What side effects are associated with this type of intervention?

Common treatments for liposarcoma, such as doxorubicin, ifosfamide, and cisplatin, are associated with side effects including myelosuppression, nausea, vomiting, fatigue, and nephrotoxicity. Doxorubicin can cause cardiotoxicity, ifosfamide may lead to neurotoxicity and hemorrhagic cystitis, and cisplatin is known for ototoxicity and peripheral neuropathy. Novel agents like PF-07220060, currently under study, may have unique side effects that are still being evaluated.

What prior FDA approvals exist?

Pazopanib has been FDA-approved for the treatment of advanced soft tissue sarcoma, including liposarcoma, after prior chemotherapy. It is a tyrosine kinase inhibitor that targets multiple receptors involved in tumor growth and angiogenesis. Another treatment option is trabectedin, which has shown activity in advanced soft tissue sarcomas. These treatments are relevant as they target pathways that could be similar to those being investigated in new trials like PF-07220060.

What other types of research exist?

Promising novel alternatives to PF-07220060 for Liposarcoma patients include S 16020-2, which has shown superior antitumor activity in various models, and LY181984, which has demonstrated significant inhibition of tumor growth and metastasis in preclinical studies. Both agents exhibit broad-spectrum antitumor efficacy and potential for treating solid tumors.

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PF-07220060 for Solid Cancers (CDK4i Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Part 1: Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Breast Cancer (BC)

Prior systemic Treatment: Part 1: HR-positive/HER2-negative BC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 24 months

Awards & highlights

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

Who is the study for?

This trial is for adults with advanced solid tumors, including specific breast and prostate cancers, who have not responded to existing therapies. Participants must have a certain level of physical fitness (ECOG PS 0 or 1) and adequate organ function. They should not have received cancer treatment within the last 2 weeks or be pregnant/breastfeeding.Check my eligibility

What is being tested?

The study tests PF-07220060's safety and effects both alone and with endocrine therapy in multiple doses. It includes patients with various cancers such as lung adenocarcinoma, colorectal cancer, liposarcoma, prostate cancer, and breast cancer.See study design

What are the potential side effects?

As this is an early-phase trial testing PF-07220060's safety, potential side effects are being studied but may include typical reactions like nausea, fatigue, allergic responses or more serious ones depending on individual patient factors.

CDK4i Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is HR+ and HER2- and does not respond to hormone therapy.

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My breast cancer is HR-positive and HER2-negative.

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I have a measurable cancer lesion on my skin or bone.

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My condition hasn't improved with current treatments.

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

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My cancer is NSCLC, prostate, CRC, liposarcoma, or has CDK4/CCND1 amplification.

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My prostate cancer has spread and is not responding to hormone therapy.

CDK4i Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

DDI

Food Effect

Incidence of clinically significant AEs

+3 more

Secondary outcome measures

Apparent Oral Plasma Clearance (CL/F) in the Dose Escalation and Dose Finding portion

Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCss,t) in the Dose Escalation and Dose Finding portion

Clinical Benefit Rate (CBR)

+22 more

CDK4i Trial Design

16Treatment groups

Experimental Treatment

Group I: 2D Combination Dose ExpansionExperimental Treatment2 Interventions

PF-07220060 with enzalutamide Combination Expansion

Group II: 2C Combination Dose ExpansionExperimental Treatment2 Interventions

PF-07220060 with fulvestrant Combination Expansion

Group III: 2B Combination Dose ExpansionExperimental Treatment2 Interventions

PF-07220060 with Letrozole Combination Expansion

Group IV: 2A Combination Dose ExpansionExperimental Treatment2 Interventions

PF-07220060 with fulvestrant combination dose expansion

Group V: 1F Combination Dose FindingExperimental Treatment2 Interventions

PF-07220060 with Enzalutamide Escalation

Group VI: 1E DDI CohortExperimental Treatment2 Interventions

PF-07220060 DDI with Midazolam

Group VII: 1D Monotherapy Food EffectExperimental Treatment1 Intervention

PF-07220060 Monotherapy Food Effect

Group VIII: 1C Combination Dose Finding Arm 2Experimental Treatment2 Interventions

PF-07220060 with Fulvestrant Combination Escalation

Group IX: 1C Combination Dose Finding Arm 1Experimental Treatment2 Interventions

PF-07220060 with Fulvestrant Combination Escalation

Group X: 1B Combination Dose Finding Arm 2Experimental Treatment2 Interventions

PF-07220060 with Letrozole Combination Escalation

Group XI: 1B Combination Dose Finding Arm 1Experimental Treatment2 Interventions

PF-07220060 with Letrozole combination Escalation

Group XII: 1A Monotherapy Escalation Arm 5Experimental Treatment1 Intervention