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Monoclonal Antibodies

Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel for Soft Tissue Sarcoma (ANNOUNCE 2 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through follow-up (up to 38 months)

Summary

The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma (STS) or STS that has spread to another part(s) of the body.

Eligible Conditions
  • Soft Tissue Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through follow-up (up to 38 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through follow-up (up to 38 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT)
Phase 2: Overall Survival (OS) (Olaratumab-Naive)
Secondary study objectives
Phase 1b/2: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Docetaxel
Phase 1b/2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of Gemcitabine
Phase 1b/2: PK: Cmax of Docetaxel
+14 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 2: Olaratumab + Gemcitabine + DocetaxelExperimental Treatment3 Interventions
Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Group II: Phase 1b: Cohort 2 overall - 20 mg/kg Olaratumab + Gemcitabine + DocetaxelExperimental Treatment3 Interventions
Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met (cohort 2). Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2 (cohort 2 expansion).
Group III: Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + DocetaxelExperimental Treatment3 Interventions
Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Group IV: Phase 2: Placebo + Gemcitabine + DocetaxelPlacebo Group3 Interventions
Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaratumab
2010
Completed Phase 3
~1810
Gemcitabine
2017
Completed Phase 3
~1920
Docetaxel
1995
Completed Phase 4
~6550

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,662 Previous Clinical Trials
3,226,814 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,382 Previous Clinical Trials
424,996 Total Patients Enrolled
~32 spots leftby Oct 2025
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