A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company
About this trial
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.
Eligibility criteria
Qualifiers
Have advanced breast cancer or another solid tumor with the presence of a phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)
Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.
Have stopped all cancer treatment and have recovered from the major side effects
Have adequate organ function, as measured by blood tests
Disqualifiers
Medical Conditions
Colorectal cancer
Endometrial cancers with specific concurrent oncogenic alterations
A history of known active or suspected
Trial design
Treatments tested in this trial
- LOXO-783
- Fulvestrant
- Imlunestrant
- Abemaciclib
- Anastrozole, Exemestane, or Letrozole
- Paclitaxel
Treatment groups
260 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov