A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib (REACH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01140347
First received: June 2, 2010
Last updated: March 30, 2015
Last verified: March 2015
Results First Received: March 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hepatocellular Carcinoma
Interventions: Biological: Placebo
Biological: Ramucirumab DP (IMC-1121B)
Other: BSC

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who died due to any cause or were alive and on study at conclusion but off treatment were considered to have completed the study.

Reporting Groups
  Description
Ramucirumab (IMC-1121B) + BSC

Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) intravenous (IV) infusion every 2 weeks.

Best supportive care (BSC): Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.

Placebo + BSC Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.

Participant Flow:   Overall Study
    Ramucirumab (IMC-1121B) + BSC     Placebo + BSC  
STARTED     283     282  
Received at Least 1 Dose of Study Drug     277     276  
COMPLETED     260     263  
NOT COMPLETED     23     19  
Lost to Follow-up                 5                 6  
Withdrawal by Subject                 13                 8  
On study treatment at study conclusion                 5                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants.

Reporting Groups
  Description
Ramucirumab (IMC-1121B) + BSC Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
Placebo + BSC Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
Total Total of all reporting groups

Baseline Measures
    Ramucirumab (IMC-1121B) + BSC     Placebo + BSC     Total  
Number of Participants  
[units: participants]
  283     282     565  
Age  
[units: years]
Mean (Standard Deviation)
  62.9  (11.56)     62.5  (11.10)     62.7  (11.33)  
Age, Customized  
[units: participants]
     
<65 years     150     162     312  
≥65 years     133     120     253  
Gender  
[units: participants]
     
Female     47     40     87  
Male     236     242     478  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     23     20     43  
Not Hispanic or Latino     253     260     513  
Unknown or Not Reported     7     2     9  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     131     135     266  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     3     8  
White     139     137     276  
More than one race     0     0     0  
Unknown or Not Reported     8     7     15  
Region of Enrollment  
[units: participants]
     
United States     17     20     37  
Portugal     0     2     2  
Philippines     1     0     1  
Taiwan     33     25     58  
Hong Kong     14     10     24  
Spain     9     12     21  
Thailand     5     1     6  
Israel     1     1     2  
Switzerland     1     1     2  
Italy     33     18     51  
France     32     27     59  
Australia     3     8     11  
Netherlands     2     1     3  
Korea, Republic of     28     42     70  
Finland     0     3     3  
Austria     4     4     8  
Czech Republic     11     9     20  
Hungary     1     0     1  
Canada     0     1     1  
Belgium     3     5     8  
Brazil     15     12     27  
Romania     3     4     7  
Bulgaria     2     4     6  
Germany     19     21     40  
Norway     1     1     2  
Japan     45     48     93  
Sweden     0     2     2  



  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: Randomization to death from any cause (up to 37 months) ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Randomization to PD (up to 36 months) ]

3.  Secondary:   Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]   [ Time Frame: Baseline to the date of first evidence of confirmed CR or PR (up to 37 months) ]

4.  Secondary:   Time to Radiographic Progression (TTP)   [ Time Frame: Randomization to PD (up to 36 months) ]

5.  Secondary:   Change From Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)   [ Time Frame: Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), and end of treatment (up to 34 months) ]

6.  Secondary:   Change From Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score   [ Time Frame: Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), end of treatment (up to 34 months) ]

7.  Secondary:   Number of Participants With Adverse Events (AEs) and the Number of Participants Who Died   [ Time Frame: Baseline to study completion (up to 37 months) ]

8.  Secondary:   Maximum Concentration (Cmax) of Ramucirumab, Cycle 1   [ Time Frame: 1 hour following the completion of Cycle 1 (14-day cycle) infusion ]

9.  Secondary:   Cmax of Ramucirumab, Cycle 4   [ Time Frame: 1 hour following completion of Cycle 4 (14-day cycles) infusion ]

10.  Secondary:   Cmax of Ramucirumab, Cycle 7   [ Time Frame: 1 hour following completion of Cycle 7 (14-day cycles) infusion ]

11.  Secondary:   Number of Participants With Treatment Emergent Positive Anti-Ramucirumab Response [Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)]   [ Time Frame: Prior to treatment and 1 hour post end of infusion for Cycles 1, 4 and 7 (14-day cycles) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01140347     History of Changes
Other Study ID Numbers: 13895, CP12-0919, I4T-IE-JVBF, 2010-019318-26
Study First Received: June 2, 2010
Results First Received: March 13, 2015
Last Updated: March 30, 2015
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Finland: Finnish Medicines Agency
Germany: Paul-Ehrlich-Institut
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Indonesia: National Agency of Drug and Food Control
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Malaysia: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Philippines: Bureau of Food and Drugs
Poland: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Singapore: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
South Korea: Korea Food and Drug Administration (KFDA)
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan: Department of Health
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency