site | Madrid | 28050 | Spain |
| Guys Hospital | London | SE1 9RT | United Kingdom |
| Research Site | London | W12 0HS | United Kingdom |
| Research Site | Preston | PR2 9HT | United Kingdom |
| FG001 |
| AMG 479 20 mg/kg + Gemcitabine |
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. Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle. AMG 479: Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle. |
| COMPLETED | Completed defined as receiving at least one dose of study drug. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Gemcitabine | Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle. Placebo: Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle |
| BG001 | AMG 479 20 mg/kg + Gemcitabine | 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. Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle. AMG 479: Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Subjects with locally advanced unresectable adenocarcinoma of the pancreas | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of either disease progression or death, up to 181 days progression or death |
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| Secondary | Overall Survival | OS - time from study day 1 to death (by any cause) | Posted | Median | 95% Confidence Interval | Months | Up to 181 days |
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| Secondary | Number of Participants With Adverse Events | Measured via CTCAE v3.0 | Posted | Count of Participants | Participants | Up to 4 months |
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| Secondary | 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 | Posted | Count of Participants | Participants | Up to 181 days |
| ||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Mean | Full Range | Months | Up to 181 days |
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| Secondary | Number of Participants With Anti-AMG 479 Antibodies | post-dose anti-AMG 479 antibody positive rate | Posted | Count of Participants | Participants | Up to 181 days |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo + Gemcitabine | Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle. Placebo: Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle | 1 | 5 | 1 | 5 | 5 | 5 |
| EG001 | AMG 479 20 mg/kg + Gemcitabine | 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. Gemcitabine: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle. AMG 479: Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle. | 0 | 3 | 2 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General physical health deterioration | General disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Oesophageal candidiasis | Infections and infestations | Systematic Assessment |
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| Hepatic haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Oedema peripheral | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Blood potassium decreased | Investigations | Systematic Assessment |
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| C-reactive protein increased | Investigations | Systematic Assessment |
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| Cachexia | Metabolism and nutrition disorders | Systematic Assessment |
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| Chest discomfort | General disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Confusional state | Psychiatric disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Systematic Assessment |
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| Febrile convulsion | Nervous system disorders | Systematic Assessment |
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| General physical health deterioration | General disorders | Systematic Assessment |
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| Hepatic haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| International normalised ratio increased | Investigations | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Mucosal inflammation | General disorders | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Oesophageal candidiasis | Infections and infestations | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
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The study was terminated early. Only the safety data is provided.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandeep Bobby Reddy, Chief Medical Officer | ImmunityBio | 866-572-6436 | Bobby.Reddy@Immunitybio.com |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C545764 | ganitumab |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units |
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