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Phase 2 N=148 Randomized Treatment

A Study of Olaratumab in Soft Tissue Sarcoma

Sarcoma, Soft Tissue

Enrolled (actual)
148
Serious AEs
39.7%
Results posted
Apr 2017
Primary outcome: Primary: Progression-free Survival (PFS) — 6.6; 4.1 Month — p=0.0615

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Olaratumab (Biological); doxorubicin (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Eli Lilly and Company
Primary completion
Aug 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-free Survival (PFS)
6.6; 4.1 0.0615
PRIMARY
Number of Participants With Treatment Related Adverse Events (TEAE), Adverse Events (AE) or Serious Adverse Events (SAE) for Safety for the Phase 1b Portion of the Study
14; 7
SECONDARY
Number of Participants With AEs and SAEs for Phase 2 Portion
63; 64; 24; 27; 26; 9
SECONDARY
Overall Survival (OS)
26.5; 14.7 0.0003 sig
SECONDARY
Percentage of Participants With Objective Response (Objective Response Rate)
18.2; 11.9; 0
SECONDARY
Percentage of Participants Who Are Progression-Free (PFS) at 3 Months
69.0; 59.9
SECONDARY
Pharmacokinetic (PK) Maximum Concentration (Cmax) Cycle 1 Day 1, Cycle 3 Day 1 of Olaratumab
284; 404
SECONDARY
PK: Minimum Concentration (Cmin) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab
66.5; 123
SECONDARY
PK: Area Under Concentration Curve Versus Time (AUCτ) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab
39200; 47300
SECONDARY
PK: Half-Life (T1/2) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab
6.70; 9.80
SECONDARY
Percentage of Participants With Anti-Olaratumab Antibody Assessment
9.1; 5.2; 6.3

Summary

The main purpose of this study is to gather information about the use of an investigational drug called olaratumab with a drug for soft tissue sarcoma called doxorubicin.

Eligibility Criteria

Inclusion Criteria

  • The participant has histologically- or cytologically-confirmed malignant soft tissue sarcoma
  • The participant has advanced soft tissue sarcoma (STS), not amenable to treatment with surgery or radiotherapy
  • The participant's Eastern Cooperative Oncology Group (ECOG) performance status is 0-2
  • The participant has available tumor tissue from either the primary or metastatic tumor for determination of PDGFRα expression
  • The participant has adequate hematologic function as defined by an absolute neutrophil count (ANC) ≥ 1500 μL, hemoglobin ≥ 9.0 g/dL, and a platelet count of 100,000/μL obtained within 2 weeks prior to study entry
  • The participant has adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper limit of normal (ULN)
  • The participant has adequate renal function as defined by serum creatinine ≤ 1.5 × the institutional ULN. If creatinine is above the ULN, the participant's creatinine clearance is ≥ 45 mL/min
  • Because the teratogenicity of Olaratumab is not known, women of childbearing potential (WOCBP) and sexually active males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

Exclusion Criteria

  • The participant has histologically- or cytologically-confirmed Kaposi's sarcoma
  • The participant has untreated central nervous system metastases
  • The participant received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones (ie, mitoxantrone)
  • The participant received prior radiation therapy to the mediastinal/pericardial area
  • The participant has a history of another primary cancer, with the exception of a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to study entry
  • The participant is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent
  • The participant has an elective or a planned major surgery to be performed during the course of the study
  • The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, requiring parenteral antibiotics, symptomatic congestive heart failure, severe myocardial insufficiency, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • The participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months prior to study entry
  • The participant has known immunodeficiency virus (HIV) infection
  • The participant, if female, is pregnant or lactating
  • The participant has a known allergy to any of the treatment components
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01185964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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