Breast Neoplasm Malignant FemaleNCT05134922
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
A study testing Gedatolisib in people with Breast Neoplasm Malignant Female, run by Celcuity Inc at 5 sites in United States.
Trial summary
Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Malignant Female
- What is being tested?
- Gedatolisib
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Who may be able to join
- Currently enrolled in the B2151009 clinical study and benefiting from treatment with gedatolisib in combination with other therapies as determined by the Investigator
- Previously demonstrated compliance and are willing and able to comply with scheduled visits, treatment plans, and other study procedures
- No evidence of progressive disease, as determined by the Investigator
- Provide written informed consent prior to enrolling and receiving treatment
Who cannot join
- Permanently discontinued from treatment in Study B2151009, or discontinued from Study B2151009 for any reason
- Women who are pregnant, intend to become pregnant, or nursing
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
- Available
University of Michigan
Ann Arbor, Michigan, 48109
Anne F Schott, MD, 734-936-6266, aschott@med.umich.edu
- Available
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Erica Stringer-Reasor, MD, esreasor@uabmc.edu
- Available
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Robert Weslowski, MD, robert.wesolowski@osumc.edu
- Available
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Rachel Layman, MD, rlayman@mdanderson.org
- Available
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Jennifer Specht, MD, 206-606-6768, jspecht@uw.edu
About this study
Official title: Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in a Celcuity-Sponsored Clinical Study (B2151009)
Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.
Read the detailed description
The primary purpose of this study is to provide continuing access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.
- Conditions
- Breast Neoplasm Malignant Female
- Being tested
- Gedatolisib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GedatolisibDrug
Gedatolisib is a potent, reversible dual inhibitor that selectively targets phosphoinositide 3 kinase (PI3K) and mammalian target of rapamycin (mTOR) in biochemical and cellular assays.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm Malignant FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Celcuity Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134922
- Sponsor's protocol ID
- CELC-G-001
- Status last verified
- Mar 2025
- First submitted
- 14 Nov 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in a Celcuity-Sponsored Clinical Study (B2151009)
- ClinicalTrials.gov ID
- NCT05134922
- Acronym / sponsor ID
- CELC-G-001
- Conditions
- Breast Neoplasm Malignant Female
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Celcuity IncIndustry (pharma, biotech, devices)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.
Detailed description
The primary purpose of this study is to provide continuing access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Currently enrolled in the B2151009 clinical study and benefiting from treatment with gedatolisib in combination with other therapies as determined by the Investigator
- Previously demonstrated compliance and are willing and able to comply with scheduled visits, treatment plans, and other study procedures
- No evidence of progressive disease, as determined by the Investigator
- Provide written informed consent prior to enrolling and receiving treatment
Key exclusion criteria (2 listed)
- Permanently discontinued from treatment in Study B2151009, or discontinued from Study B2151009 for any reason
- Women who are pregnant, intend to become pregnant, or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GedatolisibGedatolisib is a potent, reversible dual inhibitor that selectively targets phosphoinositide 3 kinase (PI3K) and mammalian target of rapamycin (mTOR) in biochemical and cellular assays. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gedatolisib in people with Breast Neoplasm Malignant Female, run by Celcuity Inc at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadene Zack, MS (844-310-3900, nzack@celcuity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.