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Trabectedin for Leiomyosarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
LeiomyosarcomaTrabectedin - Drug
Eligibility
18+
All Sexes
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Select

Study Summary

This trial is testing a new combination of drugs to treat cancer. The drugs are given at lower doses than usual, and more often.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
VAL-413
1
Irinotecan
1
Arm 1 (olaparib, temozolomide)

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 12 months

12 months
Adverse Event
Progression free survival
6 weeks
Overall Response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
VAL-413
1
Irinotecan
2
Arm 1 (olaparib, temozolomide)

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%Hypokalaemia
11%Rash
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%.

Trial Design

1 Treatment Group

Single arm
1 of 1

Experimental Treatment

80 Total Participants · 1 Treatment Group

Primary Treatment: Trabectedin · No Placebo Group · Phase 2

Single arm
Drug
Experimental Group · 1 Intervention: Trabectedin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Sarcoma Oncology Research Center, LLCLead Sponsor
6 Previous Clinical Trials
466 Total Patients Enrolled
Sant P Chawla, MDPrincipal InvestigatorSarcoma Oncology Research Center, LLC
6 Previous Clinical Trials
422 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Creatinine levels that are below 1.5 times the upper limit of normal and a creatinine clearance that is greater than 60 ml/min using the Crockroft-Gault formula indicate acceptable renal function.
The person understands the purpose and risks of the study and has signed and dated a written informed consent form approved by the Investigator's IRB/Ethics Committee.
The acceptable liver function is when the bilirubin level is less than 1.5 times the upper limit of normal
acceptable hematologic status: anc (absolute neutrophil count) greater than or equal to 1000 cells per microliter; platelet count greater than or equal to 100,000 per microliter; hemoglobin greater than or equal to 9.
In cases where the individual is taking anti-coagulants, their PT, INR, and aPTT values must all be within the therapeutic range for the intended use of the anticoagulant medication
If you are a male or female aged 18 years or older, you are eligible to participate in this study.
A cancer that begins in the muscles called leiomyosarcoma is advanced if it has spread from where it began to other parts of the body
A patient who has been treated before and who still has measurable disease according to the RECIST v1.1 standard.
The patient has an ECOG performance status of ≤ 2, which means that they are in fair or poor condition.
The patient will have a life expectancy of at least 3 months.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

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