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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 (excluding Kaposi's sarcoma and gastrointestinal stromal tumors)
Performance status 0-1 on the ECOG scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization (cycle 1) through follow-up (up to 35.8 months)
Awards & highlights
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 belowSelect...
My sarcoma cannot be removed by surgery or cured with radiation, and it's not Kaposi's sarcoma or a gastrointestinal stromal tumor.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have never been treated with anthracyclines.
Select...
My tumor tissue is available for testing.
ANNOUNCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomization (cycle 1) through follow-up (up to 35.8 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization (cycle 1) through follow-up (up to 35.8 months)
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 moreANNOUNCE 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
2,613 Previous Clinical Trials
3,200,420 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,743 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my brain or its coverings.My sarcoma cannot be removed by surgery or cured with radiation, and it's not Kaposi's sarcoma or a gastrointestinal stromal tumor.I am fully active or restricted in physically strenuous activity but can do light work.I have been diagnosed with GIST or Kaposi sarcoma.I have had radiotherapy on specific parts of my body.I do not have any active infections, including HIV or hepatitis.I have not had recent heart issues like unstable angina, angioplasty, stenting, or a heart attack.I have never been treated with anthracyclines.I finished my last cancer treatment more than 3 weeks ago.My tumor tissue is available for testing.My blood, organ function, and clotting tests are normal.I do not have severe heart problems like heart failure or irregular heartbeat.I have been treated with specific heart-related cancer drugs before.
Research Study Groups:
This trial has the following groups:- Group 1: Doxorubicin + Placebo
- Group 2: Doxorubicin + Olaratumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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