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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
Must not have
Gastrointestinal disease or other conditions that could affect absorption. Active peptic ulcer disease, active gastritis, or previous history of gastric perforation within the last 2 years
Immunization with a live vaccine within 30 days before starting study drug due to the risk of serious and life-threatening infections
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization until the date of objectively documented progression or the date of initiation of subsequent therapy or palliative local therapy, whichever occurs first (up to approximately 2 years)
Awards & highlights

Summary

This trial tests a new drug combination of unesbulin and dacarbazine in patients with advanced LMS who have not responded to previous treatments. The goal is to see if unesbulin can help stop cancer growth and make dacarbazine more effective. Dacarbazine is an anticancer drug that has been used to treat various types of cancers.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had at least one treatment for LMS, including drugs like doxorubicin.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have stomach issues affecting drug absorption.
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I have not received a live vaccine in the last 30 days.
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I am allergic to dacarbazine or an ingredient in unesbulin.
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I have taken temozolomide or dacarbazine before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of randomization until the date of objectively documented progression or the date of initiation of subsequent therapy or palliative local therapy, whichever occurs first (up to approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization until the date of objectively documented progression or the date of initiation of subsequent therapy or palliative local therapy, whichever occurs first (up to approximately 2 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Disease Control Rate (DCR)
Objective Response Rate (ORR)

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
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%
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%
Dysphagia-esophageal radiation
8%
Hypoglycemia
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)

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
2017
Completed Phase 1
~70
Dacarbazine
2005
Completed Phase 3
~5350

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Leiomyosarcoma (LMS) treatments often target cellular pathways critical for tumor growth and survival. Unesbulin, currently under study, is believed to exert anti-tumor effects by inhibiting specific cellular pathways, potentially disrupting cancer cell proliferation. Dacarbazine, a chemotherapy agent, works by alkylating DNA, leading to cell death. Eribulin, another treatment option, inhibits microtubule dynamics, which is essential for cell division, thereby causing cancer cell death. Paclitaxel also targets microtubules but stabilizes them, preventing cell division and leading to cell death. Understanding these mechanisms is crucial for LMS patients as it helps in selecting the most effective treatment based on the tumor's specific characteristics and resistance patterns.
Combined antimicrotubule activity of estramustine and taxol in human prostatic carcinoma cell lines.Mass Spectrometry-Based Method to Study Inhibitor-Induced Metabolic Redirection in the Central Metabolism of Cancer Cells.Combination of two anti-tubulin agents, eribulin and paclitaxel, enhances anti-tumor effects on triple-negative breast cancer through mesenchymal-epithelial transition.

Find a Location

Who is running the clinical trial?

PTC TherapeuticsLead Sponsor
74 Previous Clinical Trials
5,878 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
41 Patients Enrolled for Leiomyosarcoma
Mark Rance, MDStudy DirectorPTC Therapeutics
Mona Wahba, MD, MSMStudy DirectorPTC Therapeutics

Media Library

Dacarbazine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05269355 — Phase 2 & 3
Leiomyosarcoma Research Study Groups: Unesbulin and Dacarbazine, Placebo and Dacarbazine
Leiomyosarcoma Clinical Trial 2023: Dacarbazine Highlights & Side Effects. Trial Name: NCT05269355 — Phase 2 & 3
Dacarbazine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05269355 — Phase 2 & 3
Leiomyosarcoma Patient Testimony for trial: Trial Name: NCT05269355 — Phase 2 & 3
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