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Gastroesophageal Junction AdenocarcinomaPhase 3NCT02898077

A Study of Paclitaxel With or Without Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Cancer

A Phase 3 study testing Ramucirumab and Paclitaxel in people with Gastroesophageal Junction Adenocarcinoma and Gastric Adenocarcinoma, run by Eli Lilly and Company at 32 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy of the study drug known as ramucirumab in participants with gastric and gastroesophageal cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ramucirumab and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
440 participants
Where
32 sitesin 4 countries
Study dates
2 Mar 2017to 12 Apr 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have an Eastern Cooperative Oncology Group Performance Status (ECOGPS) of 0 or 1 at study entry.
  • Have a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma.
  • Have metastatic disease or locally advanced, unresectable disease.
  • Have at least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
  • Have experienced documented objective radiographic or symptomatic disease progression during first-line therapy, or within 4 months after the last dose of first-line therapy with any platinum/fluoropyrimidine doublet for unresectable or metastatic disease.
  • Have adequate organ function.
  • Have urinary protein ≤1+ on dipstick or routine urinalysis.

Who cannot join

  • Have undergone major surgery within 28 days prior to randomization.
  • Have received any first-line chemotherapy other than platinum and fluoropyrimidine with or without anthracycline for advanced gastric or GEJ adenocarcinoma.
  • Have received any previous systemic therapy (including investigational agents) targeting vascular endothelial growth factor (VEGF) or the VEGF receptor signaling pathways.
  • Have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to randomization.
  • Have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to study entry.
  • Have a history of GI perforation and/or fistulae within 6 months prior to randomization.
Show all 10Show fewer
  • Have experienced any arterial thromboembolic event within 6 months prior to randomization.
  • Have uncontrolled arterial hypertension (systolic blood pressure ≥160 millimeters of mercury [mmHg] or diastolic blood pressure ≥100 mmHg) despite standard medical management.
  • Have a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to randomization.
  • Have a serious illness or medical condition(s).

Trial locations and contacts

32 sites in 4 countries.

32 sites in 4 countries

China20 sites

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality, 100071

  • Beijing Cancer Hospital

    Beijing, 100142

  • Jilin Province Tumor Hospital

    Changchun, Jilin, 130012

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310016

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Nan Jing No. 81 Hospital

    Nanjing, Jiangsu, 210002

  • Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med

    Nanjing, Jiangsu, 210008

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060

  • Wuhan Union (Xiehe) Hospital

    Wuhan, Hubei, 430022

  • Wu Han Tongji Hospital

    Wuhan, Hubei, 430030

  • Tang Du Hospital, The Second Teaching Hospital of FMMU

    Xi’an, Shanxi, 710038

  • First hospital affiliated to Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

Malaysia5 sites

  • Advanced Medical & Dental Institute HUSM

    Kepala Batas, Pulau Pinang, 13200

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Umum Sarawak

    Kuching, Sarawak, 93586

  • National Cancer Institute

    Wilayah Persekutuan, 62250

Other trials in Malaysia

Thailand4 sites

  • Rajavithi Hospital

    Bangkok, Ratchathewi District, 10400

  • King Chulalongkorn Memoiral Hospsital

    Bangkok, 10330

  • Police General Hospital

    Bangkok, 10330

  • Khon Kaen Hospital

    Khon Kaen, 40000

Other trials in Thailand

Philippines3 sites

  • Dr. Pablo O. Torre Memorial Hospital

    Bacolod, 6100

  • De La Salle Health Sciences Institute

    Cavite City, 4114

  • Cebu Doctors Hospital

    Cebu City, Cebu, 6000

Other trials in Philippines

About this study

Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine

The purpose of this study is to evaluate the efficacy of the study drug known as ramucirumab in participants with gastric and gastroesophageal cancer.

Being tested
Ramucirumab, Paclitaxel, Placebo
Keywords
Second line, Angiogenesis, Vascular endothelial growth factor receptor 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamucirumabDrug

    Also called LY3009806

    Administered IV

  • PaclitaxelDrug

    Administered IV

  • PlaceboDrug

    Administered IV

Study groups in NCT02898077
Study groupRoleWhat they receive
8 milligram/kilogram (mg/kg) Ramucirumab + 80 mg/square meter (mg/m²) PaclitaxelExperimental8 mg/kg ramucirumab was administered as an intravenous infusion (IV) on days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on days 1, 8, and 15 of every 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.
Receives: Drug: Ramucirumab; Drug: Paclitaxel
Placebo + 80 mg/m² PaclitaxelExperimentalPlacebo was administered at a volume equivalent to a dose of 8 mg/kg by IV on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered by IV on Days 1, 8, and 15 of a 28-day cycle. Participants may continue on treatment until discontinuation criteria were met.
Receives: Drug: Paclitaxel; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

    Measured: Randomization to the Date of the First Radiographically Documented Progressive Disease or Death from Any Cause (Up To 30 Months)

  2. Overall Survival (OS)

    OS defined as the time from randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.

    Measured: Randomization to Date of Death from Any Cause (Up To 37 Months)

Secondary outcomes (7)

  1. Time to Progression (TTP)

    TTP was time from the date of randomization to the date of radiographic progression (according to RECIST v.1.1). If a participant died due to any reason without radiographic progression, TTP is censored at the last adequate tumor assessment. Target lesions: Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions: PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).

    Measured: Randomization to the Date of the First Radiographically Documented Progressive Disease (Up To 30 Months)

  2. Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])

    ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

    Measured: Randomization to Objective Disease Progression (Up To 30 Months)

  3. Duration of Objective Response (DoR)

    DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

    Measured: Date of Objective Response to the Date of the First Radiographically Documented Progressive Disease or Death Due to Any Cause (Up To 24 Months)

  4. Best Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures global health status, 5 functional domains (physical, role, cognitive, emotional, and social) and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 100 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. Least square (LS) mean value of changing from baseline to short-term follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline.

    Measured: Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)

  5. Worst Change From Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures global health status, 5 functional domains (physical, role, cognitive, emotional, and social) and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 100 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. LS Mean value of changing from baseline to short-term follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline.

    Measured: Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)

  6. Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score

    EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state.

    Measured: Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)

  7. Change From Baseline in Participant-Reported EQ-5D-3L Visual Analog Scale (VAS) Score

    EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. The EQ-5D VAS is used to record a participant's rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).

    Measured: Baseline, 30 Days After Treatment Discontinuation (Up To 20 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2016 (estimated)
  2. Study start2 Mar 2017
  3. Primary completion30 Jun 2020
  4. Study completion12 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02898077
Sponsor's protocol ID
15244
Other IDs
I4T-CR-JVCR
Status last verified
May 2022
First submitted
8 Sep 2016
Last updated
14 Jun 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Xu RH, Zhang Y, Pan H, Feng J, Zhang T, Liu T, Qin Y, Qin S, Yin X, Liu B, Ba Y, Yang N, Voon PJ, Tanasanvimon S, Zhou C, Zhang WL, Shen L. Efficacy and safety of weekly paclitaxel with or without ramucirumab as second-line therapy for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma (RAINBOW-Asia): a randomised, multicentre, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Dec;6(12):1015-1024. doi: 10.1016/S2468-1253(21)00313-7. Epub 2021 Oct 7.

    PubMed 34626550

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ramucirumab and Paclitaxel in people with Gastroesophageal Junction Adenocarcinoma and Gastric Adenocarcinoma, run by Eli Lilly and Company at 32 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in China, Malaysia, Thailand, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Randomization to the Date of the First Radiographically Documented Progressive Disease or Death from Any Cause (Up To 30 Months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02898077, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.

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