What side effects are associated with this type of intervention?

Common treatments for Leiomyosarcoma (LMS) include chemotherapeutic agents such as dacarbazine, paclitaxel, and eribulin. Dacarbazine is known to cause side effects like nausea, vomiting, and myelosuppression. Paclitaxel, another common agent, often induces peripheral neuropathy, myelosuppression, and fatigue. Eribulin, while also causing peripheral neuropathy, tends to have a lower incidence and severity of this side effect compared to paclitaxel. Other side effects of eribulin include neutropenia and fatigue. These side effects are important considerations when evaluating treatment options for LMS.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Leiomyosarcoma (LMS). Dacarbazine, which is being used in combination with Unesbulin in the current study, is one such drug. Another notable drug is Pazopanib, a tyrosine kinase inhibitor that targets multiple pathways involved in tumor growth and angiogenesis. Additionally, Eribulin has been approved for use in patients with advanced LMS, demonstrating efficacy in clinical trials. These treatments focus on inhibiting specific cellular pathways to exert anti-tumor effects, similar to the investigational approach of Unesbulin.

What other types of research exist?

Promising novel alternatives to Unesbulin for Leiomyosarcoma patients include Eribulin mesylate, which has shown antitumor activity in refractory cancers, and Pazopanib, a multikinase angiogenesis inhibitor that has demonstrated efficacy in advanced soft tissue sarcomas. Both drugs offer different mechanisms of action that could be beneficial for LMS patients.

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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.

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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 weeks3 visits

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)

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

Rigors/chills

Dizziness/lightheadedness

Injection site reaction

Dysphagia-esophageal radiation

Hypoglycemia

Blood bilirubin increased

Chest pain

Pain-other

Phlebitis

Creatinine increased

Edema

Pruritus

Hot flashes

Infection w/ grade 3 or 4 neutropenia

Weight loss

Muscle weakness

Depression

Mouth dryness

Transfusion: pRBCs

Pneumonitis/pulmonary infiltrates

Thrombosis/embolism

Febrile neutropenia

Irregular menses

Nail changes

Allergic rhinitis

Allergic reaction

Infection w/ unknown ANC

Syncope

Sinus tachycardia

Dehydration

Neuropathic pain

100%

80%

60%

40%

20%

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

0 / 7Eligibility criteria met

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.