A Study of Paclitaxel With or Without Ramucirumab 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 14, 2013
Last verified: August 2013

July 21, 2010
August 14, 2013
December 2010
July 2013   (final data collection date for primary outcome measure)
Overall survival time (OS) [ Time Frame: Approximately 32 months ] [ Designated as safety issue: No ]
Overall survival time is measured as randomization to date of death from any cause.
Overall survival time (OS) [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]
Randomization to date of death from any cause
Complete list of historical versions of study NCT01170663 on ClinicalTrials.gov Archive Site
  • Progression-free survival (PFS) [ Time Frame: Approximately 32 months ] [ Designated as safety issue: No ]
    PFS is measured from randomization to the first radiographically documented progressive disease (PD) or death.
  • Time to progressive disease (TTP) [ Time Frame: Approximately 32 months ] [ Designated as safety issue: No ]
    TTP is the time from randomization to the first radiographically documented progressive disease.
  • Best overall response (BOR) [ Time Frame: Approximately 32 months ] [ Designated as safety issue: No ]
    Number of participants whose best response is categorized as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) (ver 1.1) guidelines.
  • Objective response (ORR) [ Time Frame: Approximately 32 months ] [ Designated as safety issue: No ]
    Proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR) compared to the total number of participants. Best response is categorized using the Response Evaluation Criteria In Solid Tumors (RECIST) (ver 1.1) guidelines.
  • Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity) [ Time Frame: 32 months ] [ Designated as safety issue: No ]
    This assessment will only be done at specific time points i.e. Prior to (within Pretreatment period) and after first ramucirumab infusion, prior to and after fourth ramucirumab infusion (approx. week 6 after first dose), prior to and after seventh ramucirumab infusion (approx. week 12 after first dose) and 30-37 days after last dose of study therapy.
  • Maximum concentration (Cmax) after first ramucirumab infusion [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Maximum concentration (Cmax) is the maximum peak concentration measured in blood serum after first ramucirumab infusion.
  • Maximum concentration (Cmax) after 4th ramucirumab infusion [ Time Frame: Approximately week 6 (Cycle 2, Day 15) ] [ Designated as safety issue: No ]
    Maximum concentration (Cmax) is the maximum peak concentration measured in blood serum after 4th ramucirumab infusion.
  • Maximum concentration (Cmax) after 7th ramucirumab infusion [ Time Frame: Approximately week 12 (Cycle 4, Day 1) ] [ Designated as safety issue: No ]
    Maximum concentration (Cmax) is the maximum peak concentration measured in blood serum after 7th ramucirumab infusion.
  • Minimum concentration (Cmin) prior to first ramucirumab infusion [ Time Frame: within the pretreatment period until Day 1 ] [ Designated as safety issue: No ]
    Minimum concentration (Cmin) is the minimum trough concentration measured in blood serum prior to first ramucirumab infusion.
  • Minimum concentration (Cmin) prior to 4th ramucirumab infusion [ Time Frame: Approximately week 6 (Cycle 2, Day 15) ] [ Designated as safety issue: No ]
    Minimum concentration (Cmin) is the minimum trough concentration measured in blood serum prior to 4th ramucirumab infusion.
  • Minimum concentration (Cmin) prior to 7th ramucirumab infusion [ Time Frame: Approximately week 12 (Cycle 4, Day 1) ] [ Designated as safety issue: No ]
    Minimum concentration (Cmin) is the minimum trough concentration measured in blood serum prior to 7th ramucirumab infusion.
  • Change in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 [ Time Frame: 32 months ] [ Designated as safety issue: No ]
    Change from baseline in the patient reported outcomes measured at the end of therapy visit
  • Change in EuroQol EQ-5D [ Time Frame: 32 months ] [ Designated as safety issue: No ]
    Change from baseline to the end of therapy visit
  • Progression-free survival (PFS) [ Time Frame: 32 months ] [ Designated as safety issue: No ]
    Radiographic assessment: Time from randomization to the first radiographic documented PD or death
  • Time to progressive disease (TTP) [ Time Frame: 32 months ] [ Designated as safety issue: No ]
    Time from Pretreatment, every 6 weeks after first infusion until first radiographic progressive disease (PD)
  • Best overall response (BOR) [ Time Frame: 32 months ] [ Designated as safety issue: No ]
    Pretreatment, every 6 weeks after first infusion until progressive disease (PD) will be determined using the RECIST (version1.1) guidelines
  • Objective response rate (ORR) [ Time Frame: 32 months ] [ Designated as safety issue: No ]
    Pretreatment, every 6 weeks after first infusion until progressive disease (PD); calculated as the number of patients who achieved a BOR of complete response (CR) or partial response (PR), divided by the total number of patients randomized
  • Serum Anti-Ramucirumab Antibody Assessment [ Time Frame: 32 months ] [ Designated as safety issue: No ]
    Prior to (within Pretreatment period) 1st ramucirumab infusion, prior to 4th ramucirumab infusion ( ~ week 6 after 1st dose), prior to 7th ramucirumab infusion (~ week 12 after first dose) and 30 - 37 days after last dose of therapy
  • Maximum concentration (Cmax) (ramucirumab + placebo) [ Time Frame: Cycle 1, Day 1 ] [ Designated as safety issue: No ]
    Prior to (within Pretreatment period) 1st ramucirumab infusion, prior to 4th ramucirumab infusion ( ~ week 6 after 1st dose), prior to 7th ramucirumab infusion (~ week 12 after first dose) and 30 - 37 days after last dose of therapy
  • Maximum concentration (Cmax) (ramucirumab + placebo) [ Time Frame: Cycle 2, Day 1 ] [ Designated as safety issue: No ]
    Prior to (within Pretreatment period) 1st ramucirumab infusion, prior to 4th ramucirumab infusion ( ~ week 6 after 1st dose), prior to 7th ramucirumab infusion (~ week 12 after first dose) and 30 - 37 days after last dose of therapy
  • Maximum concentration (Cmax) (ramucirumab + placebo) [ Time Frame: Cycle 4, Day 1 ] [ Designated as safety issue: No ]
    Prior to (within Pretreatment period) 1st ramucirumab infusion, prior to 4th ramucirumab infusion ( ~ week 6 after 1st dose), prior to 7th ramucirumab infusion (~ week 12 after first dose) and 30 - 37 days after last dose of therapy
  • Maximum concentration (Cmin) (ramucirumab + placebo) [ Time Frame: Cycle 1, Day 1 ] [ Designated as safety issue: No ]
    Prior to (within Pretreatment period) 1st ramucirumab infusion, prior to 4th ramucirumab infusion ( ~ week 6 after 1st dose), prior to 7th ramucirumab infusion (~ week 12 after first dose) and 30 - 37 days after last dose of therapy
  • Maximum concentration (Cmin) (ramucirumab + placebo) [ Time Frame: Cycle 2, Day 1 ] [ Designated as safety issue: No ]
    Prior to (within Pretreatment period) 1st ramucirumab infusion, prior to 4th ramucirumab infusion ( ~ week 6 after 1st dose), prior to 7th ramucirumab infusion (~ week 12 after first dose) and 30 - 37 days after last dose of therapy
  • Maximum concentration (Cmin) (ramucirumab + placebo) [ Time Frame: Cycle 4, Day 1 ] [ Designated as safety issue: No ]
    Prior to (within Pretreatment period) 1st ramucirumab infusion, prior to 4th ramucirumab infusion ( ~ week 6 after 1st dose), prior to 7th ramucirumab infusion (~ week 12 after first dose) and 30 - 37 days after last dose of therapy
Not Provided
Not Provided
 
A Study of Paclitaxel With or Without Ramucirumab in Metastatic Gastric Adenocarcinoma
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine

This is a phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab drug product (DP) compared to paclitaxel plus placebo.

The aim of this study is to determine if paclitaxel given together with ramucirumab as second line therapy will prolong overall survival compared to paclitaxel alone.

Approximately 663 patients (at least 18 years) in approximately 200 study centers and in approximately 30 countries will be randomized with histologically or cytologically confirmed metastatic gastric or gastroesophageal junction adenocarcinoma. Patients must have received at least one cycle of first line therapy with any platinum/fluoropyrimidine doublet with or without anthracycline (epirubicin or doxorubicin) and must have discontinued this therapy prior to study entry due to disease progression.

Upon registration and completion of screening procedure and reviewing the Inclusion and Exclusion Criteria eligible patients will be randomized to receive either paclitaxel plus ramucirumab or paclitaxel plus placebo.

Ramucirumab DP/placebo will be administered i.v. on days 1 and 15 , paclitaxel will be administered i.v. on days 1, 8 and 15 of a 4 weekly cycle.

Patients will be continuously treated and monitored until radiographic or symptomatic progression of disease, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Gastric Cancer
  • Biological: Ramucirumab DP
    8 mg/kg I.V. infusion on Days 1 and 15 of every 4-week cycle
    Other Names:
    • LY3009806
    • IMC-1211B
  • Drug: Placebo
    Ramucirumab placebo I.V. infusion on Days 1 and 15 of every 4-week cycle
  • Drug: Paclitaxel
    Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle
  • Experimental: Ramucirumab DP and Paclitaxel
    Ramucirumab DP and Paclitaxel
    Interventions:
    • Biological: Ramucirumab DP
    • Drug: Paclitaxel
  • Placebo Comparator: Placebo and Paclitaxel
    Placebo and Paclitaxel
    Interventions:
    • Drug: Placebo
    • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
665
September 2014
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent
  • histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
  • Metastatic disease or locally advanced, unresectable disease
  • Disease progression during or within 4 months after the last dose of the first-line therapy (platinum/fluoropyrimidine doublet with or without anthracycline)
  • Organs are functioning well (liver, kidney, blood)
  • Good performance status (ECOG 0 to 1)

Exclusion Criteria:

  • First line chemotherapy for metastatic gastric cancer other than platinum/fluoropyrimidine doublet with or without anthracycline
  • Previous systemic therapy with other anti-angiogenic drugs
  • Uncontrolled high blood pressure
  • Symptomatic or poorly controlled heart disease or had a heart attack or stroke within the last 6 month
  • Evidence of CNS metastasis at baseline
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Chile,   Estonia,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Lithuania,   Mexico,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Spain,   Taiwan,   United Kingdom
 
NCT01170663
13894, I4T-IE-JVBE, CP12-0922, 2010-020426-18
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP