Stomach NeoplasmsPhase 1NCT02359058

A Study of Ramucirumab Combination Therapy in Japanese Participants Who Have Advanced Stomach Cancer

A Phase 1 study testing Ramucirumab, Capecitabine and Cisplatin in people with Stomach Neoplasms, run by Eli Lilly and Company at 4 sites in Japan.

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 main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and antitumor response of ramucirumab in combination with platinum/fluoropyrimidine regimens in Japanese participants with advanced gastric/gastrooesophageal junction cancer who have not received chemotherapy. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Stomach Neoplasms
What is being tested?: Ramucirumab, Capecitabine and Cisplatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 4 sitesJapan
Study dates: Feb 2015to Nov 2016
Phase: Phase 1
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma which is metastatic or locally advanced and unresectable. A participant with esophageal cancer is not eligible.
Not have received prior first-line systemic chemotherapy for locally advanced and unresectable and/or metastatic disease. Participants whose disease has progressed after >6 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
Measurable or nonmeasurable, but evaluable, disease, determined using guidelines in Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at the time of enrollment.
The participant has adequate organ function.
Resolution to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version [v]4.03) of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer.
Female participants of childbearing potential must have a negative serum or urinary pregnancy. Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator.

Who cannot join

A significant bleeding disorder, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to enrollment.
Uncontrolled arterial hypertension, despite standard medical management.
A serious or nonhealing wound or peptic ulcer or bone fracture at enrollment.
Undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device (reservoir) placement within 7 days prior to enrollment.
Radiation therapy within 14 days prior to enrollment.
Received any previous systemic therapy (including investigational agents) targeting vascular endothelial growth factor (VEGF) or the VEGF receptor signaling pathways.

Show all 13Show fewer

Cirrhosis at a level of Child-Pugh B (or worse); or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
A serious illness or medical condition(s).
Pregnant or breastfeeding.
Dysphagia for oral medication.
Known allergy or hypersensitivity to any study treatment.
Human epidermal growth factor receptor (HER) 2 status of positive.
Received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device.

Trial locations and contacts

4 sites in 1 country.

Japan4 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.
Aichi, 464-8681
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.
Chiba, 277-8577
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.
Ehime, 791-0280
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
Osaka, 565-0871

Other trials in Japan

About this study

Official title: Phase 1b Study of Ramucirumab in Combination With Fluoropyrimidines and Platinum-Based Agents in Japanese Patients With Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Conditions: Stomach Neoplasms
Being tested: Ramucirumab, Capecitabine, Cisplatin, S-1, Oxaliplatin
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
Administered IV
CapecitabineDrug
Administered orally
CisplatinDrug
Administered IV
S-1Drug
Administered orally
OxaliplatinDrug
Administered IV

Study groups in NCT02359058
Study group	Role	What they receive
Ramucirumab + Capecitabine + Cisplatin	Other	Ramucirumab (8 milligram per kilogram (mg/kg) given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met. Receives: Drug: Ramucirumab; Drug: Capecitabine; Drug: Cisplatin
Ramucirumab + S-1 + Cisplatin	Other	Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met. Receives: Drug: Ramucirumab; Drug: Cisplatin; Drug: S-1
Ramucirumab + S-1 + Oxaliplatin	Other	Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met. Receives: Drug: Ramucirumab; Drug: S-1; Drug: Oxaliplatin

What is being measured

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

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Measured: First Dose to Study Completion Plus 30-Day Safety Follow-Up (Up To 22 Months)

Secondary outcomes (4)

Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab
Maximum Serum Concentration (Cmax) of Ramucirumab.
Measured: Day 1, Day 8, Day 43, Day 50, Day 85 and Day 92: End of Infusion
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab
Minimum Serum Concentration (Cmin) of Ramucirumab.
Measured: Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 92 and Day 106: Pre-Dose
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
Objective response rate (ORR) was defined as the percentage of randomized participants achieving a best confirmed overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1). CR was defined as the disappearance of all target and non-target lesions. PR was 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 and no progression in non-target lesions.
Measured: First Dose to Date of Objective Progressive Disease or Death Due to Any Cause (Up To 22 Months)
Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies (TE-ADA)
Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.
Measured: First dose to study completion plus 30-day safety follow-up (Up To 22 Months)

Timeline

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

Feb 2015Nov 2016

First posted9 Feb 2015 (estimated)
Study startFeb 2015
Primary completionJul 2016
Study completionNov 2016

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 Stomach NeoplasmsStudies 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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02359058
Sponsor's protocol ID: 15532
Other IDs: I4T-JE-JVCX
Status last verified: Jul 2017
First submitted: 4 Feb 2015
Last updated: 24 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stomach Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1b Study of Ramucirumab in Combination With Fluoropyrimidines and Platinum-Based Agents in Japanese Patients With Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT02359058
Acronym / sponsor ID: 15532
Conditions: Stomach Neoplasms
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2015
Primary completion: Jul 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 9 Feb 2015 (estimated)
Results: Posted 4 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Ramucirumab + Capecitabine + Cisplatin	Other	Drug: Ramucirumab, Drug: Capecitabine, Drug: CisplatinRamucirumab (8 milligram per kilogram (mg/kg) given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
Ramucirumab + S-1 + Cisplatin	Other	Drug: Ramucirumab, Drug: Cisplatin, Drug: S-1Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
Ramucirumab + S-1 + Oxaliplatin	Other	Drug: Ramucirumab, Drug: S-1, Drug: OxaliplatinRamucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

A histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma which is metastatic or locally advanced and unresectable. A participant with esophageal cancer is not eligible.
Not have received prior first-line systemic chemotherapy for locally advanced and unresectable and/or metastatic disease. Participants whose disease has progressed after >6 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
Measurable or nonmeasurable, but evaluable, disease, determined using guidelines in Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at the time of enrollment.
The participant has adequate organ function.

Key exclusion criteria (13 listed)

A significant bleeding disorder, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to enrollment.
Uncontrolled arterial hypertension, despite standard medical management.
A serious or nonhealing wound or peptic ulcer or bone fracture at enrollment.
Undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device (reservoir) placement within 7 days prior to enrollment.
Radiation therapy within 14 days prior to enrollment.

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-1121BAdministered IV	Drug	Ramucirumab + Capecitabine + Cisplatin, Ramucirumab + S-1 + Cisplatin, Ramucirumab + S-1 + Oxaliplatin
CapecitabineAdministered orally	Drug	Ramucirumab + Capecitabine + Cisplatin
CisplatinAdministered IV	Drug	Ramucirumab + Capecitabine + Cisplatin, Ramucirumab + S-1 + Cisplatin
S-1Administered orally	Drug	Ramucirumab + S-1 + Cisplatin, Ramucirumab + S-1 + Oxaliplatin
OxaliplatinAdministered IV	Drug	Ramucirumab + S-1 + Oxaliplatin

Primary outcome

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: First Dose to Study Completion Plus 30-Day Safety Follow-Up (Up To 22 Months)
Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

4 secondary outcomes

Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab
Time frame: Day 1, Day 8, Day 43, Day 50, Day 85 and Day 92: End of Infusion
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab
Time frame: Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 92 and Day 106: Pre-Dose
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
Time frame: First Dose to Date of Objective Progressive Disease or Death Due to Any Cause (Up To 22 Months)
Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies (TE-ADA)
Time frame: First dose to study completion plus 30-day safety follow-up (Up To 22 Months)

Results and safety

Results posted to the registry on 4 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ramucirumab + Capecitabine + Cisplatin	6	6
Ramucirumab + S-1 + Cisplatin	6	6
Ramucirumab + S-1 + Oxaliplatin	6	6

Primary outcome: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame: First Dose to Study Completion Plus 30-Day Safety Follow-Up (Up To 22 Months). Count of participants. Unit: Participants

Measure	Ramucirumab + Capecitabine + Cisplatin n = 6	Ramucirumab + S-1 + Cisplatin n = 6	Ramucirumab + S-1 + Oxaliplatin n = 6
Value	1	2	2

Population analysed: All enrolled participants who received at least one dose of study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose to study completion plus 30-day safety follow-up (Up To 22 Months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ramucirumab + Capecitabine + Cisplatin	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
Ramucirumab + S-1 + Cisplatin	2 of 6 (33.3%)	6 of 6 (100%)	Not reported
Ramucirumab + S-1 + Oxaliplatin	2 of 6 (33.3%)	5 of 6 (83.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) study director

Eli Lilly and Company

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ramucirumab, Capecitabine and Cisplatin in people with Stomach Neoplasms, run by Eli Lilly and Company at 4 sites in Japan.

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 13 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 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 4 Dec 2017). 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?

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: First Dose to Study Completion Plus 30-Day Safety Follow-Up (Up To 22 Months)). 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 NCT02359058.

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 24 Jan 2018.