Trial purpose
Cancer treatment
Tumor type
Sarcoma
Age
18+
Clinical summary
Summary
Eligible participants will be randomly allocated to either the Experimental Arm or Placebo Comparator Arm. In the Experimental Arm, participants will receive unesbulin (300mg) tablets administered orally, twice weekly, in each 3-week treatment cycle, in combination with dacarbazine (1000mg/m^2) given intravenously once every 21 days. In the Placebo Comparator Arm, participants will receive placebo tablets administered orally twice weekly in each 3-week treatment cycle, in combination with dacarbazine (1000mg/m^2) administered intravenously once every 21 days.
Conditions
This trial is treating people with leiomyosarcoma
Eligibility
Inclusion
- 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
- Disease progression on previous treatment before screening or intolerability to other oncology treatments
- Participants with liver metastases may be enrolled
- Participants with well-controlled asthma or chronic obstructive pulmonary disease may be enrolled.
- Toxicity from prior therapies recovered to Grade ≤1 or participant's baseline, except for alopecia. In addition, endocrinopathies associated with prior immunotherapy-based treatments that are well controlled on replacement medication are not exclusionary.
- 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.
- At least 4 weeks since prior surgery and recovered in the opinion of investigator
Exclusion
- Received temozolomide or dacarbazine at any time
- Any other systemic anticancer therapy including investigational agents ≤3 weeks before initiation of study treatment. Additionally, participants may not have received radiation ≤3 weeks before initiation of study treatment.
- Known intolerance to dacarbazine or one or more of the excipients in unesbulin.
- Co-existing active infection or any co-existing medical condition likely to interfere with study procedures
- 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
- Major surgery, open biopsy, or significant traumatic injury that has not recovered, in the opinion of the investigator, within 28 days of baseline
- Immunization with a live vaccine within 30 days before starting study drug due to the risk of serious and life-threatening infections.
- Prior malignancies, other than LMS, that required treatment or have shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ, prostate cancer in situ or any other low risk malignancy that is approved by the medical monitor) during the 5 years before initiation.
- Prior or ongoing clinically significant illness, medical or psychiatric condition, medical history, physical findings, electrocardiogram (ECG) findings, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant, or alter the absorption, distribution, metabolism, or excretion of the study drugs, or could impair the assessment of study results.
Note: Other inclusion and exclusion criteria may apply.
Inclusion
- You are able to swallow medication by mouth.
- You have had a certain type of treatment or surgical procedure.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has not spread to other parts of the body (localised).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
PTC Therapeutics
Scientific Title
A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information