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A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (PIKASSO-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05307705
Recruitment Status : Recruiting
First Posted : April 1, 2022
Last Update Posted : March 20, 2024
Sponsor:
Collaborator:
Loxo Oncology, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: LOXO-783 Drug: Fulvestrant Drug: Imlunestrant Drug: Abemaciclib Drug: Anastrozole, Exemestane, or Letrozole Drug: Paclitaxel Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 11, 2022
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1A: LOXO-783 Monotherapy Dose Escalation
LOXO-783 administered orally
 Drug: LOXO-783
Oral
Other Name: LY3849524
Experimental: Phase 1B: Part A
LOXO-783 administered orally in combination with fulvestrant intramuscularly, imlunestrant orally, or an aromatase inhibitor orally
 Drug: LOXO-783
Oral
Other Name: LY3849524

Drug: Fulvestrant
Intramuscular

Drug: Imlunestrant
Oral
Other Name: LY3484356

Drug: Anastrozole, Exemestane, or Letrozole
Oral
Experimental: Phase 1B: Part B
LOXO-783 orally in combination with abemaciclib and either physician's choice aromatase inhibitor orally, fulvestrant intramuscularly, or imlunestrant orally
 Drug: LOXO-783
Oral
Other Name: LY3849524

Drug: Fulvestrant
Intramuscular

Drug: Imlunestrant
Oral
Other Name: LY3484356

Drug: Abemaciclib
Oral
Other Name: LY2835219

Drug: Anastrozole, Exemestane, or Letrozole
Oral
Experimental: Phase 1B: Part C
LOXO-783 orally in combination with fulvestrant intramuscularly
 Drug: LOXO-783
Oral
Other Name: LY3849524

Drug: Fulvestrant
Intramuscular
Experimental: Phase 1B: Part D
LOXO-783 orally in combination with paclitaxel intravenously
 Drug: LOXO-783
Oral
Other Name: LY3849524

Drug: Paclitaxel
Intravenous
Experimental: Phase 1B: Part E
LOXO-783 orally
 Drug: LOXO-783
Oral
Other Name: LY3849524
Experimental: Phase 1B: Part F
Multiple randomized dose levels of LOXO-783 orally with fulvestrant intramuscularly
 Drug: LOXO-783
Oral
Other Name: LY3849524

Drug: Fulvestrant
Intramuscular


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: During the first 28-day cycle of LOXO-783 treatment ]
    Number of patients with DLTs

  2. Phase 1 a: To determine the MTD/RP2D of LOXO-783: Number of patients with DLT-equivalent toxicities [ Time Frame: During the first 28-day cycle of LOXO-783 treatment ]
    Number of patients with DLT-equivalent toxicities


Secondary Outcome Measures :
  1. To assess the pharmacokinetics (PK) of LOXO-783: Area under the concentration versus time curve (AUC) [ Time Frame: Up to 2 months ]
    PK of LOXO-783: AUC

  2. To assess the PK of LOXO-783: Maximum drug concentration (Cmax) [ Time Frame: Up to 2 months ]
    PK of LOXO-783: Cmax

  3. To evaluate the preliminary antitumor activity of LOXO-783: Overall response rate (ORR) [ Time Frame: Up to approximately 36 months or 3 years ]
    ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

  4. To evaluate the preliminary antitumor activity of LOXO-783: Best overall response (BOR) [ Time Frame: Up to approximately 36 months or 3 years ]
    BOR per investigator assessed RECIST 1.1

  5. To evaluate the preliminary antitumor activity of LOXO-783: Duration of response (DOR) [ Time Frame: Up to approximately 36 months or 3 years ]
    DOR per investigator assessed RECIST 1.1

  6. To evaluate the preliminary antitumor activity of LOXO-783: Disease control rate (DCR) [ Time Frame: Up to approximately 36 months or 3 years ]
    DCR per investigator assessed RECIST 1.1

  7. To evaluate the preliminary antitumor activity of LOXO-783: Clinical benefit rate (CBR) [ Time Frame: Up to approximately 36 months or 3 years ]
    CBR per investigator assessed RECIST 1.1

  8. To evaluate the preliminary antitumor activity of LOXO-783: Time to response (TTR) [ Time Frame: Up to approximately 36 months or 3 years ]
    TTR per investigator assessed RECIST 1.1

  9. To evaluate the preliminary antitumor activity of LOXO-783: Progression free survival (PFS) [ Time Frame: Up to approximately 36 months or 3 years ]
    PFS per investigator assessed RECIST 1.1

  10. To evaluate the preliminary antitumor activity of LOXO-783: Overall survival (OS) [ Time Frame: Up to approximately 36 months or 3 years ]
    OS per investigator assessed RECIST 1.1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05307705


Contacts
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Contact: Patient Advocacy 855-569-6305 clinicaltrials@loxooncology.com;

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Loxo Oncology, Inc.
Investigators
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Study Director: Vincent Chau, MD; PhD Loxo Oncology, Inc.
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05307705    
Other Study ID Numbers: LOXO-PIK-21001
J4C-OX-JZUA ( Other Identifier: Eli Lilly and Company )
2022-000175-40 ( EudraCT Number )
First Posted: April 1, 2022    Key Record Dates
Last Update Posted: March 20, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Letrozole
Fulvestrant
Anastrozole
Exemestane
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists