A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
Stemline Therapeutics, Inc.
Summary
This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer. The phase 1b part of the trial will determine the recommended Phase 2 dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.
Description
This is a multicenter, Phase 1b/2 trial. The Phase 1b aims at selecting the RP2D dose, defined as a dose that is associated with less than 33% of participants experiencing a dose-limiting toxicity (DLT) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, ribociclib, and capivasertib that is, ≤1 participant experiencing a DLT out of 6 DLT-evaluable participants. For each combination, this phase will have approximately 3 cohorts of up to 6 DLT-evaluable participants each. The total number of DLT-evaluable participants in all the combinations will be up to 125…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant has signed the informed consent before all study specific activities are conducted. 2. Women or men aged ≥18 years (or the minimum age of consent in accordance with the local law), at the time of informed consent signature. Female participants may be of any menopausal status. * Postmenopausal status is defined as follows or in accordance with local regulations: 1. Age ≥60 years or 2. Age \<60 years and amenorrhea for 12 or more months (without an alternative cause) and follicle-stimulating hormone value and an estradiol level within the postme…
Interventions
- DrugElacestrant
Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days
- DrugAlpelisib
Alpelisib 150 mg or 250 mg once daily in cycles of 28 days
- DrugEverolimus
Everolimus 5 mg, 7.5 mg, or 10 mg once daily in cycles of 28 days
- DrugRibociclib
Ribociclib 400 mg or 600 mg once daily for 21 days followed by 7 days off in cycles of 28 days
- DrugPalbociclib
Palbociclib 100 mg or 125 mg once daily for 21 days followed by 7 days off in cycles of 28 days
- DrugCapivasertib
Capivasertib 200 mg or 320 mg or 400 mg twice daily for 4 days on, 3 days off in cycles of 28 days
- Drug
Locations (118)
- Dothan Hematology and OncologyDothan, Alabama
- Mayo Clinic - ArizonaPhoenix, Arizona
- Highlands Oncology GroupSpringdale, Arkansas
- OPN Healthcare (Arcadia Location)Arcadia, California
- City of Hope National Medical CenterDuarte, California
- Glendale AdventistGlendale, California