Trials / Active Not Recruiting
Active Not RecruitingNCT05307705
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 193 (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LOXO-783 | Oral |
| DRUG | Fulvestrant | Intramuscular |
| DRUG | Imlunestrant | Oral |
| DRUG | Abemaciclib | Oral |
| DRUG | Anastrozole, Exemestane, or Letrozole | Oral |
| DRUG | Paclitaxel | Intravenous |
Timeline
- Start date
- 2022-05-11
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2022-04-01
- Last updated
- 2026-03-27
Locations
45 sites across 11 countries: United States, Australia, Belgium, China, France, Germany, Japan, Singapore, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05307705. Inclusion in this directory is not an endorsement.