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

NCT ID: NCT02539225

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-05
• Study Completion Date: 2021-03-10

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.

Conditions

Metastatic Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

S-1/Oxaliplatin + Ramucirumab

(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.

Group Type: EXPERIMENTAL

Ramucirumab

Intervention Type: DRUG

Administered IV

S-1

Intervention Type: DRUG

Administered PO

Oxaliplatin

Intervention Type: DRUG

Administered IV

Paclitaxel

Intervention Type: DRUG

Administered IV

S-1/Oxaliplatin + Placebo

(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.

Group Type: ACTIVE_COMPARATOR

Ramucirumab

Intervention Type: DRUG

Administered IV

Placebo

Intervention Type: DRUG

Administered IV

S-1

Intervention Type: DRUG

Administered PO

Oxaliplatin

Intervention Type: DRUG

Administered IV

Paclitaxel

Intervention Type: DRUG

Administered IV

Interventions

Ramucirumab

Administered IV

Intervention Type: DRUG

Placebo

Administered IV

Intervention Type: DRUG

S-1

Administered PO

Intervention Type: DRUG

Oxaliplatin

Administered IV

Intervention Type: DRUG

Paclitaxel

Administered IV

Intervention Type: DRUG

Other Intervention Names

LY3009806; IMC-1121B; Cyramza

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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, , Japan

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Bunkyō City, , Japan

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Chiba, , Japan

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Gifu, , Japan

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Kochi, , Japan

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Kōtoku, , Japan

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Kōtoku, , Japan

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Kumamoto, , Japan

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Nagoya, , Japan

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Nagoya, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Sagamihara, , Japan

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Sakai, , Japan

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Sapporo, , Japan

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Shinjuku-Ku, , Japan

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Suita-shi, , Japan

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Takatsuki, , Japan

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Toyonaka, , Japan

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Utsunomiya, , Japan

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Yokohama, , Japan

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Yokohama, , Japan

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Ulsan, , South Korea

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Kuei Shan Hsiang, , Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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.

Taipei, , Taiwan

Countries

Japan; South Korea; Taiwan

References

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.

Reference Type: DERIVED

PMID: 31373648 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lillytrialguide.com/en-US/trial/1iuJn3anbEq6WK6y64aEY4

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

Other Identifiers

I4T-JE-JVCW

Identifier Type: OTHER

Identifier Source: secondary_id

15461

Identifier Type: -

Identifier Source: org_study_id