AdenocarcinomaPhase 1NCT01253525

Study of Weekly Paclitaxel With Ramucirumab in Participants With Advanced Gastric Adenocarcinomas

A Phase 1 study testing Ramucirumab (IMC-1121B ) and Paclitaxel in people with Adenocarcinoma, run by Eli Lilly and Company at 3 sites in Japan.

Completed

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

Official record

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Trial summary

Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in combination with paclitaxel. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Adenocarcinoma
What is being tested?: Ramucirumab (IMC-1121B ) and Paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 3 sitesJapan
Study dates: Nov 2010to Oct 2011
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

Has a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma
Has an advanced or metastatic solid gastric adenocarcinoma that has failed standard therapy
Has resolution of all clinically significant toxic effects of prior therapy, surgery, treatment with an investigational agent or device, treatment monoclonal antibody or small molecule, and radiotherapy or chemotherapy.
Has adequate organ function
Eligible participants of reproductive potential (both sexes) agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for 12 weeks after the last dose of study medication

Who cannot join

Has undergone major surgery within 28 days prior to the study, or subcutaneous venous access device placement within 7 days prior to the study registration date
Has elective or planned surgery to be conducted during the trial
Has had treatment with an investigational agent or device, an antineoplastic small molecule, or antineoplastic radiotherapy or chemotherapy
Was previously treated with a chemotherapy regimen containing nitrosoureas or mitomycin C
Has had treatment with an antineoplastic monoclonal antibody within 8 weeks prior to the study registration date
Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism prior to the study registration date

Show all 17Show fewer

Has experienced any arterial thrombotic event, including myocardial infarction, cerebrovascular accident, or transient ischemic attack, within 6 months prior to the study date
Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents. (Participants receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters International Normalized Ratio (INR) ≤ 1.5, prothrombin time (PT) and partial thromboplastin time (PTT) or - Is receiving chronic therapy with nonsteroidal anti-inflammatory agents [Aspirin use at doses up to 325 milligrams/day (mg/day) is permitted]
Has significant bleeding disorders, vasculitis, history of postoperative bleeding complications, hemoptysis or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to the study date
Has a history of GI perforation and/or fistulae within 6 months prior to the study date
Has symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia
Has uncontrolled arterial hypertension despite standard medical management.
Has a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days prior to the study date
Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
Has a serious illness or medical condition(s)
Is pregnant or lactating
Has received treatment with another investigational drug or participation in another interventional clinical trial within 28 days prior to the study date

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

ImClone Investigational Site
Chiba, 277-8577
ImClone Investigational Site
Osaka, 569-8686
ImClone Investigational Site
Osaka, 589-5811

Other trials in Japan

About this study

Official title: A Phase 1b Study of Weekly Paclitaxel With Ramucirumab (IMC-1121B) Drug Product in Patients With Advanced Gastric Adenocarcinomas

Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in combination with paclitaxel.

Conditions: Adenocarcinoma
Being tested: Ramucirumab (IMC-1121B ), Paclitaxel
Keywords: Adenocarcinoma, Gastroesophageal Junction
Medical subject headings: Adenocarcinoma

What participants receive

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

Ramucirumab (IMC-1121B )Biological
Also called LY3009806, IMC-1121B
8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle
PaclitaxelDrug
80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle

Study groups in NCT01253525
Study group	Role	What they receive
Ramucirumab (IMC-1121B ) and Pacitaxel	Experimental	Each treatment cycle is 4 weeks (28 days) Receives: Biological: Ramucirumab (IMC-1121B ); Drug: Paclitaxel

What is being measured

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

Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1
DLT based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE v4.02) in Cycle (Cy) 1 due to study drug (SD) with (w/): Grade (Gr) ≥3 neutropenia w/fever ≥38.5°C or w/bacteremia or sepsis, thrombocytopenia w/bleeding and platelet substitution, prothrombin and/or partial thromboplastin time w/no anticoagulation, hyperbilirubinemia; Gr 4: neutropenia >5 days, thrombocytopenia, Gr 4 or uncontrollable hypertension QTc>500 milliseconds (ms) or increase ≥100 ms increase in 24 hours after SD or significant arrhythmia in this period; Gr ≥3 nonhematologic toxicity (tox), excluding Gr 3 hypersensitivity, hypertension, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea w/out loperamide/nausea/vomiting w/out antiemetic and transient aminotransferase elevation. SD tox=delay >1 week in ramucirumab (RAM) dose or omission of 1 dose of RAM or 2 paclitaxel doses due to tox in Cy 1 or delay >2 weeks between Cy 1 and Cy 2 due to persistent tox.
Measured: Cycle 1 of 28-day cycle
Number of Participants With Adverse Events (AEs)
The number of participants who experienced AEs of any grade, AEs of Grade ≥3 or AEs resulting in death that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC). A summary of serious adverse events (SAEs) and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.
Measured: Up to 47 weeks post baseline
Number of Participants With Serious Adverse Events (SAEs)
The number of participants who experienced SAEs that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC). A summary of SAEs and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.
Measured: Up to 47 weeks post baseline

Secondary outcomes (21)

Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1
Cmax after a single dose of ramucirumab (IMC-1121B).
Measured: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)
The percentage of participants who were treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies.
Measured: Cycle 1 through Cycle 5 (28-day cycles)
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1
AUC from time 0 to infinity (0-∞) after a single dose of ramucirumab (IMC-1121B).
Measured: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Half-Life (t1/2) for Cycle 1
Terminal t1/2 (the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%) after a single dose of ramucirumab (IMC-1121B).
Measured: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Clearance (CL) or Cycle 1
CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] after a single dose of ramucirumab (IMC-1121B).
Measured: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1
Vss [distribution of ramucirumab (IMC-1121B) in the body at steady state] after a single dose of ramucirumab (IMC-1121B).
Measured: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2
Cmax after multiple doses of ramucirumab (IMC-1121B).
Measured: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2
AUC within the dosing interval (0-τ) after multiple doses of ramucirumab (IMC-1121B).
Measured: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Half-Life (t1/2) for Cycle 2
Terminal t1/2 [the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%] after multiple doses of ramucirumab(IMC-1121B).
Measured: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Clearance (CL) for Cycle 2
CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] at steady state after multiple doses of ramucirumab (IMC-1121B).
Measured: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 2
Vss [distribution of ramucirumab (IMC-1121B) in in the body at steady state] is not calculated for multiple doses of ramucirumab (IMC-1121B).
Measured: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 3
Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 3.
Measured: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 3
Due to the sparse pharmacokinetic sampling ramucirumab (IMC-1121B) AUC within the dosing interval (0-τ) could not be calculated in Cycle 3.
Measured: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Half-Life (t 1/2) for Cycle 3
Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) t1/2 could not be calculated in Cycle 3.
Measured: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Clearance (CL) for Cycle 3
Due to sparse pharmacokinetic sampling CL could not be calculated for ramucirumab (IMC-1121B) in Cycle 3.
Measured: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 3
Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 3.
Measured: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 4
Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 4.
Measured: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 4
Due to sparse pharmacokinetic sampling AUC within the dosing interval (0-τ) for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
Measured: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Half-Life (t 1/2) for Cycle 4
Due to sparse pharmacokinetic sampling t1/2 for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
Measured: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Clearance (CL) for Cycle 4
Due to sparse pharmacokinetic sampling CL for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
Measured: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 4
Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.
Measured: Cycle 4: Pre-infusion, Day 1 of 28-day cycle

Timeline

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

Nov 2010Oct 2011

First posted3 Dec 2010 (estimated)
Study startNov 2010
Primary completionOct 2011
Study completionOct 2011

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01253525
Sponsor's protocol ID: 14204
Other IDs: CP12-1026, I4T-IE-JVBW
Status last verified: May 2014
First submitted: 2 Dec 2010
Last updated: 18 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ueda S, Satoh T, Gotoh M, Gao L, Doi T. A phase ib study of safety and pharmacokinetics of ramucirumab in combination with paclitaxel in patients with advanced gastric adenocarcinomas. Oncologist. 2015 May;20(5):493-4. doi: 10.1634/theoncologist.2014-0440. Epub 2015 Apr 17.
PubMed 25888272

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 Adenocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b Study of Weekly Paclitaxel With Ramucirumab (IMC-1121B) Drug Product in Patients With Advanced Gastric Adenocarcinomas
ClinicalTrials.gov ID: NCT01253525
Acronym / sponsor ID: 14204
Conditions: Adenocarcinoma
Keywords: Adenocarcinoma, Gastroesophageal Junction
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 3 Dec 2010 (estimated)
Results: Posted 18 Jun 2014

Clinical summary

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

Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in combination with paclitaxel.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ramucirumab (IMC-1121B ) and Pacitaxel	Experimental	Biological: Ramucirumab (IMC-1121B ), Drug: PaclitaxelEach treatment cycle is 4 weeks (28 days)

Who may qualify

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

Key inclusion criteria (5 listed)

Has a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma
Has an advanced or metastatic solid gastric adenocarcinoma that has failed standard therapy
Has resolution of all clinically significant toxic effects of prior therapy, surgery, treatment with an investigational agent or device, treatment monoclonal antibody or small molecule, and radiotherapy or chemotherapy.
Has adequate organ function
Eligible participants of reproductive potential (both sexes) agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for 12 weeks after the last dose of study medication

Key exclusion criteria (17 listed)

Has undergone major surgery within 28 days prior to the study, or subcutaneous venous access device placement within 7 days prior to the study registration date
Has elective or planned surgery to be conducted during the trial
Has had treatment with an investigational agent or device, an antineoplastic small molecule, or antineoplastic radiotherapy or chemotherapy
Was previously treated with a chemotherapy regimen containing nitrosoureas or mitomycin C
Has had treatment with an antineoplastic monoclonal antibody within 8 weeks prior to the study registration date

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
Ramucirumab (IMC-1121B )Also: LY3009806, IMC-1121B8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle	Biological	Ramucirumab (IMC-1121B ) and Pacitaxel
Paclitaxel80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle	Drug	Ramucirumab (IMC-1121B ) and Pacitaxel

Primary outcome

Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1
Time frame: Cycle 1 of 28-day cycle
DLT based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE v4.02) in Cycle (Cy) 1 due to study drug (SD) with (w/): Grade (Gr) ≥3 neutropenia w/fever ≥38.5°C or w/bacteremia or sepsis, thrombocytopenia w/bleeding and platelet substitution, prothrombin and/or partial thromboplastin time w/no anticoagulation, hyperbilirubinemia; Gr 4: neutropenia >5 days, thrombocytopenia, Gr 4 or uncontrollable hypertension QTc>500 milliseconds (ms) or increase ≥100 ms increase in 24 hours after SD or significant arrhythmia in this period; Gr ≥3 nonhematologic toxicity (tox), excluding Gr 3 hypersensitivity, hypertension, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea w/out loperamide/nausea/vomiting w/out antiemetic and transient aminotransferase elevation. SD tox=delay >1 week in ramucirumab (RAM) dose or omission of 1 dose of RAM or 2 paclitaxel doses due to tox in Cy 1 or delay >2 weeks between Cy 1 and Cy 2 due to persistent tox.
Number of Participants With Adverse Events (AEs)
Time frame: Up to 47 weeks post baseline
The number of participants who experienced AEs of any grade, AEs of Grade ≥3 or AEs resulting in death that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC). A summary of serious adverse events (SAEs) and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 47 weeks post baseline
The number of participants who experienced SAEs that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC). A summary of SAEs and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.

21 secondary outcomes

Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1
Time frame: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)
Time frame: Cycle 1 through Cycle 5 (28-day cycles)
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1
Time frame: Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Half-Life (t1/2) for Cycle 1
Time frame: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Clearance (CL) or Cycle 1
Time frame: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1
Time frame: Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2
Time frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2
Time frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Half-Life (t1/2) for Cycle 2
Time frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Clearance (CL) for Cycle 2
Time frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 2
Time frame: Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 3
Time frame: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 3
Time frame: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Half-Life (t 1/2) for Cycle 3
Time frame: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Clearance (CL) for Cycle 3
Time frame: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 3
Time frame: Cycle 3: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 4
Time frame: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 4
Time frame: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Half-Life (t 1/2) for Cycle 4
Time frame: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Clearance (CL) for Cycle 4
Time frame: Cycle 4: Pre-infusion, Day 1 of 28-day cycle
Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 4
Time frame: Cycle 4: Pre-infusion, Day 1 of 28-day cycle

Results and safety

Results posted to the registry on 18 Jun 2014, 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 + Paclitaxel	6	6

Primary outcome: Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1

Time frame: Cycle 1 of 28-day cycle. Number. Unit: participants

Measure	Ramucirumab + Paclitaxel n = 6
Value	0

Population analysed: All enrolled participants who complete the first cycle of study drug or discontinued study drug due to a DLT during Cycle 1.

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: Up to 47 weeks post baseline. Number. Unit: participants

Measure	Ramucirumab + Paclitaxel n = 6
RAM-Related AEs Any Grade	6
PAC-Related AEs Any Grade	6
RAM-Related AEs Any Grade ≥3	2
PAC-Related AEs Any Grade ≥3	4
RAM-Related AEs Resulting in Death	0
PAC-Related AEs Resulting in Death	0

Population analysed: All enrolled participants who received any quantity of study drug.

Primary outcome: Number of Participants With Serious Adverse Events (SAEs)

Time frame: Up to 47 weeks post baseline. Number. Unit: participants

Measure	Ramucirumab + Paclitaxel n = 6
RAM-Related SAEs	2
PAC-Related SAEs	2

Population analysed: All enrolled participants who received any quantity of study drug.

21 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ramucirumab + Paclitaxel	4 of 6 (66.7%)	6 of 6 (100%)	Not reported

Limitations and caveats (from the sponsor): Cycle 3 and beyond pharmacokinetic sampling was collected per the protocol-defined limited sampling schedule.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25888272Ueda S, Satoh T, Gotoh M, Gao L, Doi T. A phase ib study of safety and pharmacokinetics of ramucirumab in combination with paclitaxel in patients with advanced gastric adenocarcinomas. Oncologist. 2015 May;20(5):493-4. doi: 10.1634/theoncologist.2014-0440. Epub 2015 Apr 17.

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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

3 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 (IMC-1121B ) and Paclitaxel in people with Adenocarcinoma, run by Eli Lilly and Company at 3 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 5 inclusion and 17 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 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 18 Jun 2014). 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 a Dose-Limiting Toxicity (DLT) During Cycle 1 (time frame: Cycle 1 of 28-day cycle). The study lists 3 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 NCT01253525, 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 18 Jun 2014.