All > Orlando > Leiomyosarcoma

Unesbulin for Leiomyosarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
LeiomyosarcomaUnesbulin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare two different treatments for leiomyosarcoma, a type of cancer. One treatment will be the standard of care, and the other will be a new treatment that includes a drug called unesbulin. The trial will look at whether the new treatment is more effective and has fewer side effects than the standard treatment.

Video Summary

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Radiotherapy
1
Radiotherapy
1
Vinblastine

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: From the date of randomization up to approximately 2 years

Year 2
Overall Survival
Year 2
Progression-free Survival per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Assessed by an Independent Central Imaging Laboratory
Year 2
Objective Response Rate (ORR)
Year 2
Disease Control Rate (DCR)
Year 2
Number of Participants with Treatment-emergent Adverse Events
Year 2
Duration of Response per RECIST 1.1 Assessed by an Independent Central Imaging Laboratory

Trial Safety

Safety Progress

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

Similar Trials

1
Radiotherapy
1
Radiotherapy
2
Vinblastine

Side Effects for

Arm B (Stanford V)
98%Anemia
93%Leukocytes decreased
90%Lymphopenia
84%Neutrophils decreased
78%Neuropathy-sensory
75%Alopecia
74%Fatigue
67%Nausea
60%Hyperglycemia
52%Constipation
46%Hypoalbuminemia
40%Myalgia
34%Stomatitis
33%Insomnia
32%Vomiting
27%Platelets decreased
26%Alkaline phosphatase increased
26%Aspartate aminotransferase increased
23%Dyspnea
20%Dyspepsia
19%Dysphagia
19%Headache
16%Arthralgia
16%Anorexia
15%Abdominal pain
15%Neuropathy-motor
14%Cough
14%Fever
14%Infection w/o neutropenia
13%Diarrhea w/o prior colostomy
13%Rash/desquamation
12%Bone pain
11%Weight gain
11%Taste disturbance
11%Anxiety/agitation
10%Sweating
10%Radiation dermatitis
9%Dizziness/lightheadedness
9%Rigors/chills
9%Injection site reaction
8%Pain-other
8%Phlebitis
8%Chest pain
8%Blood bilirubin increased
8%Dysphagia-esophageal radiation
8%Hypoglycemia
7%Pruritus
7%Edema
7%Creatinine increased
6%Infection w/ grade 3 or 4 neutropenia
6%Hot flashes
6%Weight loss
5%Mouth dryness
5%Depression
5%Muscle weakness
4%Pneumonitis/pulmonary infiltrates
4%Transfusion: pRBCs
3%Irregular menses
3%Febrile neutropenia
3%Nail changes
3%Thrombosis/embolism
2%Allergic rhinitis
1%Syncope
1%Sinus tachycardia
1%Infection w/ unknown ANC
1%Neuropathic pain
1%Allergic reaction
1%Dehydration
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT00003389) in the Arm B (Stanford V) ARM group. Side effects include: Anemia with 98%, Leukocytes decreased with 93%, Lymphopenia with 90%, Neutrophils decreased with 84%, Neuropathy-sensory with 78%.

Trial Design

2 Treatment Groups

Unesbulin and Dacarbazine
1 of 2
Placebo and Dacarbazine
1 of 2

Experimental Treatment

Non-Treatment Group

345 Total Participants · 2 Treatment Groups

Primary Treatment: Unesbulin · Has Placebo Group · Phase 2 & 3

Unesbulin and DacarbazineExperimental Group · 2 Interventions: Unesbulin, Dacarbazine · Intervention Types: Drug, Drug
Placebo and DacarbazinePlaceboComparator Group · 2 Interventions: Dacarbazine, Placebo · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dacarbazine
2005
Completed Phase 3
~5630

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from the date of randomization up to approximately 2 years

Who is running the clinical trial?

PTC TherapeuticsLead Sponsor
70 Previous Clinical Trials
5,704 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
41 Patients Enrolled for Leiomyosarcoma
Mona Wahba, MD, MSMStudy DirectorPTC Therapeutics
Mark Rance, MDStudy DirectorPTC Therapeutics

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants with well-controlled asthma or chronic obstructive pulmonary disease may be enrolled.
At least 4 weeks since prior surgery and recovered in the opinion of investigator Key.
You have disease progression on previous treatment before screening or intolerability to other oncology treatments.
You have a solid tumor of any histological or cytological type, measurable per RECIST 1.1 criteria, and are aged 18 years or older.
References

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top