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

Must not have

Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease

Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, PF-07220060, in patients with metastatic breast cancer. It aims to find the best dose and see if the drug helps stop cancer growth when used alone or with other treatments.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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.

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have active brain metastases or related conditions.

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I haven't had any cancer except for certain skin cancers or localized cancer that hasn't spread in the last 3 years.

Select...

I have previously been treated with medications targeting cancer cell growth.

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I have not had major surgery or radiation in the last 4 weeks.

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I have an active stomach or bowel disease, or I've had surgery on my stomach.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DDI

Food Effect

Incidence of clinically significant AEs

+3 more

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

17Treatment groups

Experimental Treatment

Group I: 2E Combination Dose ExpansionExperimental Treatment2 Interventions

PF-07220060 Monotherapy OR PF-07220060 plus fulvestrant combination therapy

Group II: 2D Combination Dose ExpansionExperimental Treatment2 Interventions

PF-07220060 with enzalutamide Combination Expansion

Group III: 2C Combination Dose ExpansionExperimental Treatment2 Interventions

PF-07220060 with fulvestrant Combination Expansion

Group IV: 2B Combination Dose ExpansionExperimental Treatment2 Interventions

PF-07220060 with Letrozole Combination Expansion

Group V: 2A Combination Dose ExpansionExperimental Treatment2 Interventions

PF-07220060 with fulvestrant combination dose expansion

Group VI: 1F Combination Dose FindingExperimental Treatment2 Interventions

PF-07220060 with Enzalutamide Escalation

Group VII: 1E DDI CohortExperimental Treatment2 Interventions

PF-07220060 DDI with Midazolam

Group VIII: 1D Monotherapy Food EffectExperimental Treatment1 Intervention

PF-07220060 Monotherapy Food Effect

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

PF-07220060 with Fulvestrant Combination Escalation

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

PF-07220060 with Fulvestrant Combination Escalation

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

PF-07220060 with Letrozole Combination Escalation

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

PF-07220060 with Letrozole combination Escalation

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