A Study of Unesbulin (PTC596) in Combination With Dacarbazine in Participants With Advanced Leiom… (NCT03761095) | Clinical Trial Compass
CompletedPhase 1
A Study of Unesbulin (PTC596) in Combination With Dacarbazine in Participants With Advanced Leiomyosarcoma (LMS)
United States41 participantsStarted 2019-03-13
Plain-language summary
The primary objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of unesbulin in combination with dacarbazine for the treatment of advanced LMS and determine the overall safety profile of unesbulin in combination with dacarbazine.
This study will employ the time-to-event continual reassessment method (TITE-CRM) for dose finding. Treatment will be initiated at dose level 2 (DL2) (Dacarbazine 1000 milligrams per square meter \[mg/m\^2\] intravenously \[IV\] every 21 days in combination with unesbulin 200 milligrams \[mg\] orally twice weekly) for the first participant. This dose level represents the investigator's best assessment of the MTD based on available toxicity data for both agents. For subsequent participants, the dose level at which treatment is initiated will be selected based on the TITE-CRM using the most up to date dose-limiting toxicity (DLT) information from all participants previously treated. To enroll additional participants at the RP2D, the study is amended to include an expansion cohort of up to 12 participants (some of whom could be ongoing participants who reconsent).
Treatment will continue for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Signed consent of an Institutional Review Board (IRB)-approved informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information (if appropriate).
✓. Willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
✓. Disease Status including all of the following:
✓. Histological or cytological confirmation of LMS arising at any anatomic site.
✓. Advanced (metastatic) or locally advanced unresectable disease.
✓. Ineligible for other high-priority national or institutional study.
✓. Measurable disease per RECIST v1.1 criteria.
✓. Age greater than or equal to (\>/=) 18
Exclusion criteria
✕6. Chemotherapy:
What they're measuring
1
MTD and RP2D of Unesbulin in Combination With Dacarbazine
Timeframe: First 2 cycles of treatment (6 weeks)
2
Number of Participants With Adverse Events
Timeframe: From screening until end of study (up to approximately 1.5 years)
7. At least 4 weeks since prior surgery and recovered in opinion of investigator.
✕8. Capable of swallowing oral medication.
✕9. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
✕0. Males and females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 90 days after treatment discontinuation. Note: The Definition of effective contraception will be based on the judgement of the Principal Investigator (PI) or Designee.
✕. Received any systemic anticancer therapy including investigational agents \<=3 weeks prior to initiation of study treatment. Additionally, Participants may have not received radiation \</= 3 weeks prior to initiation of study treatment.
✕. Co-existing active infection or any co-existing medical condition likely to interfere with study procedures, including:
✕. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) positivity.