A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS) (SUNRISELMS)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05269355 |
|
Recruitment Status :
Recruiting
First Posted : March 8, 2022
Last Update Posted : May 26, 2023
|
Sponsor:
PTC Therapeutics
Information provided by (Responsible Party):
PTC Therapeutics
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
This study will compare the efficacy and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory LMS who have received at least 1 prior line of systemic therapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leiomyosarcoma | Drug: Unesbulin Drug: Dacarbazine Other: Placebo | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 345 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma |
| Actual Study Start Date : | May 23, 2022 |
| Estimated Primary Completion Date : | June 30, 2024 |
| Estimated Study Completion Date : | June 30, 2024 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Dacarbazine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Unesbulin and Dacarbazine
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.
|
Drug: Unesbulin
Unesbulin will be administered as per the dose and schedule specified in the arm description.
Other Name: PTC596 Drug: Dacarbazine Dacarbazine will be administered as per the dose and schedule specified in the arm description.
Other Name: DTIC |
|
Placebo Comparator: Placebo and Dacarbazine
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.
|
Drug: Dacarbazine
Dacarbazine will be administered as per the dose and schedule specified in the arm description.
Other Name: DTIC Other: Placebo Placebo will be administered as per the schedule specified in the arm description. |
Primary Outcome Measures :
- Progression-free Survival per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Assessed by an Independent Central Imaging Laboratory [ Time Frame: From the date of randomization to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 2 years) ]
Secondary Outcome Measures :
- Overall Survival [ Time Frame: From the date of randomization to the date of death due to any cause (up to approximately 2 years) ]
- Objective Response Rate (ORR) [ Time Frame: 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) ]ORR is defined as the number of participants who achieve a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using RECIST 1.1 as per independent radiologist assessment.
- Disease Control Rate (DCR) [ Time Frame: From the date of randomization until the date of the first documented tumor progression or the date of initiation of subsequent therapy or palliative local therapy, whichever occurs first (up to approximately 2 years) ]DCR is defined as the number of participants with BOR of CR, PR, or stable disease (≥3 months) using RECIST 1.1 as per independent radiologist assessment.
- Duration of Response per RECIST 1.1 Assessed by an Independent Central Imaging Laboratory [ Time Frame: Time from the date of first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 2 years) ]
- Number of Participants with Treatment-emergent Adverse Events [ Time Frame: From the date of randomization up to approximately 2 years ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- 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
- At least 4 weeks since prior surgery and recovered in the opinion of investigator
Key Exclusion Criteria:
- 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 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
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05269355
Contacts
| Contact: Patient Advocacy | 1-866-562-4620 | medinfo@ptcbio.com |
Locations
Show 37 study locations
Sponsors and Collaborators
PTC Therapeutics
Investigators
| Study Director: | Mark Rance, MD | PTC Therapeutics |
| Responsible Party: | PTC Therapeutics |
| ClinicalTrials.gov Identifier: | NCT05269355 |
| Other Study ID Numbers: |
PTC596-ONC-008-LMS |
| First Posted: | March 8, 2022 Key Record Dates |
| Last Update Posted: | May 26, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Leiomyosarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma |
Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |