A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma (RAINBOW)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01170663
First received: July 21, 2010
Last updated: August 29, 2014
Last verified: August 2014
Results First Received: July 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Gastric Cancer
Interventions: Biological: Ramucirumab (IMC-1211B) DP
Drug: Placebo
Drug: Paclitaxel

  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
One (1) participant was randomized to the placebo/paclitaxel group but received ramucirumab (IMC-1121B) in error. For the Intent-to-Treat (ITT) population this participant was included in the placebo/paclitaxel treatment group and for the Safety population (Pop) this participant was included in ramucirumab (IMC-1121B)/paclitaxel treatment group.

Reporting Groups
  Description
Ramucirumab (IMC-1211B) Plus Paclitaxel 8 milligrams/kilogram (mg/kg) of ramucirumab (IMC-1121B) was administered by intravenous (IV) infusion on Days 1 and 15 in combination with 80 milligrams/square meter (mg/m²) paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Placebo Plus Paclitaxel Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.

Participant Flow:   Overall Study
    Ramucirumab (IMC-1211B) Plus Paclitaxel     Placebo Plus Paclitaxel  
STARTED     330     335  
Received Any Treatment (Safety Pop)     327     329  
COMPLETED     306 [1]   308 [1]
NOT COMPLETED     24     27  
Alive on treatment at data cut-off date                 13                 7  
Lost to Follow-up                 3                 9  
Withdrawal of consent without follow-up                 8                 11  
[1] Participants who died due to any cause or alive at study end but off study drug considered complete.



  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-1211B) Plus Paclitaxel 8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Placebo Plus Paclitaxel Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
Total Total of all reporting groups

Baseline Measures
    Ramucirumab (IMC-1211B) Plus Paclitaxel     Placebo Plus Paclitaxel     Total  
Number of Participants  
[units: participants]
  330     335     665  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     204     212     416  
>=65 years     126     123     249  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 25 to 83 )  
  61  
  ( 24 to 84 )  
  61  
  ( 24 to 84 )  
Gender  
[units: participants]
     
Female     101     92     193  
Male     229     243     472  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     31     26     57  
Not Hispanic or Latino     299     309     608  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     110     121     231  
Black or African American     6     6     12  
White     208     199     407  
More than one race     0     1     1  
Other     6     7     13  
Region of Enrollment  
[units: participants]
     
Portugal     2     0     2  
United States     12     12     24  
Estonia     5     5     10  
Taiwan     14     16     30  
Spain     8     13     21  
Russian Federation     8     13     21  
Chile     1     3     4  
Italy     13     15     28  
France     20     14     34  
Australia     18     23     41  
Korea, Republic of     23     22     45  
Lithuania     6     6     12  
Austria     4     2     6  
United Kingdom     6     9     15  
Hungary     20     9     29  
Mexico     2     2     4  
Argentina     1     0     1  
Poland     15     18     33  
Brazil     19     16     35  
Belgium     12     14     26  
Singapore     2     3     5  
Romania     7     7     14  
Bulgaria     7     5     12  
Germany     20     20     40  
Japan     68     72     140  
Hong Kong     2     1     3  
Israel     15     15     30  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival Time (OS)   [ Time Frame: Randomization up to 27.5 months ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Randomization up to 22.2 months ]

3.  Secondary:   Time to Progressive Disease (TTP)   [ Time Frame: Baseline up to 22.2 months ]

4.  Secondary:   Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD   [ Time Frame: Randomization up to 22.2 months ]

5.  Secondary:   Percentage of Participants With CR or PR [Objective Response Rate (ORR)]   [ Time Frame: Randomization up to 22.2 months ]

6.  Secondary:   Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity)   [ Time Frame: Prior to and after ramucirumab (IMC-1121B) infusion: Day 1 Cycles 1, 2 and 3 (28-day cycles) Doses 1, 4, 7 and 30-37 days after last dose of study therapy up to 103 weeks ]

7.  Secondary:   Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion   [ Time Frame: Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles) ]

8.  Secondary:   Cmax After 4th Ramucirumab (IMC-1211B) Infusion   [ Time Frame: Cycle 2, Day 15 1 hour post end of infusion (28-day cycles) ]

9.  Secondary:   Cmax After 7th Ramucirumab (IMC-1211B) Infusion   [ Time Frame: Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles) ]

10.  Secondary:   Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion   [ Time Frame: Cycle 1, Day 1 predose (28-day cycles) ]

11.  Secondary:   Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion   [ Time Frame: Cycle 2, Day 15 (28-day cycle) ]

12.  Secondary:   Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion   [ Time Frame: Cycle 4, Day 1 (28-day cycles) ]

13.  Secondary:   Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status   [ Time Frame: Baseline, end of therapy (up to 103 weeks) ]

14.  Secondary:   Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score   [ Time Frame: Baseline, end of therapy (up to 103 weeks) ]

15.  Other Pre-specified:   Number of Participants With Serious and Other Non-serious Adverse Events (AE) and Who Died   [ Time Frame: Baseline up to 103 weeks and within 30 days of last dose of study drug ]


  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
One (1) participant was randomized to the placebo/paclitaxel group but received ramucirumab in error. For ITT population this participant was included in placebo/paclitaxel group and for the Safety population included in the ramucirumab group.


  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: NCT01170663     History of Changes
Other Study ID Numbers: 13894, I4T-IE-JVBE, CP12-0922, 2010-020426-18
Study First Received: July 21, 2010
Results First Received: July 1, 2014
Last Updated: August 29, 2014
Health Authority: Argentina: Ministry of Health
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: Ministry of Health
Chile: Ministry of Health
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Ministry of Health
Poland: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration