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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
193
Phase 1 a: To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of LOXO-783: Number of patients with dose-limiting toxicities (DLTs)
Number of patients with DLTs
Time frame: During the first 28-day cycle of LOXO-783 treatment
Phase 1 a: To determine the MTD/RP2D of LOXO-783: Number of patients with DLT-equivalent toxicities
Number of patients with DLT-equivalent toxicities
Time frame: During the first 28-day cycle of LOXO-783 treatment
To assess the pharmacokinetics (PK) of LOXO-783: Area under the concentration versus time curve (AUC)
PK of LOXO-783: AUC
Time frame: Up to 2 months
To assess the PK of LOXO-783: Maximum drug concentration (Cmax)
PK of LOXO-783: Cmax
Time frame: Up to 2 months
To evaluate the preliminary antitumor activity of LOXO-783: Overall response rate (ORR)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Time frame: Up to approximately 36 months or 3 years
To evaluate the preliminary antitumor activity of LOXO-783: Best overall response (BOR)
BOR per investigator assessed RECIST 1.1
Time frame: Up to approximately 36 months or 3 years
To evaluate the preliminary antitumor activity of LOXO-783: Duration of response (DOR)
DOR per investigator assessed RECIST 1.1
Time frame: Up to approximately 36 months or 3 years
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Oral
Intravenous
Mayo Clinic of Scottsdale
Scottsdale, Arizona, United States
UCLA Medical Center
Los Angeles, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States
Stanford University Hospital
Stanford, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Winship Cancer Center Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University Medical School
St Louis, Missouri, United States
...and 40 more locations
To evaluate the preliminary antitumor activity of LOXO-783: Disease control rate (DCR)
DCR per investigator assessed RECIST 1.1
Time frame: Up to approximately 36 months or 3 years
To evaluate the preliminary antitumor activity of LOXO-783: Clinical benefit rate (CBR)
CBR per investigator assessed RECIST 1.1
Time frame: Up to approximately 36 months or 3 years
To evaluate the preliminary antitumor activity of LOXO-783: Time to response (TTR)
TTR per investigator assessed RECIST 1.1
Time frame: Up to approximately 36 months or 3 years
To evaluate the preliminary antitumor activity of LOXO-783: Progression free survival (PFS)
PFS per investigator assessed RECIST 1.1
Time frame: Up to approximately 36 months or 3 years
To evaluate the preliminary antitumor activity of LOXO-783: Overall survival (OS)
OS per investigator assessed RECIST 1.1
Time frame: Up to approximately 36 months or 3 years