Gastric AdenocarcinomaPhase 2NCT02514551
A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer
A Phase 2 study testing Ramucirumab and Paclitaxel in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Eli Lilly and Company at 52 sites in 11 countries.
Trial summary
The main purpose of this study is to evaluate the efficacy of an alternative dose of ramucirumab in combination with paclitaxel in participants with second-line metastatic or locally advanced, unresectable gastric or gastroesophageal junction adenocarcinoma (GEJ). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Ramucirumab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 52 sitesin 11 countries
- Study dates
- 12 Oct 2015to 28 Dec 2018
- Phase
- Phase 2
- 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
- The participant has a diagnosis of gastric or GEJ adenocarcinoma.
- The participant has disease progression during or within 4 months after last dose of first-line chemotherapy or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.
- The participant received combination chemotherapy, which must include a platinum and/or a fluoropyrimidine and must not include a taxane or antiangiogenic agent.
- The disease is evaluable by imaging per Response Evaluation Criteria in Solid Tumors 1.1.
- The participant has an Eastern Cooperative Oncology Group performance status of 0 or 1.
- The participant has adequate organ function:
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- Total bilirubin ≤1.5 × the upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN. If the liver has tumor involvement, AST and ALT <5 × ULN.
- Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥50 milliliters/minute.
- Urinary protein is <2+.
- Absolute neutrophil count ≥1.5 × 10^9/liter (L), platelets ≥100 × 10^9/L, and hemoglobin ≥9 grams/deciliter (5.58 millimoles/L).
- International normalized ratio ≤1.5 × ULN and partial thromboplastin time ≤5 seconds above ULN.
- The participant has an estimated life expectancy of minimum 12 weeks.
- The participant has resolution to Grade 1 or less by Common Terminology Criteria for Adverse Events Version 4.0, of all clinically significant toxic effects of previous therapy.
- The participant, if male, is sterile or agrees to use a reliable method of birth control.
- The participant, if female, is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control.
- The participant, if female and of child-bearing potential, must have a negative pregnancy test.
Who cannot join
- The participant is receiving therapy with any of the following:
- Nonsteroidal anti-inflammatory agents.
- Other anti-platelet agents; Aspirin use at doses up to 325 milligrams (mg)/day is permitted.
- The participant received radiotherapy within 14 days prior to randomization.
- The participant received previous chemotherapy with a cumulative dose of >900 mg per meter squared (mg/m^2) of epirubicin or >400 mg/m^2 of doxorubicin.
- The participant has documented brain metastases or leptomeningeal disease.
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- The participant has a significant bleeding disorder or vasculitis.
- The participant experienced any arterial thromboembolic event within 6 months.
- The participant has symptomatic congestive heart failure or symptomatic cardiac arrhythmia.
- The participant has uncontrolled hypertension, despite antihypertensive intervention.
- The participant underwent major surgery within 28 days.
- The participant has a history of gastrointestinal perforation or fistula within 6 months.
- The participant has a history of inflammatory bowel disease or Crohn's disease requiring medical intervention within 12 months.
- The participant has bowel obstruction or history of chronic diarrhea that is considered clinically significant.
- The participant has either of the following:
- Child-pugh B or C cirrhosis.
- The participant has a serious illness or medical condition including:
- Human immunodeficiency virus infection.
- The participant has a concurrent active malignancy other than the following:
- Nonmelanomatous skin cancer.
- In situ carcinoma of the cervix or other noninvasive carcinoma or in situ neoplasm.
- The participant has a serious nonhealing: (a) wound, (b) peptic ulcer, or (c) bone fracture.
- The participant experienced any Grade 3 or 4 venous thromboembolic event that is not adequately treated.
Trial locations and contacts
52 sites in 11 countries.
52 sites in 11 countries
Spain9 sites
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.
Barcelona, 08208
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Barcelona, 17007
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Girona, 17007
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Madrid, 28041
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Madrid, 28050
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Málaga, 29010
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Santander, 39008
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Seville, 41013
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Valencia, 46014
United States7 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
City of Hope National Medical Center
Duarte, California, 91010-0269
Weill Cornell Medical College
New York, New York, 10021
Vista Oncology Inc. PS
Olympia, Washington, 98502
Scott & White Memorial Hospital & Clinic
Temple, Texas, 76508
Montefiore Medical Center
The Bronx, New York, 10461
University of Kansas Medical Center
Westwood, Kansas, 66205
Italy6 sites
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Cagliari, 09042
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Cremona, 26100
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Faenza, 48018
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Milan, 20089
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Reggio Emilia, 42100
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San Giovanni Rotondo, 71013
Greece5 sites
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Athens, 18537
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Haidari, 12462
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Heraklion, 71110
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N. Efkarpia, 56403
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Pátrai, 26504
Turkey (Türkiye)5 sites
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Ankara, 06100
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Edirne, 22770
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Istanbul, 34098
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Kayseri, 38039
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Malatya, 44280
Ukraine5 sites
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Dnipropetrovsk, 49102
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Kyiv, 04107
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Lutsk, 63000
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Sumy, 40005
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Vinnitsa, 21029
Czechia4 sites
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Brno, 656 53
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Nový Jičín, 741 01
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Prague, 140 59
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Prague, 150 06
Germany4 sites
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Berlin, 13353
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Frankfurt am Main, 60488
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Hamburg, 20246
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Ravensburg, 88212
Belgium3 sites
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Brussels, 1000
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Kortrijk, 8500
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Namur, 5000
Canada2 sites
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Calgary, T2N 4N2
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Oshawa, L1G 2B9
Sweden2 sites
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Gothenburg, 413 56
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Linköping, 58185
About this study
Official title: Randomized Phase 2 Trial Evaluating Alternative Ramucirumab Doses in Combination With Paclitaxel in Second-Line Metastatic or Locally Advanced, Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma
The main purpose of this study is to evaluate the efficacy of an alternative dose of ramucirumab in combination with paclitaxel in participants with second-line metastatic or locally advanced, unresectable gastric or gastroesophageal junction adenocarcinoma (GEJ).
- Being tested
- Ramucirumab, Paclitaxel
- Keywords
- stomach cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamucirumabDrug
Also called LY3009806, IMC-1121B, Cyramza
Administered IV
PaclitaxelDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Experimental | 12 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 milligram per square meter (mg/m²) paclitaxel administered IV on day 1, day 8 and day 15. Receives: Drug: Ramucirumab; Drug: Paclitaxel |
| 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Active comparator | 8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15. Receives: Drug: Ramucirumab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZ
PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment (AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.
Measured: Randomization to Objective Progressive Disease or Death (Up To 21 Months)
Secondary outcomes (5)
Progression Free Survival (PFS) Ramucirumab 12mg/kg Arm and 8mg/kg Arm in I4T-MC-JVCZ
PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment(AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.
Measured: Randomization to Objective Progressive Disease or Death (Up To 21 Months)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination with Paclitaxel
Measured: Cycle(C) 1 Day(D) 1: Prior to Infusion(PTI),1 to 1.5 hours(hrs) after end of Infusion(EOI); C1 D15: 3 days PTI; C2 D1: 3 days PTI; C2 D15: 3 days PTI,1 to 1.5 hrs after EOI; C3 D1 and 15: 3 days PTI; C4 D1: 3 days PTI and 1 to 1.5 hrs after EOI
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])
ORR was defined as the percentage of participants who achieved a PR or CR per RECIST v.1.1.CR is the disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to<10mm.Tumor marker results must have normalized.PR is at least a 30% decrease in the sum of diameter of target lesions,taking as reference the baseline sum diameters.ORR is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Measured: Baseline to Objective Progressive Disease (Up To 21 Months)
Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)]
DCR is defined as the percentage of participants who achieved CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm.Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression. Non-Target PD is unequivocal progression of existing nontarget lesions. DCR=CR+PR+SD/total number of participants*100.
Measured: Baseline to Objective Progressive Disease (Up To 21 Months)
Number of Participants With Anti-Ramucirumab Antibodies
Participants who had anti-ramucirumab antibodies at postbaseline.
Measured: Cycle 1 Predose through Follow-up (Up To 24 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study start12 Oct 2015
- Primary completion27 Oct 2017
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514551
- Sponsor's protocol ID
- 15541
- Other IDs
- I4T-MC-JVCZ, 2014-005067-32, 2014
- Status last verified
- 1 Jun 2020
- First submitted
- 31 Jul 2015
- Last updated
- 17 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 2 Trial Evaluating Alternative Ramucirumab Doses in Combination With Paclitaxel in Second-Line Metastatic or Locally Advanced, Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02514551
- Acronym / sponsor ID
- 15541
- Keywords
- stomach cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2015 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 3 Aug 2015 (estimated)
- Results
- Posted 19 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the efficacy of an alternative dose of ramucirumab in combination with paclitaxel in participants with second-line metastatic or locally advanced, unresectable gastric or gastroesophageal junction adenocarcinoma (GEJ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Experimental | Drug: Ramucirumab, Drug: Paclitaxel12 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 milligram per square meter (mg/m²) paclitaxel administered IV on day 1, day 8 and day 15. |
| 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Active comparator | Drug: Ramucirumab, Drug: Paclitaxel8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The participant has a diagnosis of gastric or GEJ adenocarcinoma.
- The participant has disease progression during or within 4 months after last dose of first-line chemotherapy or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.
- The participant received combination chemotherapy, which must include a platinum and/or a fluoropyrimidine and must not include a taxane or antiangiogenic agent.
- The disease is evaluable by imaging per Response Evaluation Criteria in Solid Tumors 1.1.
- The participant has an Eastern Cooperative Oncology Group performance status of 0 or 1.
Key exclusion criteria (23 listed)
- The participant is receiving therapy with any of the following:
- The participant received radiotherapy within 14 days prior to randomization.
- The participant received previous chemotherapy with a cumulative dose of >900 mg per meter squared (mg/m^2) of epirubicin or >400 mg/m^2 of doxorubicin.
- The participant has documented brain metastases or leptomeningeal disease.
- The participant has a significant bleeding disorder or vasculitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamucirumabAlso: LY3009806, IMC-1121B, CyramzaAdministered IV | Drug | 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel, 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel |
| PaclitaxelAdministered IV | Drug | 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel, 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel |
Primary outcome
Progression Free Survival (PFS) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZ
Time frame: Randomization to Objective Progressive Disease or Death (Up To 21 Months)
PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment (AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.
5 secondary outcomes
Progression Free Survival (PFS) Ramucirumab 12mg/kg Arm and 8mg/kg Arm in I4T-MC-JVCZ
Time frame: Randomization to Objective Progressive Disease or Death (Up To 21 Months)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel
Time frame: Cycle(C) 1 Day(D) 1: Prior to Infusion(PTI),1 to 1.5 hours(hrs) after end of Infusion(EOI); C1 D15: 3 days PTI; C2 D1: 3 days PTI; C2 D15: 3 days PTI,1 to 1.5 hrs after EOI; C3 D1 and 15: 3 days PTI; C4 D1: 3 days PTI and 1 to 1.5 hrs after EOI
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])
Time frame: Baseline to Objective Progressive Disease (Up To 21 Months)
Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)]
Time frame: Baseline to Objective Progressive Disease (Up To 21 Months)
Number of Participants With Anti-Ramucirumab Antibodies
Time frame: Cycle 1 Predose through Follow-up (Up To 24 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
52 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ramucirumab and Paclitaxel in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Eli Lilly and Company at 52 sites in 11 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 16 inclusion and 23 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 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Spain, United States, Italy, Greece, Turkey (Türkiye) and 6 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 19 Dec 2018). 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) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZ (time frame: Randomization to Objective Progressive Disease or Death (Up To 21 Months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2020.