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Anti-tumor antibiotic

Doxorubicin + Olaratumab for Soft Tissue Sarcoma (ANNOUNCE Trial)

Phase 3
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
Histologically confirmed diagnosis of advanced unresectable or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy. Participants with Kaposi's sarcoma and gastrointestinal stromal tumors (GIST) will be excluded. Note: Evidence of disease progression is required for participants that are not newly diagnosed.
Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization (cycle 1) through follow-up (up to 35.8 months)
Awards & highlights
Pivotal Trial

ANNOUNCE Trial Summary

This trial is testing if adding olaratumab to doxorubicin helps people with advanced soft tissue sarcoma more than just using doxorubicin alone.

Who is the study for?
This trial is for adults with advanced or metastatic soft tissue sarcoma that can't be removed by surgery or treated with radiotherapy. Excluded are those with Kaposi's sarcoma, GIST, heart problems, QTcB interval issues on ECGs, pregnant/breastfeeding women, active infections including HIV/hepatitis, brain metastasis unless treated and stable for 60 days without steroids/anticonvulsants. Participants must not have had prior anthracycline therapy or olaratumab.Check my eligibility
What is being tested?
The study tests the effectiveness of combining doxorubicin (a chemotherapy drug) with either olaratumab (an investigational drug) or a placebo in patients. The goal is to see if adding olaratumab improves outcomes compared to just doxorubicin alone.See study design
What are the potential side effects?
Doxorubicin may cause side effects like hair loss, nausea/vomiting, mouth sores, and increased risk of infection due to low blood cell counts. Olaratumab could potentially cause infusion reactions such as fever/chills and allergic responses.

ANNOUNCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced soft tissue sarcoma that cannot be cured with surgery or radiotherapy, and I do not have Kaposi's sarcoma or GIST.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have never been treated with anthracyclines.
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I've had treatments for advanced cancer and can receive anthracycline therapy, with my last cancer treatment over 3 weeks ago.
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I can provide a sample of my tumor for the study.
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My blood, organ function, and clotting tests are normal.
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I am a woman who can have children and I have a negative pregnancy test from the last week.
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I agree to use effective birth control during and up to 3 months after the trial.

ANNOUNCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization (cycle 1) through follow-up (up to 35.8 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization (cycle 1) through follow-up (up to 35.8 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Overall Survival (OS) Leiomyosarcoma (LMS)
Secondary outcome measures
Change From Baseline to Maximum Improvement in Health Status Index Score on the EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Duration of Disease Control (DDC)
Duration of Overall Response (DoR)
+7 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

ANNOUNCE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Doxorubicin + OlaratumabExperimental Treatment2 Interventions
75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21-day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21-day cycle until documented progressive disease (PD) or discontinuation for any other reason.
Group II: Doxorubicin + PlaceboPlacebo Group2 Interventions
75 mg/m^2 doxorubicin administered IV on day 1 of each 21-day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21-day cycle until PD or discontinuation for any other reason.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaratumab
2010
Completed Phase 2
~1300
Doxorubicin
2012
Completed Phase 3
~7940

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,594 Previous Clinical Trials
3,184,298 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,330 Previous Clinical Trials
401,037 Total Patients Enrolled

Media Library

Doxorubicin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT02451943 — Phase 3
Soft Tissue Sarcoma Research Study Groups: Doxorubicin + Placebo, Doxorubicin + Olaratumab
Soft Tissue Sarcoma Clinical Trial 2023: Doxorubicin Highlights & Side Effects. Trial Name: NCT02451943 — Phase 3
Doxorubicin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02451943 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please let me know what the risks are for patients who take Olaratumab?

"Olaratumab has demonstrated efficacy in Phase 3 trials and has been shown to be safe in multiple rounds of testing, so our team at Power estimates its safety to be a 3."

Answered by AI

For what medical purpose is Olaratumab most often given to patients?

"Olaratumab is frequently used to treat hodgkins and lymphoma. However, it can also ameliorate bronchogenic carcinoma, neuroblastoma (nb), sezary syndrome, and other conditions."

Answered by AI

Does this trial offer anything new in terms of treatments?

"Alfacell's 1997 Olaratumab study, which completed Phase 3 drug approval in 300 participants, is the earliest on record. 381 active trials are currently taking place across 67 countries and 1932 cities. A total of 18951 studies have been completed since Alfacell's initial research."

Answered by AI

Are there any other existing trials that use Olaratumab?

"At the moment, there are 381 ongoing clinical trials researching Olaratumab. Out of these medical studies, 119 have reached Phase 3. Of the23380 locations conducting these trials, many are based in New york City."

Answered by AI
Recent research and studies
~54 spots leftby Feb 2025