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

Lilly

Status and phase

Completed

Phase 1

Conditions

Metastasis

Malignancy

Treatments

Biological: Olaratumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01199822

21-3720 (Other Identifier)

CP15-0907 (Other Identifier)

13940

I5B-IE-JGDF (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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