NCT02514551

Brief 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).

Trial Health

98
On Track

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2015

Typical duration for phase_2

Geographic Reach
11 countries

52 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

First Submitted

Initial submission to the registry

July 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 12, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 19, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2018

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

July 31, 2015

Results QC Date

August 23, 2018

Last Update Submit

June 10, 2020

Conditions

Gastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

Keywords

stomach cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Randomization to Objective Progressive Disease or Death (Up To 21 Months)

  • Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel

    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])

    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)]

    Baseline to Objective Progressive Disease (Up To 21 Months)

  • Number of Participants With Anti-Ramucirumab Antibodies

    Cycle 1 Predose through Follow-up (Up To 24 Months)

Study Arms (2)

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.

Drug: RamucirumabDrug: 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.

Drug: RamucirumabDrug: Paclitaxel

Interventions

RamucirumabDRUG

Administered IV

Also known as: LY3009806, IMC-1121B, Cyramza
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
PaclitaxelDRUG

Administered IV

12mg/kg Ramucirumab + 80 mg/m² Paclitaxel8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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.
  • +1 more criteria

You may not qualify if:

  • 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.
  • 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:
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (52)

City of Hope National Medical Center

Duarte, California, 91010-0269, United States

Location

University of Kansas Medical Center

Westwood, Kansas, 66205, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Scott & White Memorial Hospital & Clinic

Temple, Texas, 76508, United States

Location

Vista Oncology Inc. PS

Olympia, Washington, 98502, United States

Location

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.

Brussels, 1000, Belgium

Location

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Kortrijk, 8500, Belgium

Location

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Namur, 5000, Belgium

Location

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Calgary, T2N 4N2, Canada

Location

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Oshawa, L1G 2B9, Canada

Location

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Brno, 656 53, Czechia

Location

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Nový Jičín, 741 01, Czechia

Location

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Prague, 140 59, Czechia

Location

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Prague, 150 06, Czechia

Location

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Berlin, 13353, Germany

Location

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Frankfurt am Main, 60488, Germany

Location

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Hamburg, 20246, Germany

Location

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Ravensburg, 88212, Germany

Location

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Athens, 18537, Greece

Location

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Haidari, 12462, Greece

Location

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Heraklion, 71110, Greece

Location

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N. Efkarpia, 56403, Greece

Location

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Pátrai, 26504, Greece

Location

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Cagliari, 09042, Italy

Location

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Cremona, 26100, Italy

Location

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Faenza, 48018, Italy

Location

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Milan, 20089, Italy

Location

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Reggio Emilia, 42100, Italy

Location

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San Giovanni Rotondo, 71013, Italy

Location

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Barcelona, 08208, Spain

Location

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Barcelona, 17007, Spain

Location

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Girona, 17007, Spain

Location

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Madrid, 28041, Spain

Location

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Madrid, 28050, Spain

Location

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Málaga, 29010, Spain

Location

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Santander, 39008, Spain

Location

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Seville, 41013, Spain

Location

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Valencia, 46014, Spain

Location

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Gothenburg, 413 56, Sweden

Location

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Linköping, 58185, Sweden

Location

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Ankara, 06100, Turkey (Türkiye)

Location

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Edirne, 22770, Turkey (Türkiye)

Location

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Istanbul, 34098, Turkey (Türkiye)

Location

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Kayseri, 38039, Turkey (Türkiye)

Location

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Malatya, 44280, Turkey (Türkiye)

Location

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Dnipropetrovsk, 49102, Ukraine

Location

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Kyiv, 04107, Ukraine

Location

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Lutsk, 63000, Ukraine

Location

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Sumy, 40005, Ukraine

Location

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Vinnitsa, 21029, Ukraine

Location

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

RamucirumabPaclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2015

First Posted

August 3, 2015

Study Start

October 12, 2015

Primary Completion

October 27, 2017

Study Completion

December 28, 2018

Last Updated

June 17, 2020

Results First Posted

December 19, 2018

Record last verified: 2020-06-01

Data Sharing

IPD Sharing
Will share

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.

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.
More information

Locations

ES(9)CA(2)TU(5)CZ(4)IT(6)SE(2)DE(4)GR(5)UA(5)US(7)BE(3)