Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer (ELEVATE)

• ClinicalTrials.gov Identifier: NCT05563220
• Recruitment Status: Recruiting
• First Posted: October 3, 2022
• Last Update Posted: April 8, 2024
• Sponsor: Stemline Therapeutics, Inc.
• Information provided by (Responsible Party): Stemline Therapeutics, Inc.

Study Description

Brief Summary:

This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Metastatic Breast Cancer	Drug: Elacestrant; Drug: Alpelisib; Drug: Everolimus; Drug: Ribociclib; Drug: Palbociclib; Drug: Capivasertib; Drug: Abemaciclib	Phase 1; Phase 2

Detailed 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 patients experiencing a DLT of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib, that is, ≤1 patient experiencing a DLT out of 6 DLT evaluable patients. For each combination, this phase will have between 1 and 3 cohorts of 6 DLT-evaluable patients each. The total number of DLT-evaluable patients in all the combinations will vary between 24 and 72.

The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.

The treatment arms will be:

• Arm A: 50 patients: elacestrant with alpelisib;
• Arm B: 50 patients: elacestrant with everolimus;
• Arm C: 60 patients (30 patients in each combination): elacestrant with either abemaciclib or ribociclib;
• Arm D: 90 patients (30 patients in each combination): elacestrant with either palbociclib, abemaciclib, or ribociclib
• Arm E: 60 patients: elacestrant with capivasertib

Phase 1b will have a total of 90 patients, while Phase 2 will have 310 patients for all treatment arm combinations.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
• Actual Study Start Date: January 24, 2023
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: August 31, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Phase 1b Arm A: elacestrant with alpelisib; Elacestrant Dihydrochloride 300 mg or 400 mg + Alpelisib 250 mg or 300 mg	Drug: Elacestrant; Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days; Drug: Alpelisib; Alpelisib 250 mg or 300 mg once daily in cycles of 28 days; Other Name: Piqray
Experimental: Phase 1b Arm B: elacestrant with everolimus; Elacestrant Dihydrochloride 300 mg or 400 mg + Everolimus 5.0 mg, 7.5 mg or possibly 10 mg	Drug: Elacestrant; Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days; Drug: Everolimus; Everolimus 5 mg, 7.5 mg, or 10 mg once daily in cycles of 28 days; Other Name: Afinitor
Experimental: Phase 1b Arm C: elacestrant with abemaciclib or ribociclib: Elacestrant Dihydrochloride 100 mg, 200 mg, 300 mg + Ribociclib 400 mg or possibly 600 mg The recommended Phase 2 dose for the combination of elacestrant and abemaciclib is evaluated in the ongoing ELECTRA trial (ClinicalTrials.gov Identifier: NCT04791384)	Drug: Elacestrant; Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days; Drug: Ribociclib; Ribociclib 400 mg or 600 mg once daily for 21 days followed by 7 days off in cycles of 28 days; Other Name: Kisqali; Drug: Abemaciclib; Abemaciclib 100 mg or 150 mg twice daily in cycles of 28 consecutive days; Other Name: Verzenio
Experimental: Phase 1b Arm D: elacestrant with either palbociclib, abemaciclib, or ribociclib (no prior CDK4/6i); Elacestrant Dihydrochloride 300 mg or 400 mg + Palbociclib 100 mg,125 mg OR The recommended Phase 2 dose for the combination of elacestrant and abemaciclib is evaluated in the ongoing ELECTRA trial (ClinicalTrials.gov Identifier: NCT04791384) Elacestrant 86 mg, 172 mg, 258 mg + Ribociclib 400 mg or possibly 600 mg	Drug: Elacestrant; Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days; Drug: Ribociclib; Ribociclib 400 mg or 600 mg once daily for 21 days followed by 7 days off in cycles of 28 days; Other Name: Kisqali; Drug: Palbociclib; Palbociclib 100 mg or 125 mg once daily for 21 days followed by 7 days off in cycles of 28 days; Other Name: Ibrance; Drug: Abemaciclib; Abemaciclib 100 mg or 150 mg twice daily in cycles of 28 consecutive days; Other Name: Verzenio
Experimental: Phase 1b Arm E: Elacestrant Dihydrochloride 300 mg, 400 mg + Capivasertib 200 mg, 320 mg, 400 mg	Drug: Elacestrant; Elacestrant 86 mg, 172 mg, 258 mg or 345 mg once daily in cycles of 28 days; Drug: Capivasertib; Capivasertib 200 mg or 320 mg or 400 mg twice daily for 4 days on, 3 days off in cycles of 28 days; Other Name: Truqap

Outcome Measures

Primary Outcome Measures :

1. Number of DLTs observed during the first cycle [ Time Frame: 28 days ]
   Number of dose-limiting toxicities during the first cycle
2. Estimation of PFS rate at 6 months [ Time Frame: 6 months ]
   PFS rate for each of the combination arms in patients who received prior ET and CDK4/6i in the metastatic setting

Secondary Outcome Measures :

1. Standard PK parameters including AUC0-tau, Cmax, Tmax, and Ctrough [ Time Frame: 36 months ]
   The plasma PK of elacestrant and each of the combination drugs
2. Overall Response Rate [ Time Frame: 36 months ]
   Proportion of patients who achieve a best overall response (BOR) of confirmed partial response (PR) or complete response (CR)
3. Duration of Response [ Time Frame: 36 months ]
   Time from the date of the first documented CR/PR until the first radiological documentation of disease progression or death
4. Clinical Benefit Rate [ Time Frame: 36 months ]
   Proportion of patients who have the best overall response with a complete response, partial response or stable disease
5. Progression-free survival [ Time Frame: 36 months ]
   Time from the date of the first dose to the date of the first radiological documentation of disease progression or death, whichever occurs first
6. Overall Survival [ Time Frame: 36 months ]
   Time from the date of the first dose to the date of death from any cause

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Patient 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 patients may be of any menopausal status.

   • Postmenopausal status is defined by:

     1. Age ≥60 years
     2. Age <60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) or a follicle-stimulating hormone (FSH) value >40 mIU/mL and an estradiol value<40 pg/mL (140 pmol/L) or in postmenopausal ranges per local reference ranges
     3. Documentation of prior surgical sterilization (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, at least 1 month before first dose of trial therapy).
   • Premenopausal and perimenopausal women (who do not fit postmenopausal criteria) and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist initiated at least 4 weeks before the start of trial therapy and are planning to continue LHRH agonist treatment during the study treatment.
   • For perimenopausal women to be considered of non-childbearing potential, FSH levels must be >40 mIU/ml.
3. Histopathological or cytological confirmed ER+, HER2-, breast cancer, per local laboratory, as per the American Society of Clinical Oncology (ASCO)/College of American Pathologists(CAP) guidelines (Allison et al, 2020, Wolff et al, 2018). Note: In the context of this trial, ER status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with or without PGR positivity. .
4. At least 1 not previously irradiated measurable lesion as per RECIST version 1.1 and/or at least 1 lytic or mixed (lytic +sclerotic) bone lesion with identifiable soft tissue components meeting the definition of measurability by RECIST version 1.1 that can be evaluated by CT or MRI; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible.
5. ECOG performance status of 0 or 1.

6. Patient has adequate bone marrow and organ function, as defined by the following laboratory values:

   1. Absolute neutrophil count (ANC) ≥1.5 × 10^9/L
   2. Platelets ≥100 × 10^9/L
   3. Hemoglobin ≥9.0 g/dL
   4. Potassium, sodium, calcium (corrected for serum albumin) and magnesium CTCAE grade ≤1

   5. Creatinine is ≤ 1.5 x ULN or if creatinine is > 1.5 x ULN, then creatinine clearance must be ≥50 mL/min based on the Cockcroft-Gault formula. Note: C-G formula:

      • Creatinine clearance (male) = ([140-age in years] × weight in kg)/ ([serum creatinine in mg/dL] × 72)
      • Creatinine clearance (female) = (0.85 × [140-age in years] × weight in kg)/ ([serum creatinine in mg/dL] × 72)
   6. Serum albumin ≥3.0 g/dL (≥30 g/L)
   7. In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN. If the patient has liver metastases, ALT and AST ≤ 5 × ULN
   8. Total serum bilirubin <1.5 × ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN.

Exclusion Criteria:

1. Active or newly diagnosed CNS metastases, including meningeal carcinomatosis. Note: Patients with stable brain or subdural metastases are allowed if the patient has completed local therapy and was on a stable or decreasing dose of corticosteroids at baseline for management of brain metastasis for at least 4 weeks before starting treatment in this study. The dose must be ≤2.0 mg/day of dexamethasone or equivalent. Any signs (e.g., radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
2. Patients with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement >50%.
3. Prior chemotherapy or elacestrant in the advanced/metastatic setting.
4. Patients with known germline BRCA mutation without prior treatment with a PARP inhibitor before study entry.
5. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders (SERDs), or investigational alike agents such as selective estrogen receptor modulators (SERM), selective estrogen receptor covalent antagonists (SERCANs), complete estrogen receptor antagonists (CERANs), and proteolysis-targeting chimeras (PROTACs), in the metastatic setting. Prior treatment with fulvestrant is not exclusionary as it is an approved medication.
6. Patient has a concurrent malignancy or history of invasive malignancy within 3 years of enrollment, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix that has completed curative therapy. Other malignancies with low risk of recurrence may be considered eligible with Sponsor approval.

7. Uncontrolled significant active infections. • Patients with HBV and/or HCV infection must have undetectable viral load during screening.

   • Patients known to be HIV+ are allowed if they have undetectable viral load at baseline.

8. Documented pneumonitis/ILD prior to Cycle 1 Day 1.
9. Major surgery within 28 days before starting trial therapy.
10. Inability to take oral medications, refractory or chronic nausea, gastrointestinal conditions (including significant gastric or bowel resection), history of malabsorption syndrome, or any other uncontrolled gastrointestinal condition that impact the absorption of the study drug.
11. Known intolerance to elacestrant or any of its excipients.

12. Pregnant and breast-feeding women are excluded from the study. In addition, women of childbearing potential are excluded who:

    • Within 28 days before starting trial therapy, did not use a highly effective method of contraception.

    • Do not agree to use a highly effective method of contraception (Appendix F) or abstain from heterosexual intercourse throughout the entire study period and for 120 days after trial therapy discontinuation.

13. Men or women who do not agree to abstain from donating sperm or ova, or to use a highly effective method of contraception, during the course of the treatment period and for 120 days after the last dose of study treatment.

14. Patient is currently receiving or received any of the following medications prior to first dose of trial therapy:

    • Anti-cancer therapy within 14 days (28 days for anticancer antibody based treatment) or 5 half-lives, whichever is shorter.

    Please note: Toxicity from prior therapy must be resolved to NCI CTCAE version 5.0 Grade ≤1, except alopecia and peripheral sensory neuropathy (Grade ≤2).

    • Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 within 14 days or 5 half-lives, whichever is shorter, (refer to http://medicine.iupui.edu/clinpharm/ddis/ or https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers).

    • Herbal preparations/medications within 7 days. These include, but are not limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.

    • Vaccination, including but not limited to vaccination against COVID-19, during the 7 days prior to randomization.

15. Evidence of ongoing alcohol or drug abuse as assessed by the investigator.
16. Any severe medical or psychiatric condition that, in the Investigator's opinion, would preclude the patient's participation in a clinical study.

Additional Eligibility for the Alpelisib Combination (Phase 1b and Arm A)

Inclusion:

In general, the SmPC of the respective combination drug should be consulted for instructions/restrictions with respect to interactions with concomitant medications.

1. PIK3CA mutation by local laboratory assessment.
2. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.

Exclusion:

1. Prior therapy with alpelisib or any other PI3K inhibitor.
2. Type 1 diabetes or uncontrolled type 2 diabetes (fasting plasma glucose level of >140 mg/dL [7.7 mmol/L], or glycosylated hemoglobin [HbA1c] level of >6.4%).
3. Known intolerance to alpelisib or any of its excipients.
4. Patient is currently receiving or received drugs known to be a BCRP inhibitor within 14 days or 5 half-lives, whichever is shorter, prior to first dose of trial therapy
5. Patient has ongoing osteonecrosis of the jaw from previous or concurrent treatment with bisphosphonates or denosumab

Additional Eligibility for the Everolimus Combination (Phase 1b and Arm B)

Inclusion:

1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.

Exclusion:

1. Prior therapy with everolimus.
2. Known intolerance to everolimus or any of its excipients.

Additional Eligibility for the Abemaciclib Combination (Arm C)

Inclusion:

1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.

Exclusion:

1. Prior therapy with abemaciclib in the advanced or metastatic setting. Adjuvant therapy with abemaciclib is exclusionary if the patient relapsed within the past 12 months.
2. Known intolerance to abemaciclib or any of its excipients.

Additional Eligibility for the Ribociclib Combination (Phase 1b and Arm C)

Inclusion:

1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.

Exclusion:

1. Prior therapy with ribociclib in the metastatic setting. Prior adjuvant therapy with ribociclib is also exclusionary if the patient relapsed within the past 12 months.
2. Known intolerance to ribociclib or any of its excipients.
3. QTcF values ≥450 msec.

4. Patients who already have or who are at significant risk of developing QTc prolongation, including patients with:

   • Long QT syndrome
   • Uncontrolled or significant cardiac disease including recent (6 months) myocardial infarction, congestive heart failure, unstable angina, and brady-arrhythmias
   • Electrolyte abnormalities
5. Patient is currently receiving or received drugs known to prolong QT interval within 14 days or 5 half-lives, whichever is shorter, before the first dose of trial therapy.

Additional Eligibility for the Palbociclib Combination (Phase 1b)

Inclusion:

1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor.

Exclusion:

1. Prior therapy with palbociclib in the metastatic setting.
2. Known intolerance to palbociclib or any of its excipients

Additional Eligibility for the Palbociclib Combination (Arm D)

Inclusion:

1. One or up to two prior hormonal therapies in the advanced or metastatic setting.

Exclusion:

1. Prior therapy with a CDK4/6i in the metastatic setting.
2. Known intolerance to palbociclib or any of its excipients.

Additional Eligibility for the Abemaciclib Combination (Arm D)

Inclusion:

1. One or up to two prior hormonal therapies in the advanced or metastatic setting.

Exclusion:

1. Prior therapy with any CDK4/6i in the metastatic setting.
2. Known intolerance to abemaciclib or any of its excipients.

Additional Eligibility for Ribociclib Combination (Arm D)

Inclusion:

1. One or up to two prior hormonal therapies in the advanced or metastatic setting.

Exclusion:

1. Prior therapy with a CDK4/6i in the advanced or metastatic setting.
2. Known intolerance to ribociclib or any of its excipients.
3. QTcF values ≥450 msec.

4. Patients who already have or who are at significant risk of developing QTc prolongation, including patients with:

   • Long QT syndrome
   • Uncontrolled or significant cardiac disease including recent (6 months) myocardial infarction, congestive heart failure, unstable angina, and brady-arrhythmias
   • Electrolyte abnormalities
5. Patient is currently receiving or received drugs known to prolong QT interval within 14 days or 5 half-lives, whichever is shorter, before the first dose of trial therapy.

Contacts and Locations

Contacts

Contact: Stemline Trials; 718-509-3742; trials@stemline.com

Contact: Mary Ann Samparani; 646-731-2146; msamparani@stemline.com

Locations

United States, Alabama

Dothan Hematology and Oncology; Recruiting

Dothan, Alabama, United States, 36303

Principal Investigator: Jawaunna Blackmon

United States, Arizona

Mayo Clinic - Arizona; Recruiting

Phoenix, Arizona, United States, 85054

Contact: Felipe Batalini

United States, Arkansas

Highlands Oncology Group; Recruiting

Springdale, Arkansas, United States, 72762

Contact: Thaddeus Beck

United States, California

OPN Healthcare (Arcadia Location); Recruiting

Arcadia, California, United States, 91007

Contact: Anthony Lam

Glendale Adventist; Recruiting

Glendale, California, United States, 91206

Contact: Mihran Shirinian

OPN Healthcare (Los Alamitos Location); Recruiting

Los Alamitos, California, United States, 90720

Contact: Nihal Abdulla

Cedars Sinai; Recruiting

Los Angeles, California, United States, 90048

Contact: Yuan Yuan

UCSF Helen Diller Family Comprehensive Cancer Center; Recruiting

San Francisco, California, United States, 94158

Contact: Hope Rugo

TOI Clinical Research; Recruiting

Whittier, California, United States, 90603

Principal Investigator: Paul La Porte

United States, Colorado

Rocky Mountain Cancer Centers; Recruiting

Lone Tree, Colorado, United States, 80124

Contact: Mabel Bupathi

United States, Connecticut

Yale School Of Medicine - Smilow Cancer Hospital - Breast Center; Recruiting

New Haven, Connecticut, United States, 06519

Contact: Pusztai Lajos

United States, District of Columbia

George Washington Cancer Center; Recruiting

Washington, District of Columbia, United States, 20037

Contact: Pavani Chalasani

United States, Florida

Advent Health (Florida Hospital) - Altamonte Springs; Recruiting

Altamonte Springs, Florida, United States, 32701

Contact: McHayleh Wassim

Mayo Clinic - Jacksonville; Recruiting

Jacksonville, Florida, United States, 32224

Contact: Kostandinos Sideras

Ocala Oncology; Recruiting

Ocala, Florida, United States, 34474

Principal Investigator: Anju Vasudevan

United States, Illinois

Northwestern Feinberg Scholl of Medicine Prentice Women's Hospital; Recruiting

Chicago, Illinois, United States, 60611

Contact: William Gradishar

United States, Kansas

MD Alliance for Multispecialty Research, LLC; Recruiting

Merriam, Kansas, United States, 66204

Principal Investigator: Jaswinder Singh, MD

United States, Maine

New England Cancer Specialists; Recruiting

Scarborough, Maine, United States, 04074

Contact: Chiara Battelli

United States, Massachusetts

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Aditya Bardia

Dana Farber Cancer Institute; Recruiting

Boston, Massachusetts, United States, 02215

Contact: Sara Tolaney

United States, Michigan

Barbara Ann Karmanos Cancer Institute; Recruiting

Detroit, Michigan, United States, 48201

Contact: Hadeel Assad

United States, Minnesota

Minnesota Oncology Hematology; Recruiting

Minneapolis, Minnesota, United States, 55404

Contact: Liu Yang

Mayo Clinic - Rochester; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Karthik Giridhar

United States, Missouri

Washington University School of Medicine in St. Louis; Recruiting

Saint Louis, Missouri, United States, 63110

Contact: Nusayba Bagegni

United States, New Jersey

Astera Cancer Care; Recruiting

East Brunswick, New Jersey, United States, 08816

Contact: Bruno Fang

Summit Medical Group; Recruiting

Florham Park, New Jersey, United States, 07932

Contact: Steven Papish

United States, New York

NYU Langone Health; Recruiting

New York, New York, United States, 10016

Contact: Nancy Chan

New York Cancer and Blood Specialists; Recruiting

Port Jefferson Station, New York, United States, 11776

Contact: Richard Zuniga

United States, Rhode Island

W&IH of RI Breast Health Center of Women and Infants Hospital of Rhode Island; Recruiting

Providence, Rhode Island, United States, 02905

Contact: William Sikov 401-453-7520

Principal Investigator: William Sikov

United States, Tennessee

Sarah Cannon Research Institute / Tennessee Oncology; Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator: Erika Hamilton

United States, Texas

Texas Oncology - Baylor Charles A. Sammons Cancer Center; Recruiting

Dallas, Texas, United States, 75246

Contact: O'Shaughnessy Joyce

MD Anderson Cancer Center Texas; Recruiting

Houston, Texas, United States, 77030

Contact: Vincente Valero

Principal Investigator: Vincente Valero

UT Health San Antonio; Recruiting

San Antonio, Texas, United States, 78229

Contact: Kaklamani Virginia

United States, Virginia

Inova Schar Cancer Institute; Recruiting

Fairfax, Virginia, United States, 22031

Contact: Kathleen Harnden

Virginia Cancer Specialists; Recruiting

Fairfax, Virginia, United States, 22031

Contact: Mohamed Salkeni

Virginia Oncology Associates; Recruiting

Norfolk, Virginia, United States, 23502

Contact: Michael Danso

United States, Washington

Cancer Care Northwest; Recruiting

Spokane Valley, Washington, United States, 99216

Contact: Kristine Rinn

Northwest Medical Specialties (Nwms) - Puyallup - Medical Oncology (Rainier Hematology-Oncology)/Exigent Research Network; LLC; Recruiting

Tacoma, Washington, United States, 98405

Contact: Sibel Blau

United States, Wisconsin

University of WI - Carbone Cancer Center (Phase II only); Recruiting

Madison, Wisconsin, United States, 53792

Contact: Sharifi Marina

Sponsors and Collaborators

Stemline Therapeutics, Inc.

More Information

• Responsible Party: Stemline Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05563220
• Other Study ID Numbers: STML-ELA-0222
• First Posted: October 3, 2022
• Last Update Posted: April 8, 2024
• Last Verified: April 2024

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stemline Therapeutics, Inc.:

breast cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Everolimus; Palbociclib; MTOR Inhibitors; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antineoplastic Agents