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

NCT ID: NCT01005355

Last Updated: 2014-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-02-28

Brief 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. The rationale for performing this trial is to establish the safety profile and the pharmacokinetics of IMC-1121B.

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMC-1121B

Participants receiving IMC-1121B intravenously

Group Type: EXPERIMENTAL

IMC-1121B

Intervention Type: BIOLOGICAL

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.

Interventions

IMC-1121B

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

RAMUCIRUMAB; LY3009806

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

• 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.)
• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal 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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

ImClone Investigational Site

Tokyo, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 28158463 (View on PubMed)

Other Identifiers

CP12-0816

Identifier Type: OTHER

Identifier Source: secondary_id

I4T-IE-JVBI

Identifier Type: OTHER

Identifier Source: secondary_id

13898

Identifier Type: -

Identifier Source: org_study_id