Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer (OASIS)
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|ClinicalTrials.gov Identifier: NCT04720664|
Recruitment Status : Not yet recruiting
First Posted : January 22, 2021
Last Update Posted : May 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic Breast Cancer Hormone Receptor Positive Breast Carcinoma||Drug: SM-88||Phase 2|
This is a multicenter phase II single arm trial designed to evaluate the efficacy of SM-88 plus three subtherapeutic conditioning agents (methoxsalen, phenytoin, and sirolimus [MPS]) in patients with metastatic HR+/HER2- breast cancer. .
Thirty patients will be enrolled in first stage of the study, and if 3 or more patients have an objective response (complete or partial response) then an additional 20 patients will be enrolled in the second stage of the study. Patients will receive the recommended phase 2 dose (RP2D) of SM-88 (460 mg by mouth [PO] twice a day [BID] D1 - 28) as well as three conditioning agents (MPS): methoxsalen (10 mg PO daily [Qd] D1 - 28), phenytoin (50 mg PO Qd D1 - 28), and sirolimus (0.5 mg PO Qd D1 - 28).
Assessment of efficacy will be conducted every 3 cycles (approximately every 12 weeks) with CT chest/abdomen/pelvis using RECIST v1.1 criteria. Safety including clinic visits, and exams will occur every 4 weeks on Day 1 of each cycle. Laboratory testing will be performed every 2 weeks for the first 2 cycles and then on Day 1 of each subsequent cycle.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||OASIS: Phase II Trial of OrAl SM-88 in Patients With Metastatic Hormone Receptor-posItive HER2-negative (HR+/HER2-) breaSt Cancer|
|Estimated Study Start Date :||June 2021|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||May 2025|
Experimental: oral SM-88
SM-88 taken with three conditioning agents: methoxsalen, phenytoin, and sirolimus
- Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]Anti-tumor efficacy will be defined as partial response (PR) or complete response (CR) based on RECIST v1.1.
- Duration of Response (DOR) [ Time Frame: Up to 2 years ]
- Progression Free Survival (PFS) [ Time Frame: Up to 2 years ]Defined as the time in days from study entry to the first documented disease progression per RECIST v1.1 as assessed by local site or death. Patients who are alive and free from progression on the date of closing follow-up will be censored on that date.
- Clinical Benefit Rate (CBR) at ≥ 24 weeks [ Time Frame: Up to 2 years ]The percentage of patients who have complete response (CR), partial response (PR), o r stable disease (SD) at ≥ 24 weeks will be reported.
- Incidence of Treatment-Related Adverse Events [Safety and Tolerability] [ Time Frame: Day 1 of each cycle (28 day cycle); up to 2 years ]The number of participants with treatment-related adverse events as assessed by CTCAE v5.0
- Changes in cell free DNA (cfDNA) [ Time Frame: At baseline, prior to cycle 4 (each cycle is 28 days), and at disease progression (up to 2 years). ]Evaluation of changes in cell free DNA (cfDNA) at baseline, during treatment, and at disease progression.
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): NCT04720664
|United States, District of Columbia|
|MedStar Georgetown University Hospital, Lombardi Comprehensive Cancer Center|
|Washington, District of Columbia, United States, 20007|
|Contact: Julie Castle 202-687-2209 firstname.lastname@example.org|
|Principal Investigator: Julie Collins, MD|
|MedStar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|United States, Maryland|
|MedStar Franklin Square Medical Center|
|Baltimore, Maryland, United States, 21237|
|MedStar Good Samaritan Hospital|
|Baltimore, Maryland, United States, 21239|
|Principal Investigator:||Julie Collins, MD MPH||Georgetown University|