QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenoc... | NCT01231347

NCT01231347

Status Module

Name	Class
Takeda	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo + gemcitabine	Placebo Comparator	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
AMG 479 12 mg/kg dose + gemcitabine	Experimental	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
AMG 479 20 mg/kg + gemcitabine	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
AMG 479	Drug	AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle	AMG 479 12 mg/kg dose + gemcitabine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	From randomization up to 20 months

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
NantKWest Clinical Review Team	ImmunityBio, Inc.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Fullerton	California	92835	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25609246	Background	Fuchs CS, Azevedo S, Okusaka T, Van Laethem JL, Lipton LR, Riess H, Szczylik C, Moore MJ, Peeters M, Bodoky G, Ikeda M, Melichar B, Nemecek R, Ohkawa S, Swieboda-Sadlej A, Tjulandin SA, Van Cutsem E, Loberg R, Haddad V, Gansert JL, Bach BA, Carrato A. A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. Ann Oncol. 2015 May;26(5):921-927. doi: 10.1093/annonc/mdv027. Epub 2015 Jan 21.

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo + Gemcitabine	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 Placebo: Placebo administered intravenously on days 1 and 15 of a 28 day cycle gemcitabine: gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 20, 2010

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Placebo + Gemcitabine	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 Placebo: Placebo administered intravenously on days 1 and 15 of a 28 day cycle gemcitabine: gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
BG001	AMG 479 12 mg/kg Dose + 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 AMG 479: AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle gemcitabine: gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
BG002	AMG 479 20 mg/kg + 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 AMG 479: AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle gemcitabine: gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00062.2± 9.6 BG00162.1± 9.7 BG00262.7± 10.1 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000134 BG001159 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Europe

Title	Measurements
	BG000216 BG001219 BG002

Metastatic adenocarcinoma of the pancreas

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG000322 BG001318 BG002

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

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.

Full analysis set =all randomized subjects

Posted

Median

95% Confidence Interval

months

From randomization up to 20 months

ID	Title	Description
OG000	AMG 479 12 mg/kg Dose + 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 AMG 479: AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle gemcitabine: gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
OG001	AMG 479 20 mg/kg + 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 AMG 479: AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle gemcitabine: gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
OG002	Placebo + Gemcitabine	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 Placebo: Placebo administered intravenously on days 1 and 15 of a 28 day cycle gemcitabine: gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle

Units	Counts
Participants	OG000318 OG001160 OG002322

Title

Denominators

Categories

Title	Measurements
	OG0007.0(6.2 to 8.5) OG0017.1(6.4 to 8.5) OG0027.2(6.3 to 8.2)

Arm/Groups

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 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 Placebo: Placebo administered intravenously on days 1 and 15 of a 28 day cycle gemcitabine: gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle	202	322	33	317	312	317
EG001	AMG 479 12 mg/kg Dose + 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 AMG 479: AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle gemcitabine: gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle	210	318	30	315	308	315
EG002	AMG 479 20 mg/kg + 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 AMG 479: AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle gemcitabine: gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle	101	160	18	160	159	160

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected317 at risk EG0010 affected315 at risk EG0020 affected160 at risk
Thrombotic Thrombocytopenic Purpura	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected317 at risk EG0010 affected315 at risk EG0021 affected160 at risk
Acute Myocardial Infarction	Cardiac disorders	Systematic Assessment	EG0002 affected317 at risk EG0010 affected315 at risk EG0020 affected160 at risk
Cardiac Arrest	Cardiac disorders	Systematic Assessment	EG0000 affected317 at risk EG0010 affected315 at risk EG0021 affected160 at risk
Cardiac Failure	Cardiac disorders	Systematic Assessment	EG0001 affected317 at risk EG0012 affected315 at risk EG0020 affected160 at risk
Cardiogenic Shock	Cardiac disorders	Systematic Assessment	EG0000 affected317 at risk EG0010 affected315 at risk EG0021 affected160 at risk
Abdominal Pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected317 at risk EG0012 affected315 at risk EG0020 affected160 at risk
Ascites	Gastrointestinal disorders	Systematic Assessment	EG0000 affected317 at risk EG0011 affected315 at risk EG0020 affected160 at risk
Gastric Haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected317 at risk EG0010 affected315 at risk EG0020 affected160 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected317 at risk EG0011 affected315 at risk EG0020 affected160 at risk
Ileus Paralytic	Gastrointestinal disorders	Systematic Assessment	EG0001 affected317 at risk EG0010 affected315 at risk EG0020 affected160 at risk
Intestinal Obstruction	Gastrointestinal disorders	Systematic Assessment	EG0000 affected317 at risk EG0011 affected315 at risk EG0020 affected160 at risk
Subileus	Gastrointestinal disorders	Systematic Assessment	EG0000 affected317 at risk EG0010 affected315 at risk EG0021 affected160 at risk
Death	General disorders	Systematic Assessment	EG0005 affected317 at risk EG0011 affected315 at risk EG0020 affected160 at risk
General Physical Health Deterioration	General disorders	Systematic Assessment	EG0003 affected317 at risk EG0011 affected315 at risk EG0021 affected160 at risk
Performance Status Decreased	General disorders	Systematic Assessment	EG0000 affected317 at risk EG0011 affected315 at risk EG0020 affected160 at risk
Sudden Death	General disorders	Systematic Assessment	EG0002 affected317 at risk EG0010 affected315 at risk EG0020 affected160 at risk
Cholestasis	Hepatobiliary disorders	Systematic Assessment	EG0001 affected317 at risk EG0010 affected315 at risk EG0020 affected160 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	Systematic Assessment	EG0000 affected317 at risk EG0010 affected315 at risk EG0021 affected160 at risk
Jaundice	Hepatobiliary disorders	Systematic Assessment	EG0000 affected317 at risk EG0011 affected315 at risk EG0020 affected160 at risk
Peritonitis	Infections and infestations	Systematic Assessment	EG0000 affected317 at risk EG0011 affected315 at risk EG0020 affected160 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected317 at risk EG0010 affected315 at risk EG0021 affected160 at risk
Respiratory Tract Infection	Infections and infestations	Systematic Assessment	EG0000 affected317 at risk EG0011 affected315 at risk EG0020 affected160 at risk
Cachexia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected317 at risk EG0014 affected315 at risk EG0020 affected160 at risk
Adenocarcinoma Pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected317 at risk EG0010 affected315 at risk EG0022 affected160 at risk
Metastases To Liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected317 at risk EG0011 affected315 at risk EG0020 affected160 at risk
Pancreatic Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0005 affected317 at risk EG0017 affected315 at risk EG0021 affected160 at risk
Pancreatic Carcinoma Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0005 affected317 at risk EG0013 affected315 at risk EG0024 affected160 at risk
Pancreatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected317 at risk EG0010 affected315 at risk EG0020 affected160 at risk
Tumour Haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected317 at risk EG0010 affected315 at risk EG0020 affected160 at risk
Cerebrovascular Accident	Nervous system disorders	Systematic Assessment	EG0001 affected317 at risk EG0010 affected315 at risk EG0020 affected160 at risk
Coma Hepatic	Nervous system disorders	Systematic Assessment	EG0000 affected317 at risk EG0011 affected315 at risk EG0020 affected160 at risk
Renal Failure Acute	Renal and urinary disorders	Systematic Assessment	EG0001 affected317 at risk EG0010 affected315 at risk EG0020 affected160 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected317 at risk EG0011 affected315 at risk EG0020 affected160 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected317 at risk EG0014 affected315 at risk EG0023 affected160 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0000 affected317 at risk EG0010 affected315 at risk EG0021 affected160 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	Systematic Assessment	EG000128 affected317 at risk EG001133 affected315 at risk EG00271 affected160 at risk
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG000109 affected317 at risk EG001117 affected315 at risk EG00252 affected160 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG00094 affected317 at risk EG001126 affected315 at risk EG00254 affected160 at risk
Fatigue	General disorders	Systematic Assessment	EG00093 affected317 at risk EG001111 affected315 at risk EG00262 affected160 at risk
Decreased Appetite	Metabolism and nutrition disorders	Systematic Assessment	EG00085 affected317 at risk EG00194 affected315 at risk EG00237 affected160 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG00072 affected317 at risk EG00189 affected315 at risk EG00246 affected160 at risk
Pyrexia	General disorders	Systematic Assessment	EG00069 affected317 at risk EG00167 affected315 at risk EG00243 affected160 at risk
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG00076 affected317 at risk EG00164 affected315 at risk EG00236 affected160 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG00062 affected317 at risk EG00182 affected315 at risk EG00229 affected160 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG00058 affected317 at risk EG00184 affected315 at risk EG00227 affected160 at risk
Abdominal Pain	Gastrointestinal disorders	Systematic Assessment	EG00059 affected317 at risk EG00169 affected315 at risk EG00227 affected160 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG00031 affected317 at risk EG00163 affected315 at risk EG00242 affected160 at risk
Oedema Peripheral	Nervous system disorders	Systematic Assessment	EG00058 affected317 at risk EG00149 affected315 at risk EG00225 affected160 at risk
Alanine Aminotransferase Increased	Investigations	Systematic Assessment	EG00045 affected317 at risk EG00161 affected315 at risk EG00224 affected160 at risk
Aspartate Aminotransferase Increased	Investigations	Systematic Assessment	EG00040 affected317 at risk EG00156 affected315 at risk EG00221 affected160 at risk
Asthenia	General disorders	Systematic Assessment	EG00045 affected317 at risk EG00147 affected315 at risk EG00218 affected160 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00034 affected317 at risk EG00144 affected315 at risk EG00224 affected160 at risk
Leukopenia	Blood and lymphatic system disorders	Systematic Assessment	EG00032 affected317 at risk EG00147 affected315 at risk EG00215 affected160 at risk
Weight Decreased	Investigations	Systematic Assessment	EG00029 affected317 at risk EG00127 affected315 at risk EG00223 affected160 at risk
Haemoglobin Decreased	Investigations	Systematic Assessment	EG00022 affected317 at risk EG00138 affected315 at risk EG0029 affected160 at risk
Platelet Count Decreased	Investigations	Systematic Assessment	EG00017 affected317 at risk EG00131 affected315 at risk EG00221 affected160 at risk
Abdominal Pain Upper	General disorders	Systematic Assessment	EG00017 affected317 at risk EG00131 affected315 at risk EG00221 affected160 at risk
Back Pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00026 affected317 at risk EG00122 affected315 at risk EG00215 affected160 at risk
Blood Alkaline Phosphatase Increased	Investigations	Systematic Assessment	EG00019 affected317 at risk EG00131 affected315 at risk EG00210 affected160 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00021 affected317 at risk EG00122 affected315 at risk EG00212 affected160 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG00025 affected317 at risk EG00120 affected315 at risk EG00210 affected160 at risk
Dysgeusia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00013 affected317 at risk EG00123 affected315 at risk EG00213 affected160 at risk
Hyperbilirubinaemia	Blood and lymphatic system disorders	Systematic Assessment	EG00011 affected317 at risk EG00124 affected315 at risk EG00213 affected160 at risk

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D006932	Hyperbilirubinemia
D012877	Skin Manifestations
D012816	Signs and Symptoms

ID	Term
D009369	Neoplasms
D010190	Pancreatic Neoplasms
D009362	Neoplasm Metastasis
D004701	Endocrine Gland Neoplasms
D007565	Jaundice

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring