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

Study Identifier:
LOXO-PIK-21001
CT.gov Identifier:
NCT05307705
EudraCT Identifier:
2022-000175-40
EU Trial (CTIS) Number:
2023-509568-81-00
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

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Study Summary

To evaluate pharmacokinetics , efficacy and safety of LOXO-783 in patients with Advanced Breast Cancer.

To investigates LOXO-783 alone and in combination with other anticancer therapies in patients with PIK3CA H1047R-mutant aBC and other solid tumors.

To determine the safety, tolerability, PK, and antitumor activity of LOXO-783 in patients with PIK3CA H1047R-mutant advanced BC (aBC) and other

solid tumors

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast Cancers
  • Ovarian
  • Pancreas
  • Soft Tissue Sarcoma
  • Thyroid
  • Esophageal
  • Astrocytoma
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Phase 1A: LOXO-783 Monotherapy Dose Escalation
    • Read More
  • Drug: Experimental: Phase 1B: Part A
  • Drug: Drug: Fulvestrant
  • Drug: Drug: Imlunestrant
  • Drug: Drug: Anastrozole, Exemestane, or Letrozole
  • Drug: Experimental: Phase 1B: Part B
  • Drug: Drug: Abemaciclib
  • Drug: Experimental: Phase 1B: Part C
  • Drug: Experimental: Phase 1B: Part D
  • Drug: Drug: Paclitaxel
  • Drug: Experimental: Phase 1B: Part E
  • Drug: Experimental: Phase 1B: Part F
  • Drug: Chinese common name: NA
  • Drug: Chinese common name: Fulvestrant
  • Drug: Chinese common name: Abemaciclib
  • Drug: Chinese common name: Paclitaxel
  • Drug: Chinese common name: Anastrozole
  • Drug: Chinese common name: Exemestane
  • Drug: Chinese common name: Letrozole
  • Drug: In ph1a, pts received monotherapy doses from 200 600 mg BID or 500 600 mg QD.
  • Drug: Phase 1b (ph1b)included the evaluation of LOXO-783 plus (+) endocrine therapy (ET: fulvestrant [F] /aromatase inhibitor [AI]), or LOXO-783 + paclitaxel (P) in PI3Ki-naive/intolerant pts with PIK3CA H1047R aBC.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    Inclusion criteria
    • 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 -Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale -Patients must have -Measurable disease ---Patients with non-breast tumor types must have at least 1 measurable lesion -Non-measurable bone disease (at least 1 bone lesion in breast cancer patients only) -For patients with an estrogen receptor (ER) + breast cancer diagnosis: -If female, must be postmenopausal -If male, must agree to use hormone suppression -Phase 1a: --Dose escalation and backfill patients: -Advanced solid tumor -Patients may have had up to 5 prior regimens for advanced disease -Phase 1b: -Part A: -ER+/human epidermal growth factor receptor 2 (HER2) - advanced breast cancer -Patients may have had up to 5 prior regimens for advanced disease ----Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required -Part B: -ER+/HER2- advanced breast cancer -Patients may have had up to 2 prior regimens for advanced disease. -Part C: -ER+/HER2- advanced breast cancer -Patients may have had up to 5 prior regimens for advanced disease. ----Prior CDK4/6 inhibitor therapy required. -Have a diagnosis of diabetes mellitus Type 2 -Part D: -Advanced breast cancer -Patients may have had up to 5 prior regimens for advanced disease. -Part E: -Advanced solid tumor -Patients may have had up to 3 prior regimens for advanced disease -Part F: -ER+/HER2- advanced breast cancer -Patients may have had up to 5 prior regimens for advanced disease -Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required
    Exclusion criteria
    • Medical Conditions -Colorectal cancer -Endometrial cancers with specific concurrent oncogenic alterations -A history of known active or suspected -Diabetes mellitus Type 1 or -Diabetes mellitus Type 2 requiring antidiabetic medication (Phase 1a and all parts of Phase 1b except Part C). -Serious concomitant systemic disorder -Known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement. -Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process -Prior exposure to phosphatidylinositol 3-kinase/protein kinase B/mammalian target of rapamycin (PI3K/AKT/mTOR) inhibitor(s), except in certain circumstances

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Breast Cancers
    Ovarian
    Pancreas
    Soft Tissue Sarcoma
    Thyroid
    Esophageal
    Astrocytoma