Study of the Safety and Pharmacokinetics of Olaratumab (IMC-3G3) in Japanese Participants With Solid Tumors

NCT ID: NCT01199822

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-01-31

Brief Summary

Participants in this single-center, open-label, dose-escalation, Phase 1 study will initially receive intravenous (IV) olaratumab once every 2 weeks or on Days 1 and 8 every 3 weeks for 6 weeks (one cycle). After the first cycle, participants experiencing an overall response of complete response (CR), partial response (PR), or stable disease (SD) will continue to receive olaratumab at their cohort dose and schedule until there is evidence of progressive disease (PD), or until other withdrawal criteria are met.

Conditions

Malignancy; Metastasis

Study Design

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

Study Groups

Olaratumab

Group Type: EXPERIMENTAL

Olaratumab

Intervention Type: BIOLOGICAL

Cohort 1 10 milligrams/kilogram (mg/kg) intravenously (IV) administered on Days 1 and 8, every 3 weeks; Cohort 2 20 mg/kg IV administered every 2 weeks; Cohort 3 15 mg/kg IV administered on Days 1 and 8, every 3 weeks

Interventions

Olaratumab

Cohort 1 10 milligrams/kilogram (mg/kg) intravenously (IV) administered on Days 1 and 8, every 3 weeks; Cohort 2 20 mg/kg IV administered every 2 weeks; Cohort 3 15 mg/kg IV administered on Days 1 and 8, every 3 weeks

Intervention Type: BIOLOGICAL

Other Intervention Names

IMC-3G3; LY3012207

Eligibility Criteria

Inclusion Criteria

• Solid tumor that has been histopathologically or cytologically documented
• Advanced primary or recurrent solid tumor participants who has not responded to standard therapy or for whom no standard therapy is available
• Measurable or nonmeasurable lesions
• An Eastern Cooperative Oncology Group Performance Status score of 0-1
• Able to provide informed consent
• Has a life expectancy of >3 months
• Adequate hematologic function
• Adequate hepatic function
• Has adequate renal function
• Agrees to use adequate contraception for the duration of study participation and for at least 12 weeks after the last dose of study therapy
• Adequate recovery from recent surgery, chemotherapy, and radiation therapy (including palliative radiation therapy). At least 28 days (6 weeks for nitrosoureas or mitomycin C) must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. For treatment with non-approved monoclonal antibodies, a minimum of 8 weeks must have elapsed
• Is willing to comply with study procedures until the End-of-Therapy visit

Exclusion Criteria

• Received chemotherapy or therapeutic radiotherapy within 28 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or has ongoing side effects ≥ Grade 2 due to agents administered more than 28 days earlier
• Has undergone major surgery [example (e.g.), laparotomy, thoracotomy, removal of organ(s)] within 28 days prior to study entry
• Elective or planned surgery to be conducted during the trial
• Documented and/or symptomatic brain or leptomeningeal metastases (participants who are clinically stable [no symptoms during the 4 weeks prior to study entry] with an assessment that no further treatment [radiation, surgical excision, or administration of steroids] is required are permitted to enter the study)
• Uncontrolled intercurrent illness including, but not limited to:

• Active infection requiring systemic antibiotic treatment excluding oral administration [≥Grade 3 National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE Version (v) 4.02)]
• Congestive heart failure (Class III or IV per 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 (mm Hg), diastolic blood pressure >95 mm Hg]
• Cardiac arrhythmia requiring treatment (NCI-CTCAE v4.02, or asymptomatic sustained ventricular tachycardia
• Peripheral neuropathy of any etiology ≥Grade 2 (NCI-CTCAE v4.02); or
• Any other serious uncontrolled medical disorder(s) in the opinion of the investigator
• Participated in clinical studies of non-approved experimental agents or procedures within 4 weeks prior to study for small molecules, or 8 weeks prior to study entry for non-approved monoclonal antibodies
• Received any previous treatment with agents targeting the platelet-derived growth factor (PDGF) or platelet-derived growth factor receptor (PDGFR), approved or non-approved
• Known allergy to any of the treatment components (IMC-3G3, histidine, glycine, sodium chloride, mannitol, or polysorbate)
• If female, is pregnant (confirmed by urine or serum pregnancy test) or lactating
• Known alcohol or drug dependency
• Hepatitis B virus (HBV) antigen-, hepatitis C virus (HCV) antibody-, or human immunodeficiency (HIV) antibody-positive [asymptomatic healthy carriers with detectable HBV-Deoxyribonucleic acid (DNA), HCV-Ribonucleic acid (RNA) may be enrolled into the trial]
• Assessed as inadequate for the study by the investigator

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

Sponsors

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

Kashiwa, Chiba, Japan

Countries

Japan

Other Identifiers

CP15-0907

Identifier Type: OTHER

Identifier Source: secondary_id

I5B-IE-JGDF

Identifier Type: OTHER

Identifier Source: secondary_id

21-3720

Identifier Type: OTHER

Identifier Source: secondary_id

13940

Identifier Type: -

Identifier Source: org_study_id