Clinical Trials
Ongoing Clinical Studies
REVTORPYK (gedatolisib) is currently in development for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer and for the second-line treatment of metastatic castration-resistant prostate cancer.
Tumor Type
Breast Cancer
Study Name
VIKTORIA-1
Phase
Phase 3
Status
Enrollment Complete
VIKTORIA-1 is a Phase 3 study evaluating gedatolisib plus fulvestrant with and without palbociclib as a 2nd-line treatment for patients with HR+/HER2- advanced breast cancer previously treated with a CDK4/6 therapy and an aromatase inhibitor.
For more information about the VIKTORIA-1 trial, please visit our clinical trial website. Full details, including eligibility and study locations, are also available on ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT05501886
Tumor Type
Breast Cancer
Study Name
VIKTORIA-2
Phase
Phase 3
Status
Ongoing
VIKTORIA-2 is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant and palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer. Patients will be assigned manually according to their endocrine sensitivity status to either Study 1 (endocrine-resistant) or Study 2 (endocrine-sensitive) and subsequently be randomized 1:1 to either investigational treatment or standard-of-care control.
VIKTORIA-2 is currently enrolling patients at sites across North America, Europe, Latin America and Asia. For more information about the VIKTORIA-2 trial, please visit our clinical trial website. Full details, including eligibility and study locations, are also available on ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT06757634
Tumor Type
Prostate Cancer
Study Name
CELC-G-201
Phase
Phase 1/2
Status
Ongoing
CELC-G-201 is a Phase 1/2 clinical trial evaluating gedatolisib plus darolutamide, an androgen receptor (AR) inhibitor, in patients previously treated with an AR inhibitor for metastatic castration resistant prostate cancer (mCRPC).
CELC-G-201 is currently enrolling patients. Full details, including eligibility and study locations, are available on ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT06190899
Expanded Access Program
The best way for eligible patients to access medicines prior to approval is through participation in clinical trials. To participate in a trial, you must meet certain criteria. For those who meet the criteria to join a clinical trial, participation offers the chance to contribute to medical research that may benefit many others.
In cases where a clinical trial isn’t an option or following approval of a medicine in cases where commercial product is not yet available, health authorities may grant permission for Celcuity to provide a treating physician with access to an investigational drug. These programs are called “expanded access” or “compassionate use” but may go by other names. Celcuity refers to these requests as expanded access. Physician requests for participation in Celcuity’s expanded access program may be made by emailing: gedatolisib@tannerpharma.com.
We encourage patients to speak first with their physician about their eligibility to enroll in a clinical trial or their need for an investigational medicine that has been approved but is supply constrained. If a treating physician believes expanded access may be the only option for a patient, the physician should contact Celcuity to make a formal request on behalf of the patient. This will enable the physician to work with Celcuity’s Medical team to determine the best course of action.
The request for access an investigational Celcuity product can only be considered if the patient’s treating physician is committed to, and supportive of, the requested treatment.
