NCT02539225|CompletedPhase 2Results

A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of S-1 and Oxaliplatin With or Without Ramucirumab as First-line Therapy Followed by Paclitaxel With Ramucirumab as Second-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Eli Lilly and Company ClinicalTrials.gov

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2 other identifiers

15461I4T-JE-JVCW

Study Type

interventional

Target

191

Locations

3 countries

Sites

Timeline

RegisteredSep 2015

StartedOct 2015

CompletionMar 2021

Brief Summary

The main purpose of this study is to evaluate the effectiveness of S-1 and oxaliplatin with or without ramucirumab as first line therapy in participants with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

191

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2015

Longer than P75 for phase_2

Geographic Reach

3 countries

34 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.4 years study duration

First Submitted

Initial submission to the registry

August 31, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed

1 month until next milestone

Study Start

First participant enrolled

October 5, 2015

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2017

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

February 15, 2019

Completed

2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2021

Completed

Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2.1 years

First QC Date

August 31, 2015

Results QC Date

August 23, 2018

Last Update Submit

February 23, 2022

Conditions

Metastatic Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 millimeter (mm) or the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up were censored at the day of their last adequate tumor assessment.
Randomization to Radiographic Documentation of Progression or Death Due to Any Cause (Up to 25 Months)

Secondary Outcomes (7)

Progression-free Survival to the Second Disease Progression (PFS 2)
Randomization to Second Radiographic Documentation of Progression or Death Due to Any Cause (Up to 31 Months)
Overall Survival (OS)
Randomization to Death Due to Any Cause (Up to 31 Months)
Percentage of Participants With Objective Response Rate (ORR)
Randomization to Disease Progression (Up to 25 Months)
Disease Control Rate (DCR)
Randomization to Disease Progression (Up to 25 Months)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A
Cycle 1 Day 1 & 8 Predose, Cycle 2 Day 1 Predose, Cycle 3 Day 1 Predose, Cycle 5 Day 1 Predose, Cycle 9 Day 1 Predose
+2 more secondary outcomes

Study Arms (2)

S-1/Oxaliplatin + Ramucirumab

EXPERIMENTAL

(Part A) Ramucirumab intravenously (IV) on day 1 and day 8 along with S-1 by mouth (PO) on days 1-14 and oxaliplatin IV on day 1 of each 21 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met then move to Part B. (Part B) Ramucirumab IV on day 1 and day 15 along with paclitaxel IV on day 1, 8, and 15 of each 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.

Drug: RamucirumabDrug: S-1Drug: OxaliplatinDrug: Paclitaxel

S-1/Oxaliplatin + Placebo

ACTIVE COMPARATOR

(Part A) Placebo IV on day 1 and day 8 along with S-1 PO on days 1-14 and oxaliplatin IV on day 1 of each 21 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met then move to Part B. (Part B) Ramucirumab IV on day 1 and day 15 along with paclitaxel IV on day 1, 8, and 15 of each 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.

Drug: RamucirumabDrug: PlaceboDrug: S-1Drug: OxaliplatinDrug: Paclitaxel

Interventions

RamucirumabDRUG

Administered IV

Also known as: LY3009806, IMC-1121B, Cyramza

S-1/Oxaliplatin + PlaceboS-1/Oxaliplatin + Ramucirumab

PlaceboDRUG

Administered IV

S-1/Oxaliplatin + Placebo

S-1DRUG

Administered PO

S-1/Oxaliplatin + PlaceboS-1/Oxaliplatin + Ramucirumab

OxaliplatinDRUG

Administered IV

S-1/Oxaliplatin + PlaceboS-1/Oxaliplatin + Ramucirumab

PaclitaxelDRUG

Administered IV

S-1/Oxaliplatin + PlaceboS-1/Oxaliplatin + Ramucirumab

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Have a histopathologically or cytologically confirmed diagnosis of metastatic gastric or GEJ adenocarcinoma. Participants with esophageal cancer are not eligible.
Have not received any prior first-line systemic therapy for gastric or GEJ adenocarcinoma (prior adjuvant or neoadjuvant therapy is permitted). Participants whose disease has progressed after \>24 weeks following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
Have measurable or nonmeasurable but evaluable disease determined using guidelines in Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1).
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale at baseline.
Have adequate organ function.
Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator.
Eligible participants of reproductive potential (both sexes) must agree to use contraception (hormonal or barrier methods) during the study period and at least 6 months after the last dose of study treatment or longer if required per local regulations.
Are willing to provide a blood sample for research purposes. Submission of a blood sample is mandatory for participation in this study unless restricted by local regulations or ethical review boards (ERBs); submission of a tumor tissue sample is optional.

You may not qualify if:

Participants with human epidermal growth factor receptor 2 (HER2)-positive status as determined per local standards. Participants with a negative test or having an indeterminate result due to any reason are eligible, provided these participants are not eligible for treatment directed against tumors which overexpress HER2.
Have radiation therapy within 14 days prior to randomization. Any lesion requiring palliative radiation or which has been previously irradiated cannot be considered for response assessment.
Have documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
Have undergone major surgery within 28 days prior to randomization.
Are currently enrolled in, or discontinued study drug within the last 28 days from, a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study drug used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Participants participating in surveys or observational studies are eligible to participate in this study.
Are pregnant or breast feeding. Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to first dose of study treatment.
Have any prior malignancies.
Have any condition (eg, psychological, geographical, or medical) that does not permit compliance with the study and follow-up procedures or suggest that the participant is, in the investigator's opinion, not an appropriate candidate for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (34)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Akashi, 673-8558, Japan

Location

Bunkyō City, 113-8677, Japan

Location

Chiba, 260-8717, Japan

Location

Gifu, 501-1194, Japan

Location

Kochi, 781-8555, Japan

Location

Kōtoku, 135-8550, Japan

Location

Kōtoku, 135-8577, Japan

Location

Kumamoto, 860-8556, Japan

Location

Nagoya, 464-8681, Japan

Location

Nagoya, 466-8560, Japan

Location

Osaka, 534-0021, Japan

Location

Osaka, 541-8567, Japan

Location

Osaka, 558-8558, Japan

Location

Sagamihara, 252-0375, Japan

Location

Sakai, 593-8304, Japan

Location

Sapporo, 060-8648, Japan

Location

Shinjuku-Ku, 160-8582, Japan

Location

Suita-shi, 565-0871, Japan

Location

Takatsuki, 569-8686, Japan

Location

Toyonaka, 560-8565, Japan

Location

Utsunomiya, 320-0834, Japan

Location

Yokohama, 224-8503, Japan

Location

Yokohama, 241-8515, Japan

Location

Seoul, 03080, South Korea

Location

Seoul, 03722, South Korea

Location

Seoul, 05505, South Korea

Location

Seoul, 06273, South Korea

Location

Seoul, 06351, South Korea

Location

Ulsan, 44033, South Korea

Location

Kuei Shan Hsiang, 33305, Taiwan

Location

Taichung, 40447, Taiwan

Location

Tainan, 70403, Taiwan

Location

Taipei, 10048, Taiwan

Location

Taipei, 11217, Taiwan

Location

Related Publications (1)

Yoshikawa T, Muro K, Shitara K, Oh DY, Kang YK, Chung HC, Kudo T, Chin K, Kadowaki S, Hamamoto Y, Hironaka S, Yoshida K, Yen CJ, Omuro Y, Bai LY, Maeda K, Ozeki A, Yoshikawa R, Kitagawa Y. Effect of First-line S-1 Plus Oxaliplatin With or Without Ramucirumab Followed by Paclitaxel Plus Ramucirumab on Advanced Gastric Cancer in East Asia: The Phase 2 RAINSTORM Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e198243. doi: 10.1001/jamanetworkopen.2019.8243.
PMID: 31373648DERIVED

MeSH Terms

Interventions

RamucirumabS 1 (combination)OxaliplatinPaclitaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 2, 2015

Study Start

October 5, 2015

Primary Completion

October 25, 2017

Study Completion

March 10, 2021

Last Updated

March 8, 2022

Results First Posted

February 15, 2019

Record last verified: 2022-02

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

KR(6)TW(5)JP(23)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

S-1/Oxaliplatin + Ramucirumab

S-1/Oxaliplatin + Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (34)

Related Publications (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations