Your session is about to expire
← Back to Search
CDK4i Trial Summary
This trial is testing a new drug, PF-07220060, to see if it is safe and effective when used alone or in combination with other drugs. The trial will be conducted in four parts, with escalating doses in the first part to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). The second part of the trial will test the drug in combination with two different endocrine therapies (letrozole and fulvestrant). The third part of the trial will assess the food effect of the RP2D dose from Part 1A. The fourth part of the trial will be an expansion for combination
CDK4i Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCDK4i Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CDK4i Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I do not have active brain metastases or related conditions.I haven't had cancer treatment in the last 2 weeks.My breast cancer is HR+ and HER2- and does not respond to hormone therapy.My cancer returned while on or soon after aromatase inhibitor treatment. I've also had CDK4/6 inhibitor therapy.I haven't had any cancer except for certain skin cancers or localized cancer that hasn't spread in the last 3 years.My breast cancer is resistant to treatment and is both HR and HER2 positive.I have previously been treated with medications targeting cancer cell growth.My kidney, liver, and bone marrow are functioning well.My breast cancer is HR-positive and HER2-negative.I have a measurable cancer lesion on my skin or bone.My cancer can be measured by tests, and I may have cancer spread to bones but not just a rise in tumor markers.I have not had major surgery or radiation in the last 4 weeks.You have a visible and measurable tumor according to a specific set of rules called RECIST v1.1.I have prostate cancer.My condition hasn't improved with current treatments.I am fully active or restricted in physically strenuous activity but can do light work.I have an active stomach or bowel disease, or I've had surgery on my stomach.I cannot fast overnight or eat a high-fat, high-calorie meal due to surgery or dietary restrictions.My cancer is NSCLC, prostate, CRC, liposarcoma, or has CDK4/CCND1 amplification.My breast cancer is HR-positive and HER2-negative.My prostate cancer has spread and is not responding to hormone therapy.
- Group 1: 1C Combination Dose Finding Arm 2
- Group 2: 1A Monotherapy Escalation Arm 2
- Group 3: 1B Combination Dose Finding Arm 1
- Group 4: 2C Combination Dose Expansion
- Group 5: 1D Monotherapy Food Effect
- Group 6: 1F Combination Dose Finding
- Group 7: 1E DDI Cohort
- Group 8: 2D Combination Dose Expansion
- Group 9: 2A Combination Dose Expansion
- Group 10: 2B Combination Dose Expansion
- Group 11: 1A Monotherapy Escalation Arm 3
- Group 12: 1A Monotherapy Escalation Arm 4
- Group 13: 1B Combination Dose Finding Arm 2
- Group 14: 1A Monotherapy Escalation Arm 1
- Group 15: 1A Monotherapy Escalation Arm 5
- Group 16: 1C Combination Dose Finding Arm 1
- 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
Are there still opportunities to take part in this medical trial?
"Affirmative. According to the records on clinicaltrials.gov, this trial is actively recruiting participants after being posted in September 2020 and most recently updated in January 2022. 118 candidates must be sourced from 9 different medical facilities for successful completion of the study."
What prior research has been conducted related to PF-07220060?
"PF-07220060 first saw clinical trials in 1995 at the National Institutes of Health Clinical Center, with a total of 268 studies having been completed. As of present day, 251 active experiments are underway across multiple sites - notably Nashville, Tennessee."
Does the experimental protocol permit individuals over 30 to participate?
"Those wishing to participate must be aged 18-99 years old. The database of clinical trials indicates 181 studies for minors and 3750 trials available to the elderly population."
What are the targeted effects of this research?
"This study's primary goal is to evaluate the incidence of clinically meaningful adverse events occurring within a 28 day period at baseline. Secondary objectives include assessing area under the plasma concentration versus time curve, tumor response per RECIST v1.1 and terminal elimination half-life in regards to PF-07220060 when administered as an escalating/finding dose (Parts 1A, 1B, 1C)."
What is the typical purpose of administering PF-07220060?
"PF-07220060 is an efficacious treatment for progression, disease, tamoxifen and postmenopause."
Has the FDA sanctioned PF-07220060 for use?
"The safety of PF-07220060 was assessed with a score of 1 given its phase 1 status, which implies that there is some preliminary data verifying efficacy and limited safety testing."
Who is eligible to volunteer for this clinical experiment?
"This medical trial seeks 118 individuals between the ages of 18 and 99 with a confirmed diagnosis of breast cancer. The ideal candidates should meet these criteria: Part 1A/Part 1D – Non-Small cell lung cancer, Prostate cancer, Colorectal cancer, Liposarcoma or any tumor exhibiting CDK4 or CCND1 amplification; Part 2 – measurable lesion per RECIST v1.1 parameters; Postmenopausal women (or pre/peri-menopausal in Part 2C only); Evaluable lesions including skin or bone lesions."
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger