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Advanced Solid TumorsPhase 1NCT01005355

Study of IMC-1121B in Patients With Advanced Solid Tumors

A Phase 1 study testing IMC-1121B in people with Advanced Solid Tumors, run by Eli Lilly and Company at 1 site 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

This trial is testing the investigational drug IMC-1121B administered to Japanese participants with advanced solid tumors who have not responded to standard therapy or for whom no standard therapy is available. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
IMC-1121B
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteJapan
Study dates
Sep 2009to Feb 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

  • Solid tumor participant who was been histopathologically or cytologically documented.
  • Advanced primary or recurrent solid tumors participant who has not responded to standard therapy or no standard therapy is available.
  • The participant has measurable or nonmeasurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST).
  • The participant has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 at study entry.
  • The participant is able to provide written informed consent.
  • The participant is age 20 years or older.
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  • The participant has a life expectancy of > 3 months.
  • The participant has adequate hematologic function, as defined by:
  • An absolute neutrophil count (ANC) > 1500/cubic millimeter (mm³) or /microliter (µL)
  • A hemoglobin level > 10 grams/deciliter (g/dL)
  • A platelet count > 100,000/mm³ or /µL
  • The participant has adequate hepatic function, as defined by:
  • A total bilirubin level < 1.8 milligrams/deciliter (mg/dL)
  • Aspartate transaminase (AST) levels < 86 International Units/liter (IU/L)
  • Alanine transaminase (ALT) levels ≤ 86 IU/L
  • The participant has adequate renal function, as defined by:
  • Serum creatinine level ≤ 1.5 mg/dL, or
  • Calculated serum creatinine clearance (Cockcroft-Gault) ≥ 60 milliliters/minute (mL/min)
  • The participant's urinary protein is 0 on dipstick or 1+ but participant does not have edema nor serum albumin < lower level of normal (LLN).
  • The participant has adequate coagulation function, as defined by international normalized ratio (INR) ≤ 1.5.
  • The participant agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study treatment.

Who cannot join

  • The participant has had chemotherapy or therapeutic radiotherapy within 28 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or participant has ongoing side effects ≥ Grade 2 due to agents administered more than 28 days earlier.
  • The participant has obvious evidence of intratumor cavitation.
  • The participant has undergone major surgery (example, laparotomy, thoracotomy, removal of organ[s]) within 28 days prior to study entry, or subcutaneous venous access device placement within 7 days prior to study entry.
  • The participant has a history of postoperative bleeding complications or wound complications from a surgical procedure.
  • The participant has elective or planned surgery to be conducted during the trial.
  • The participant has documented and/or symptomatic brain or leptomeningeal metastases. (Participants who are clinically stable [no symptoms during 4 weeks prior to the enrollment] with an assessment that no further treatment [radiation, surgical excision, and administration of steroids] is required, are permitted to enter the study.)
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  • The participant has uncontrolled intercurrent illness including, but not limited to:
  • Thrombotic or hemorrhagic disorders
  • Hemoptysis (approximately one-half of a teaspoon)
  • Ongoing or active infection requiring systemic antibiotic treatment
  • Congestive heart failure (Class III or IV of the New York Heart Association classification for heart disease)
  • Angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
  • Uncontrolled hypertension (systolic blood pressure > 150 millimeters of mercury (mmHg), diastolic blood pressure > 95 mm Hg)
  • Cardiac arrhythmia requires treatment [National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), Grade 3], or asymptomatic sustained ventricular tachycardia)
  • Peripheral neuropathy of any etiology ≥ Grade 2 (NCI-CTCAE v 3.0)
  • The participant has participated in clinical studies of non-approved experimental agents or procedures within 4 weeks prior to study entry for small molecules, or 8 weeks prior to study entry for non-approved monoclonal antibodies.
  • The participant, if female, is pregnant (confirmed by urine or serum pregnancy test) or lactating.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • ImClone Investigational Site

    Tokyo, 104-0045

Other trials in Japan

About this study

Official title: Phase 1 Study of IMC-1121B in Patients With Advanced Solid Tumors

This trial is testing the investigational drug IMC-1121B administered to Japanese participants with advanced solid tumors who have not responded to standard therapy or for whom no standard therapy is available. The rationale for performing this trial is to establish the safety profile and the pharmacokinetics of IMC-1121B.

Read the detailed description

This single center, open-label, single-arm, Phase 1 study will enroll approximately 15 to 18 participants. The actual size will vary depending on the dose-limiting toxicities (DLTs) observed and the resultant sizes of the cohorts. Participants will receive IMC-1121B, administered intravenously, once every 2 or 3 weeks for 6 weeks (one cycle). After one cycle of treatment, participants who have an objective response or stable disease may continue to receive IMC-1121B at the same dose and schedule until disease progression or other withdrawal criteria are met. A minimum of three participants will be enrolled in each cohort. Dose escalation in successive cohorts will occur once all participants complete one cycle of therapy.

Participants will be enrolled sequentially into each cohort.

A completed participant will be either a participant who completes the initial 6 week treatment period (Cycle 1) or a participant who discontinues therapy for an IMC-1121B related toxicity during Cycle 1. Participants who do not complete the first 6 weeks of treatment for reasons other than an IMC-1121B -related toxicity will be replaced. Toxicity data for each cohort will be reviewed prior to dose escalation. Upon completion of all required safety evaluations during the initial 6 weeks, the next cohort of new participants will be treated at the next higher dose level using a dose escalation scheme.

Being tested
IMC-1121B
Keywords
Solid tumor, recombinant human IgG1, MAB, monoclonal antibody, VEGFR 2, human vascular endothelial growth factor receptor 2

What participants receive

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

  • IMC-1121BBiological

    Also called RAMUCIRUMAB, LY3009806

    Cycle 1: Upon completion of enrollment criteria confirmed at screening, the first dose of study medication should be administered within 7 days. The infusion will be planned every 2 weeks or every 3 weeks on the same day of the week of the first infusion. Dose escalation to Cohort 2 may occur in the absence of a dose-limiting toxicity (DLT) in the first three participants treated in Cohort 1 during the initial 6-week dosing period (Cycle 1). The same procedure will be followed for dose escalation from Cohort 2 to Cohort 3. If 1 of 3 participants in any cohort experiences a DLT in the first 6 weeks (Cycle 1), 3 additional participants will be enrolled in that cohort. Dose escalation to the next cohort may occur if less that 2 of 6 participants experience a DLT during Cycle 1.

Study groups in NCT01005355
Study groupRoleWhat they receive
IMC-1121BExperimentalParticipants receiving IMC-1121B intravenously
Receives: Biological: IMC-1121B

What is being measured

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

  1. Number of Participants With Drug-Related Adverse Events

    Data presented are the number of participants who experienced adverse events (AE) of any grade, AE of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), serious adverse events (SAE) and AE resulting in death that was considered to be related to IMC-1121B (ramucirumab). A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

    Measured: Baseline to study completion up to 48 weeks

  2. IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohorts 1 and 2 During Cycles 1 and 2

    Measured: Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle

  3. IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohorts 1 and 2 During Cycles 3 to 5

    Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Cmax could not be calculated.

    Measured: Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose

  4. IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) Versus Time Curve - Cohorts 1 and 2 During Cycles 1 and 2

    AUC for Cycle 1 is AUC from time zero to infinity [AUC(0-∞)] and for Cycle 2 is AUC over a dosing interval (AUCτ).

    Measured: Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle

  5. IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) - Cohorts 1 and 2 During Cycles 3 to 5

    Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, AUC could not be calculated.

    Measured: Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose

  6. IMC-1121B Pharmacokinetics: Half-Life (t1/2) - Cohorts 1 and 2 During Cycles 1 and 2

    Measured: Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle

  7. IMC-1121B Pharmacokinetics: Half-Life (t 1/2) - Cohorts 1 and 2 During Cycles 3 to 5

    Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, t1/2 could not be calculated.

    Measured: Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose

  8. IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohorts 1 and 2 During Cycles 1 and 2

    Measured: Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle

  9. IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohorts 1 and 2 During Cycles 3 to 5

    Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Vss could not be calculated.

    Measured: Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose

  10. IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohort 3 During Cycles 1 and 2

    Measured: Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle

  11. IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohort 3 During Cycles 3 to 5

    Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Cmax could not be calculated.

    Measured: Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose

  12. IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) - Cohort 3 During Cycles 1 and 2

    AUC for Cycle 1 is AUC from time zero to infinity [AUC(0-∞)] and for Cycle 2 is AUC over a dosing interval (AUCτ).

    Measured: Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle

  13. IMC-1121B Pharmacokinetics - Area Under the Concentration (AUC) - Cohort 3 During Cycles 3 to 5

    Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, AUC could not be calculated.

    Measured: Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose

  14. IMC-1121B Pharmacokinetics: Half-Life (t1/2) - Cohort 3 During Cycles 1 and 2

    Measured: Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle

  15. IMC-1121B Pharmacokinetics: Half-Life (t 1/2) - Cohort 3 During Cycles 3 to 5

    Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, t1/2 could not be calculated.

    Measured: Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose

  16. IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohort 3 During Cycles 1 and 2

    Measured: Day 1 and Day 22 of Cycles 1 and 2 of a 6-week cycle

  17. IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohort 3 During Cycles 3 to 5

    Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Vss could not be calculated.

    Measured: Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour post-dose

Secondary outcomes (1)

  1. Screen for the Development of Circulating Antibodies Against IMC-1121B (Immunogenicity)

    Data presented are the number of participants with treatment emergent antibody positive.

    Measured: Baseline to study completion up to 48 weeks

Timeline

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

  1. First posted30 Oct 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01005355
Sponsor's protocol ID
13898
Other IDs
CP12-0816, I4T-IE-JVBI
Status last verified
May 2014
First submitted
5 Oct 2009
Last updated
18 Jun 2014
Data monitoring committee
Yes

Publications

  • Nokihara H, Yamamoto N, Yamada Y, Honda K, Asahina H, Tamura Y, Hozak RR, Gao L, Suzukawa K, Enatsu S, Tamura T. A phase 1 study of ramucirumab in Japanese patients with advanced solid tumors. Jpn J Clin Oncol. 2017 Apr 1;47(4):298-305. doi: 10.1093/jjco/hyx008.

    PubMed 28158463

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMC-1121B in people with Advanced Solid Tumors, run by Eli Lilly and Company at 1 site 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 21 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 1 site 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 Drug-Related Adverse Events (time frame: Baseline to study completion up to 48 weeks). The study lists 17 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 NCT01005355, 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.

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