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The purpose of this study is to obtain an estimate of the objective response rate (ORR) of AMG 479 in patients with recurrent platinum-sensitive ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma failing frontline chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 479 | Experimental | AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 479 | Biological | Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Investigator Assessment: % of Patients in the Group Who Achieve a Complete Response(CR) or Partial Response(PR) According to RECIST Criteria and GCIG CA125 Response Criteria. - Assessments of the Response by the Investigators | RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions & normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° & incomplete response/SD for nontarget les°. CR & PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:
| Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle |
| Objective Response Rate (ORR) Independent Radiology Committee % of Patients in the Group Who Achieve a Complete or Partial Response According to RECIST Criteria and GCIG CA 125 Response Criteria. | RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions & normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° & incomplete response/SD for nontarget les°. CR & PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:
|
| Measure | Description | Time Frame |
|---|---|---|
| Time To Progression (TTP) Investigator Assessment | Interval from the date of registration to the date of disease progression Investigator assessment As per RECIST (v1.0), disease progression represented an increase of at least 20% in the sum of the longest diameter (SLD) of target lesions, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gottfried E Konecny, MD | University of California, Los Angeles | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | United States | ||
| St Jude Heritage Healthcare |
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The study was conducted over a total of 35 sites in 7 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | AMG 479 | AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle |
| Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response |
| Clinical Benefit Rate (CBR) Investigator Assessmt % of Patients in the gp Who Achieve a Complete Response-CR,Partial Response-PR or Stable Disease-SD for 16wks From Registrat° Considering the Global Response Combining RECIST Criteria and CA125 Assessmts | RECIST(v1.0):
CA125 level:
Best overall resp of :
| At 16 weeks from registration |
| Overall Survival (OS) Investigator Assessment | Interval between the date of registration and the date of death | Day 1 of each cycle during study treatment + follow-up every 6 months for the first 3 years in the study or until death whichever occurs first |
| Time To Marker Progression (TTMP) Investigator Assessment - Interval Form the Date of Registration to the Date of Disease Progression as Per GCIG 2005 Definition of CA 125 Progression. | The GCIG criteria (November 2005) were used to define progressive disease, based on serum CA 125 levels, as follows:
| Day 1 of each cycle |
| Progression-free Survival (PFS) Investigator Assessment - Interval From Registration to Disease Progression or Death Due to Any Cause - According to RECIST and CA 125 | A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:
| Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response |
| Fullerton |
| California |
| 92835 |
| United States |
| Wilshire Oncology Medical Group Inc | La Verne | California | 91750 | United States |
| LAC/USC Medical Center | Los Angeles | California | 90033 | United States |
| University of Southern California/ Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| UCLA | Los Angeles | California | 90095-1678 | United States |
| North Valley Hematology/ Oncology Medical Group | Northridge | California | 91325 | United States |
| Ventura County Hematology Oncology Specialists | Oxnard | California | 93030 | United States |
| Central Hematology Oncology Medical Group Inc. | Pasadena | California | 91107 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States |
| St Joseph Mercy Health System | Ann Arbor | Michigan | 48106 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Comprehensive Cancer Centre of Nevada | Henderson | Nevada | 89052 | United States |
| Tom Baker Centre | Calgary | AB T2N 4N2 | Canada |
| Juravinski Cancer Center | Hamilton | ON L8S1B7 | Canada |
| CHUM Hôpital Notre Dama | Montreal | H2W 1Y5 | Canada |
| Jewish General Hospital | Montreal | H3G 1 E2 | Canada |
| Centre Hospitalier Départemental Les Oudairies | La Roche-sur-Yon | 85295 | France |
| Centre Léon Berard | Lyon | 69373 | France |
| Clinique Hartmann | Neuilly-sur-Seine | 92 | France |
| Institut Curie | Paris | 75005 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Charité Campus Benjamin Franklin | Berlin | 12200 | Germany |
| Universitatsklinikum Erlangen | Erlangen | 91054 | Germany |
| Universitatsklinikum Hamburg Eppendorf | Hamburg | 20246 | Germany |
| Cork University Hospital | Cork | Ireland |
| Mater Misericordiae University Hospital | Dublin | Ireland |
| Mater Private Hospital | Dublin | Ireland |
| St Jame's Hospital | Dublin | Ireland |
| Waterford Regional Hospital | Waterford | Ireland |
| Kaplan Medical Center | Rehovot | 76100 | Israel |
| Hospital Universitario de Tenerife | La Laguna (Santa Cruz de Tenerife) | 38320 | Spain |
| Hospital U 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Virgen Macarena de Sevilla | Seville | 341071 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AMG 479 | AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) | 6-point (0 to 5) ordinal scale to assess how the disease affects the daily living abilities of the patient and determine apporpriate treatment and prognosis | Number | participants |
| ||||||||||||||||||||||
| Time from initial diagnosis to registration | Mean | Standard Deviation | Months |
| ||||||||||||||||||||||
| Origin of tumor | Number | participants |
| |||||||||||||||||||||||
| Stage at First Diagnosis (International Federation of Gynecology and Obstetrics (FIGO) ) | 5-point ordinal scale to assess the extent of the disease (0 ->IV). Roman numeral staging from the less to the most advanced cancer. Individual stage (I to III) is broken down in substage: IA, IB, IC,... | Number | participants |
| ||||||||||||||||||||||
| Histopathologic Type | Number | participants |
| |||||||||||||||||||||||
| Histologic Grade (G) | Cancer cells compared with normal cells | Number | participants |
| ||||||||||||||||||||||
| CA 125 status | CA 125 level measurement from a blood sample | Number | participants |
| ||||||||||||||||||||||
| Number of prior therapies | Prior anti-tumor treatment characteristics | Number | participants |
|
| 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 | Objective Response Rate (ORR) Investigator Assessment: % of Patients in the Group Who Achieve a Complete Response(CR) or Partial Response(PR) According to RECIST Criteria and GCIG CA125 Response Criteria. - Assessments of the Response by the Investigators | RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions & normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° & incomplete response/SD for nontarget les°. CR & PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:
| Intent To Treat | Posted | Number | 95% Confidence Interval | percentage of patients | Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle |
|
|
| |||||||||||||||||||||||||
| Secondary | Time To Progression (TTP) Investigator Assessment | Interval from the date of registration to the date of disease progression Investigator assessment As per RECIST (v1.0), disease progression represented an increase of at least 20% in the sum of the longest diameter (SLD) of target lesions, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | Intent To Treat | Posted | Median | 95% Confidence Interval | months | Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response |
|
| ||||||||||||||||||||||||||
| Primary | Objective Response Rate (ORR) Independent Radiology Committee % of Patients in the Group Who Achieve a Complete or Partial Response According to RECIST Criteria and GCIG CA 125 Response Criteria. | RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions & normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° & incomplete response/SD for nontarget les°. CR & PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:
| Intent To Treat | Posted | Number | 95% Confidence Interval | percentage of patients | Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle |
| |||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) Investigator Assessmt % of Patients in the gp Who Achieve a Complete Response-CR,Partial Response-PR or Stable Disease-SD for 16wks From Registrat° Considering the Global Response Combining RECIST Criteria and CA125 Assessmts | RECIST(v1.0):
CA125 level:
Best overall resp of :
| Intent To Treat | Posted | Number | 95% Confidence Interval | percentage of patients | At 16 weeks from registration |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Investigator Assessment | Interval between the date of registration and the date of death | Intent To Treat | Posted | Median | 95% Confidence Interval | months | Day 1 of each cycle during study treatment + follow-up every 6 months for the first 3 years in the study or until death whichever occurs first |
|
| ||||||||||||||||||||||||||
| Secondary | Time To Marker Progression (TTMP) Investigator Assessment - Interval Form the Date of Registration to the Date of Disease Progression as Per GCIG 2005 Definition of CA 125 Progression. | The GCIG criteria (November 2005) were used to define progressive disease, based on serum CA 125 levels, as follows:
| Intent To Treat | Posted | Median | 95% Confidence Interval | months | Day 1 of each cycle |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Investigator Assessment - Interval From Registration to Disease Progression or Death Due to Any Cause - According to RECIST and CA 125 | A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:
| Intent To Treat | Posted | Median | 95% Confidence Interval | months | Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response |
|
Not provided
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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 | AMG 479 | AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study. AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle | 12 | 61 | 60 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Candida Infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthieu Rupin | Translational Research In Oncology (formerly CIRG) | +33 (1) 58 10 08 89 | matthieu.rupin@trioncology.org |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C545764 | ganitumab |
Not provided
Not provided
Not provided
| Germany |
|
| France |
|
| Ireland |
|
| Israel |
|
| Ovarian |
|
| Ovarian + Primary Peritoneal |
|
| Ovarian + Fallopian Tube |
|
| IIB |
|
| IIC |
|
| IIIA |
|
| IIIB |
|
| IIIC |
|
| IV |
|
| Endometroid |
|
| Clear cell |
|
| Mixed |
|
| Other |
|
| G3 (poorly differentiated) |
|
| Not done |
|
| With elevatCA125+target lesions+/-nontargetlesions |
|
| With CA125normal+target lesions+/-nontargetlesions |
|
| 3 therapies |
|
| 4 therapies |
|
| 5 therapies |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|