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

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

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.