A Phase 1 interventional study of RAD140 in Hormone Receptor Positive Malignant Neoplasm of Breast, sponsored by Stemline Therapeutics, Inc.. Completed at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-18.
Sponsored by Stemline Therapeutics, Inc. · Phase 1, Interventional, and Treatment
The primary purpose of this study is to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.
This is a first in humans study that is designed to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Stemline Therapeutics, Inc. is the lead sponsor of 22 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Part A, Dose Escalation: Patients will be assigned sequentially to escalating doses of RAD140. Part B, Safety Expansion: Once the maximum tolerated dose (MTD) has been identified and/or a recommended dose escalation (RDE) has been determined, additional patients will be enrolled to further evaluate the safety, tolerability and preliminary clinical activity of the recommended dose.
Drug: RAD140
RAD140 will be supplied as formulated drug-in-capsules for oral administration.
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
Time frame: First 28 days of treatment
Number of adverse events related to study treatment
Number of adverse events related to study treatment
Time frame: Up to 30 days after end of treatment
Number participants with dose interruptions and dose adjustments
Number participants with dose interruptions and dose adjustments
Time frame: Up to 30 days after end of treatment
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax)
Time frame: Day 1 and 15
Time to maximum plasma concentration (Tmax)
Time to maximum plasma concentration (Tmax)
Time frame: Day 1 and 15
Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 1 and Day 15
Tumor response
Clinical benefit rate (CBR) or objective response rate (ORR) will be assessed by Investigators per RECIST v1.1 along with time-related efficacy endpoints.
Time frame: Screening and every 8 weeks for up to 12 months of treatment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Stemline Therapeutics, Inc.