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Trial record 30 of 533 for:    "Primary Peritoneal Carcinoma"

Study of Ramucirumab in Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00721162
Recruitment Status : Completed
First Posted : July 23, 2008
Results First Posted : June 18, 2014
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Intervention Biological: Ramucirumab
Enrollment 60
Recruitment Details  
Pre-assignment Details 73 participants signed informed consent.
Arm/Group Title Ramucirumab
Hide Arm/Group Description Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
Period Title: Overall Study
Started 60
Received Any Amount of Study Drug 60
Completed 60
Not Completed 0
Arm/Group Title Ramucirumab
Hide Arm/Group Description Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
All participants who received any amount of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
<=18 years
0
   0.0%
Between 18 and 65 years
36
  60.0%
>=65 years
24
  40.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
60
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Hispanic or Latino
1
   1.7%
Not Hispanic or Latino
59
  98.3%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants
Black or African American 5
White 52
Other 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants
United States 56
United Kingdom 4
1.Primary Outcome
Title Percentage of Participants With Progression-Free Survival at 6 Months (PFS-6)
Hide Description Data presented are the percentage of participants without progressive disease (PD) or death from any cause at 6 month after first dose. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion.
Time Frame First Dose to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received any amount of study drug.
Arm/Group Title Ramucirumab
Hide Arm/Group Description:
Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.0
(14.7 to 37.9)
2.Primary Outcome
Title Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) and Partial Response (PR)
Hide Description Objective response is confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression/recurrence or the start of new therapeutic anticancer treatment, whichever occurred first, divided by the total number of participants treated, then multiplied by 100.
Time Frame First dose to date of objective progressive disease /death or new anti-cancer therapy up to 34.6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received any amount of study drug.
Arm/Group Title Ramucirumab
Hide Arm/Group Description:
Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.0
(1.0 to 13.9)
3.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.
Time Frame First dose to measured progressive disease or death due to any cause up to 34.6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received any amount of study drug. The number of participants censored was 11.
Arm/Group Title Ramucirumab
Hide Arm/Group Description:
Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
Overall Number of Participants Analyzed 60
Median (95% Confidence Interval)
Unit of Measure: months
3.5
(2.3 to 5.3)
4.Secondary Outcome
Title Overall Survival at 1 Year (OS-1)
Hide Description Data presented are the percentage of participants surviving at least 12 months after first dose based on Kaplan Meier Method.
Time Frame First dose to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received any amount of study drug.
Arm/Group Title Ramucirumab
Hide Arm/Group Description:
Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48.0
(34.9 to 59.9)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, overall survival was censored on the last date the participant was known to be alive.
Time Frame First dose to death due to any cause up to 43.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received any amount of study drug. The number of participants censored was 12.
Arm/Group Title Ramucirumab
Hide Arm/Group Description:
Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
Overall Number of Participants Analyzed 60
Median (95% Confidence Interval)
Unit of Measure: months
11.1
(8.3 to 17.0)
6.Secondary Outcome
Title Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events
Hide Description Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.
Time Frame First dose to 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received any amount of study drug.
Arm/Group Title Ramucirumab
Hide Arm/Group Description:
Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
Related TEAE 56
Related SAE 10
Related Grade 3 or 4 TEAE 21
Related AE leading to discontinuation 4
Time Frame [Not Specified]
Adverse Event Reporting Description Deaths due to progressive disease are not considered adverse events (AE). Four deaths due to progressive disease were recorded by the investigator as serious AEs (SAE) and are captured in the SAE summary.
 
Arm/Group Title Ramucirumab
Hide Arm/Group Description Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
All-Cause Mortality
Ramucirumab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ramucirumab
Affected / at Risk (%) # Events
Total   22/60 (36.67%)    
Blood and lymphatic system disorders   
Thrombocytopenia  1  1/60 (1.67%)  1
Cardiac disorders   
Mitral valve incompetence  1  1/60 (1.67%)  1
Gastrointestinal disorders   
Ascites  1  1/60 (1.67%)  1
Gastritis  1  1/60 (1.67%)  1
Intestinal perforation  1  2/60 (3.33%)  3
Nausea  1  1/60 (1.67%)  1
Rectal haemorrhage  1  1/60 (1.67%)  1
Small intestinal obstruction  1  3/60 (5.00%)  5
Vomiting  1  1/60 (1.67%)  1
General disorders   
Abscess sterile  1  1/60 (1.67%)  1
Hernia obstructive  1  1/60 (1.67%)  1
Oedema peripheral  1  1/60 (1.67%)  1
Pyrexia  1  1/60 (1.67%)  2
Infections and infestations   
Peritonitis  1  1/60 (1.67%)  1
Postoperative wound infection  1  1/60 (1.67%)  1
Sepsis  1  1/60 (1.67%)  1
Injury, poisoning and procedural complications   
Expired drug administered  1  3/60 (5.00%)  3
Investigations   
Alanine aminotransferase increased  1  2/60 (3.33%)  2
Aspartate aminotransferase increased  1  1/60 (1.67%)  1
Hepatic enzyme increased  1  1/60 (1.67%)  1
Metabolism and nutrition disorders   
Hypercalcaemia  1  1/60 (1.67%)  1
Hypokalaemia  1  1/60 (1.67%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm progression  1  4/60 (6.67%)  5
Nervous system disorders   
Neuralgia  1  1/60 (1.67%)  2
Renal and urinary disorders   
Renal failure acute  1  1/60 (1.67%)  1
Reproductive system and breast disorders   
Female genital tract fistula  1  1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/60 (1.67%)  1
Pleural effusion  1  1/60 (1.67%)  1
Vascular disorders   
Deep vein thrombosis  1  1/60 (1.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ramucirumab
Affected / at Risk (%) # Events
Total   58/60 (96.67%)    
Blood and lymphatic system disorders   
Anaemia  1  11/60 (18.33%)  21
Thrombocytopenia  1  6/60 (10.00%)  20
Gastrointestinal disorders   
Abdominal discomfort  1  4/60 (6.67%)  4
Abdominal distension  1  7/60 (11.67%)  7
Abdominal pain  1  12/60 (20.00%)  14
Abdominal pain lower  1  5/60 (8.33%)  5
Constipation  1  13/60 (21.67%)  15
Diarrhoea  1  21/60 (35.00%)  41
Dyspepsia  1  6/60 (10.00%)  8
Gastrooesophageal reflux disease  1  4/60 (6.67%)  4
Gingival bleeding  1  6/60 (10.00%)  10
Nausea  1  26/60 (43.33%)  38
Stomatitis  1  11/60 (18.33%)  15
Vomiting  1  20/60 (33.33%)  31
General disorders   
Chills  1  5/60 (8.33%)  8
Fatigue  1  41/60 (68.33%)  72
Oedema peripheral  1  16/60 (26.67%)  23
Pyrexia  1  8/60 (13.33%)  11
Infections and infestations   
Nasopharyngitis  1  4/60 (6.67%)  6
Sinusitis  1  4/60 (6.67%)  4
Upper respiratory tract infection  1  4/60 (6.67%)  5
Urinary tract infection  1  13/60 (21.67%)  19
Investigations   
Alanine aminotransferase increased  1  4/60 (6.67%)  7
Aspartate aminotransferase increased  1  4/60 (6.67%)  11
Weight decreased  1  9/60 (15.00%)  13
Metabolism and nutrition disorders   
Decreased appetite  1  12/60 (20.00%)  16
Hyperglycaemia  1  7/60 (11.67%)  8
Hypoalbuminaemia  1  5/60 (8.33%)  5
Hypomagnesaemia  1  6/60 (10.00%)  6
Musculoskeletal and connective tissue disorders   
Arthralgia  1  12/60 (20.00%)  18
Back pain  1  9/60 (15.00%)  13
Joint swelling  1  6/60 (10.00%)  7
Muscular weakness  1  4/60 (6.67%)  4
Myalgia  1  7/60 (11.67%)  9
Pain in extremity  1  8/60 (13.33%)  11
Nervous system disorders   
Dizziness  1  7/60 (11.67%)  8
Dysgeusia  1  4/60 (6.67%)  4
Headache  1  43/60 (71.67%)  72
Psychiatric disorders   
Insomnia  1  7/60 (11.67%)  7
Renal and urinary disorders   
Proteinuria  1  8/60 (13.33%)  10
Reproductive system and breast disorders   
Vaginal haemorrhage  1  4/60 (6.67%)  6
Respiratory, thoracic and mediastinal disorders   
Cough  1  13/60 (21.67%)  14
Dysphonia  1  6/60 (10.00%)  7
Dyspnoea  1  12/60 (20.00%)  15
Epistaxis  1  8/60 (13.33%)  15
Oropharyngeal pain  1  5/60 (8.33%)  5
Skin and subcutaneous tissue disorders   
Alopecia  1  5/60 (8.33%)  5
Pruritus  1  4/60 (6.67%)  4
Vascular disorders   
Flushing  1  5/60 (8.33%)  6
Hypertension  1  16/60 (26.67%)  19
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00721162     History of Changes
Other Study ID Numbers: 13923
2007-006717-17 ( EudraCT Number )
CP12-0711 ( Other Identifier: ImClone Systems )
I4T-IE-JVBR ( Other Identifier: Eli Lilly and Company )
First Submitted: July 21, 2008
First Posted: July 23, 2008
Results First Submitted: May 16, 2014
Results First Posted: June 18, 2014
Last Update Posted: September 26, 2019