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Alkylating agents
Unesbulin for Leiomyosarcoma (SUNRISELMS Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by PTC Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 1 prior systemic cytotoxic or targeted therapy regimen for LMS, which may include but is not limited to single-agent doxorubicin or other anthracycline, doxorubicin plus ifosfamide, trabectedin, pazopanib, or gemcitabine with or without docetaxel
Histological or cytological confirmation of LMS arising at any anatomic site except bone sarcoma, unresectable or metastatic, relapsed or refractory disease measurable per RECIST 1.1 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization up to approximately 2 years
Awards & highlights
SUNRISELMS Trial 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.
Who is the study for?
This trial is for adults with advanced Leiomyosarcoma (LMS) who have tried at least one other treatment. They should not have had major surgery or certain cancer treatments in the last few weeks and must be mostly recovered from previous therapy side effects, except hair loss. People with well-controlled breathing issues or liver metastases can join, but those with recent serious injuries, certain past cancers, or conditions that could affect drug absorption cannot.Check my eligibility
What is being tested?
The study tests Unesbulin combined with Dacarbazine against a placebo plus Dacarbazine in patients whose LMS cannot be surgically removed or has spread and did not respond to prior treatments. The goal is to see if Unesbulin helps better than no active treatment when both are given alongside Dacarbazine.See study design
What are the potential side effects?
Possible side effects of Unesbulin and Dacarbazine may include fatigue, nausea, vomiting, low blood cell counts leading to increased infection risk and bleeding problems. There might also be liver issues and allergic reactions among others.
SUNRISELMS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least one treatment for LMS, including drugs like doxorubicin.
Select...
My cancer is a type called LMS, not in the bones, and can't be removed or has spread.
Select...
My cancer got worse on previous treatments or I couldn't tolerate them.
SUNRISELMS Trial 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%
Dysphagia
19%
Headache
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%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Hypoglycemia
8%
Dysphagia-esophageal radiation
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
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%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)
SUNRISELMS 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
Unesbulin
2019
Completed Phase 1
~50
Dacarbazine
2005
Completed Phase 3
~5110
Find a Location
Who is running the clinical trial?
PTC TherapeuticsLead Sponsor
74 Previous Clinical Trials
5,870 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
41 Patients Enrolled for Leiomyosarcoma
Mona Wahba, MD, MSMStudy DirectorPTC Therapeutics
Mark Rance, MDStudy DirectorPTC Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My asthma or COPD is well-managed.I haven't had cancer treatment or radiation in the last 3 weeks.My cancer has spread to my liver.I have recovered from major surgery or serious injury within the last 4 weeks.I have had at least one treatment for LMS, including drugs like doxorubicin.I have recovered from previous cancer treatments, except for hair loss.I have asthma or COPD, but it's well-managed.It's been over 4 weeks since my last surgery and I've recovered.I don't have stomach issues affecting drug absorption.I haven't had cancer, except for certain low-risk types, that needed treatment or came back in the last 5 years.I have not received a live vaccine in the last 30 days.I have recovered from previous cancer treatments, except for hair loss.My cancer is a type called LMS, not in the bones, and can't be removed or has spread.I am allergic to dacarbazine or an ingredient in unesbulin.I have taken temozolomide or dacarbazine before.My cancer got worse on previous treatments or I couldn't tolerate them.I have had at least one treatment for LMS before.I had surgery over 4 weeks ago and have recovered.
Research Study Groups:
This trial has the following groups:- Group 1: Unesbulin and Dacarbazine
- Group 2: Placebo and Dacarbazine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Leiomyosarcoma Patient Testimony for trial: Trial Name: NCT05269355 — Phase 2 & 3
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?
Met criteria
Did not meet 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.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Is there any hope?
PatientReceived 1 prior treatment
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