Alkylating agents
Unesbulin for Leiomyosarcoma
Sarcoma Oncology Research Center, Santa Monica, CA
Unesbulin +2 morePhase 2 & 3RecruitingResearch Sponsored by PTC TherapeuticsEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with liver metastases may be enrolled
Participants with well-controlled asthma or chronic obstructive pulmonary disease may be enrolled.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfrom the date of randomization up to approximately 2 years
Awards & highlights
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.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You can still participate if the cancer has spread to your liver.
Select...
You can join the study even if you have asthma or chronic obstructive pulmonary disease, as long as your condition is well-managed.
Select...
You have already received at least one type of medicine to treat your LMS cancer.
Select...
Your disease has gotten worse while on previous treatment or you have had serious side effects from other cancer treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of randomization up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of randomization up to approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Assessed by an Independent Central Imaging Laboratory
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response per RECIST 1.1 Assessed by an Independent Central Imaging Laboratory
Number of Participants with Treatment-emergent Adverse Events
+2 moreSide effects data
From 2016 Phase 3 trial • 854 Patients • NCT0000338998%
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%
Headache
19%
Dysphagia
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
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%
Hypoglycemia
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
8%
Dysphagia-esophageal radiation
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
1%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Unesbulin and DacarbazineExperimental Treatment2 Interventions
Participants will receive unesbulin 300 milligrams (mg) tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/meter squared (m^2) intravenously (IV) once every 21 days. Treatment will continue for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
Group II: Placebo and DacarbazinePlacebo Group2 Interventions
Participants will receive placebo matching to unesbulin tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m^2 IV once every 21 days. Treatment will continue for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dacarbazine
2005
Completed Phase 3
~5630
Find a site
Who is running the clinical trial?
PTC TherapeuticsLead Sponsor
72 Previous Clinical Trials
5,745 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
41 Patients Enrolled for Leiomyosarcoma
Mona Wahba, MD, MSMStudy Director
PTC TherapeuticsMark Rance, MDStudy Director
PTC TherapeuticsMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently enrolling people into this trial?
"The clinical trial mentioned is still searching for participants and was first posted on May 23rd, 2022. The last update to the trial was on September 21st, 2022."
Answered by AI
How many research facilities are managing this clinical trial?
"Patients can enroll at various hospitals and research centres, some of which include The Trustees of Columbia University in New York, New York, University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania, and Washington University in Saint Louis, Missouri."
Answered by AI
How many individuals are receiving care in this clinical trial?
"The sponsor, PTC Therapeutics, needs to enroll 345 patients that meet the basic requirements for the trial. The trial will take place in New York, New York at The Trustees of Columbia University and University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
What site did they apply to?
Sarcoma Oncology Research Center
The Trustees of Columbia University
Why did patients apply to this trial?
I have leiomyosarcoma for the second time. I received 35 round of radiation. After surgery on March 18. the cancer seemed to be gone. The radiation damaged my leg severely and the cancer came back. Along with breast cancer.
Patient
What questions have other patients asked about this trial?
Is there any hope?
Patient