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Trabectedin for Soft Tissue Sarcoma

Sarcoma Oncology Research Center, Santa Monica, CA
Soft Tissue Sarcoma+1 More ConditionsTrabectedin - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is investigating if a combination of drugs can effectively treat NSCLC.

Eligible Conditions
  • Soft Tissue Sarcoma
  • Metastatic Soft Tissue Sarcoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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1
Metronomic dosing
1
Doxorubicin
1
Gemcitabine

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 30 months

24 months
Objective response rate (ORR), disease control rate (DCR)
Overall survival (OS), 6 month OS rate
Progression free survival (PFS), 6 month PFS rate
30 months
Dexamethasone and immune related events
Tumor response and PD-1, PD-L1 expression in tumors
6 months
Maximum tolerated dose

Trial Safety

Phase-Based Safety

1 of 3

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1
Metronomic dosing
1
Doxorubicin
1
Gemcitabine

Side Effects for

Trabectedin/DOXIL
77%Neutropenia
75%Nausea
56%Alanine Aminotransferase Increased
56%Vomiting
49%Leukopenia
48%Anaemia
46%Fatigue
42%Aspartate Aminotransferase Increased
35%Thrombocytopenia
33%Constipation
33%Anorexia
26%Palmar-Plantar Erythrodysaesthesia Syndrome
25%Diarrhoea
23%Blood Alkaline Phosphatase Increased
21%Abdominal Pain
20%Stomatitis
19%Pyrexia
17%Headache
17%Asthenia
16%Dyspnoea
15%Hyperbilirubinaemia
13%Dyspepsia
13%Mucosal Inflammation
13%Alopecia
12%Cough
11%Rash
11%Hypokalaemia
10%Dizziness
10%Insomnia
9%Oedema Peripheral
9%Back Pain
7%Anxiety
7%Blood Creatine Phosphokinase Increased
7%Hypoalbuminaemia
6%Abdominal Pain Upper
6%Arthralgia
6%Skin Hyperpigmentation
6%Pain in Extremity
6%Dysgeusia
6%Blood Creatinine Increased
6%Hyponatraemia
5%Pain
5%Abdominal Distension
5%Urinary Tract Infection
5%Myalgia
5%Febrile Neutropenia
5%Dry Skin
5%Pharyngolaryngeal Pain
5%Erythema
4%Ascites
4%Pulmonary Embolism
3%Mouth Ulceration
3%Pruritus
2%Pancytopenia
2%Intestinal Obstruction
2%Small Intestinal Obstruction
2%Dehydration
1%Syncope
1%Colonic Obstruction
1%Bone Marrow Failure
1%Cardiac Failure Congestive
1%Catheter Related Complication
1%General Physical Health Deterioration
1%Non-Cardiac Chest Pain
1%Catheter Related Infection
1%Catheter Site Infection
1%Hypersensitivity
1%Bacteraemia
1%Neutropenic Sepsis
1%Neutropenic Infection
1%Subclavian Vein Thrombosis
1%Pneumonia
1%Thrombosis
1%Renal Failure Acute
1%Pleural Effusion
1%Axillary Vein Thrombosis
This histogram enumerates side effects from a completed 2010 Phase 3 trial (NCT00113607) in the Trabectedin/DOXIL ARM group. Side effects include: Neutropenia with 77%, Nausea with 75%, Alanine Aminotransferase Increased with 56%, Vomiting with 56%, Leukopenia with 49%.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Phase 1
1 of 1

Experimental Treatment

45 Total Participants · 1 Treatment Group

Primary Treatment: Trabectedin · No Placebo Group · Phase 1 & 2

Phase 1Experimental Group · 3 Interventions: Nivolumab, Trabectedin, Ipilimumab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Trabectedin
FDA approved
Ipilimumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 months

Who is running the clinical trial?

Sarcoma Oncology Research Center, LLCLead Sponsor
7 Previous Clinical Trials
521 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,541 Previous Clinical Trials
4,019,551 Total Patients Enrolled
Erlinda M Gordon, MDPrincipal InvestigatorSarcoma Oncology Research Center
3 Previous Clinical Trials
94 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 3 months.
References

Frequently Asked Questions

Could you illustrate the research conducted on Trabectedin to date?

"Currently, there are 779 active studies being conducted on Trabectedin with 88 of them in the third phase. These clinical trials are largely centered around Pittsburgh, Pennsylvania but can be found at 42897 centres worldwide." - Anonymous Online Contributor

Unverified Answer

How extensive is the current participant pool for this experiment?

"Correct. According to clinicaltrials.gov, the experimental trial commencing on April 13th 2017 is currently recruiting participants and requires 45 people from a single location for completion." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies available within this research project?

"The data presented on clinicaltrials.gov indicates that this medical experiment is in its active recruitment phase, having initially been posted on April 13th 2017 and most recently updated on May 4th 2022." - Anonymous Online Contributor

Unverified Answer

What maladies is Trabectedin typically prescribed for?

"Trabectedin is typically used to treat inoperable melanoma, but it can also be prescribed for squamous cell carcinoma and a heightened risk of recurrence." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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