LOXO-783 for Breast Cancer

(PIKASSO-01 Trial)

Recruiting at 83 trial locations

Overseen By Patient Advocacy

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must be taking: CDK4/6 inhibitors

Must not be taking: Antidiabetic medications

Disqualifiers: Colorectal cancer, Endometrial cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 36 months

193 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop all cancer treatments and recover from major side effects before participating. The protocol does not specify about other medications, so it's best to discuss your current medications with the trial team.

How is the drug LOXO-783 different from other breast cancer treatments?

LOXO-783 is unique because it is a targeted therapy, potentially offering a more precise approach to treating breast cancer compared to traditional chemotherapy, which affects both cancerous and healthy cells. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing LOXO-783, a new drug, to see if it is safe and effective for patients with breast cancer and other solid tumors that have a change in the PIK3CA gene. The drug works by blocking a gene that helps cancer cells grow.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for adults with advanced breast cancer or other solid tumors that have a specific gene change (PIK3CA mutation). Participants can have had several prior treatments but must be recovered from their side effects. They need to have measurable disease, adequate organ function, and an ECOG performance status of 0 or 1. Women should be postmenopausal; men agree to hormone suppression.

Inclusion Criteria

I have an advanced solid tumor and have had up to 3 treatments for it.

My breast cancer is ER+ and HER2- and I've had up to 2 treatments for advanced disease.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I do not have any active, uncontrolled infections or significant diseases.

I have colorectal cancer.

You have a serious health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LOXO-783 as monotherapy or in combination with other anticancer therapies

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term if the disease does not progress

Long-term

Treatment Details

Interventions

• LOXO-783

Trial Overview LOXO-783 is being tested for its safety and effectiveness in treating certain cancers. The study will explore how well it works on tumors with the PIK3CA gene mutation over a period of up to three years. Patients may also receive other standard cancer treatments like Fulvestrant or Abemaciclib as part of the study.

Participant Groups

Group I: Phase 1B: Part F Experimental Treatment 2 Interventions

Multiple randomized dose levels of LOXO-783 orally with fulvestrant intramuscularly

Group II: Phase 1B: Part E Experimental Treatment 1 Intervention

LOXO-783 orally

Group III: Phase 1B: Part D Experimental Treatment 2 Interventions

LOXO-783 orally in combination with paclitaxel intravenously

Group IV: Phase 1B: Part C Experimental Treatment 2 Interventions

LOXO-783 orally in combination with fulvestrant intramuscularly

Group V: Phase 1B: Part B Experimental Treatment 5 Interventions

LOXO-783 orally in combination with abemaciclib and either physician's choice aromatase inhibitor orally, fulvestrant intramuscularly, or imlunestrant orally

Group VI: Phase 1B: Part A Experimental Treatment 4 Interventions

LOXO-783 administered orally in combination with fulvestrant intramuscularly, imlunestrant orally, or an aromatase inhibitor orally

Group VII: Phase 1A: LOXO-783 Monotherapy Dose Escalation Experimental Treatment 1 Intervention

LOXO-783 administered orally

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Loxo Oncology, Inc.

Industry Sponsor

Trials

72

Recruited

11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology

References

1. Greece pubmed.ncbi.nlm.nih.gov

A new micronized formulation of 2-methoxyestradiol-bis-sulfamate (STX140) is therapeutically potent against breast cancer. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Comparative trial of nafoxidine and ethinyloestradiol in advanced breast cancer: an E.O.R.T.C. study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

4-hydroxyandrostenedione: a new treatment for postmenopausal patients with breast cancer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical trial of nafoxidine in adrenalectomized patients with advanced breast cancer. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Breast intraductal nanoformulations for treating ductal carcinoma in situ I: Exploring metal-ion complexation to slow ciclopirox release, enhance mammary persistence and efficacy. [2021]