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LOXO-783 for Breast Cancer (PIKASSO-01 Trial)
PIKASSO-01 Trial Summary
This trial is to study the safety and effectiveness of LOXO-783 for treating breast cancer and other solid tumors.
PIKASSO-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPIKASSO-01 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PIKASSO-01 Trial Design
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Who is running the clinical trial?
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- I do not have any active, uncontrolled infections or significant diseases.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.I am a woman and postmenopausal or a man agreeing to hormone suppression for my ER+ breast cancer.I have ER+/HER2- advanced breast cancer, treated with up to 5 regimens and a CDK4/6 inhibitor. I also have Type 2 diabetes.My breast cancer is ER+ and HER2- and I've had up to 5 treatments for it, including CDK4/6 inhibitors.My advanced cancer has a specific PIK3CA mutation.I have advanced breast cancer and have had up to 5 treatments for it.I have colorectal cancer.I have an advanced solid tumor and have had up to 5 treatments for it.I have advanced breast cancer and have had up to 5 treatments for it.I have stopped all cancer treatments and recovered from major side effects.I have an advanced solid tumor and have had up to 5 treatments for it.I have breast cancer with at least one bone lesion.You have a serious health condition.I have an advanced solid tumor and have had up to 3 treatments for it.I have not taken PI3K/AKT/mTOR inhibitors, or only under specific conditions.I have diabetes and take medication for it.I have a tumor outside the breast that can be measured.I have a stored tumor sample or have been approved without one.I have stopped all cancer treatments and recovered from major side effects.I have or might have untreated brain involvement.Patients must have a disease that can be measured.My blood tests show my organs are working well.My endometrial cancer has specific genetic changes.My breast cancer is ER+ and HER2- and I've had CDK4/6 inhibitor therapy.
- Group 1: Phase 1B: Part F
- Group 2: Phase 1B: Part A
- Group 3: Phase 1B: Part B
- Group 4: Phase 1B: Part C
- Group 5: Phase 1B: Part D
- Group 6: Phase 1A: LOXO-783 Monotherapy Dose Escalation
- Group 7: Phase 1B: Part E
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What key results is this trial seeking to achieve?
"During a 28-day period, this clinical trial aims to identify the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of LOXO-783. Secondary objectives include estimating its pharmacokinetics parameters such as area under concentration versus time curve and peak drug concentrations, plus assessing initial antitumor activity with duration of response metrics."
How many healthcare facilities in Canada are conducting this medical experiment?
"This clinical trial is open for enrolment at specific medical centres, such as Texas Oncology-Baylor Charles A. Sammons Cancer Center in Dallas, START in San Antonio and the Memorial Sloan Kettering Cancer Center in New york and Massachusetts. Additionally, there are 8 other sites available to prospective participants."
How many people are currently participating in this experiment?
"Affirmative. According to the information posted on clinicaltrials.gov, this trial is currently enrolling patients; it was first announced on May 11th 2022 and further updated November 11th of that same year. The research needs 300 participants from 8 different sites in order to be completed successfully."
Can you explain the potential risk of administering LOXO-783 to individuals?
"Since this is a Phase 1 trial, which suggests an absence of substantial clinical data corroborating safety or efficacy, LOXO-783 was assigned a score of 1."
Is it possible for new participants to join this medical experiment?
"Data hosted on clinicaltrials.gov verifies that this medical trial is actively seeking out participants. This research endeavour was first launched on May 11th 2022 and its details have been modified as of November 11th 2022."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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