Is NCT04557449 recruiting in New Haven, CT?

Yes, NCT04557449 is currently enrolling participants at its New Haven, CT location. This liposarcoma clinical trial is accepting qualified participants.

How do I join the liposarcoma clinical trial in New Haven?

To join this clinical trial in New Haven, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New Haven clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Liposarcoma Clinical Trial in New Haven, CT: PF-07220060 (Phase 1/2)

About This Liposarcoma Study in New Haven

This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and in combination with endocrine therapy. Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort. Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide. The Giredestrant Combination Cohort will evaluate PF-07220060 in combination with giredestrant. In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion. In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively). In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from Part 1A will be conducted. In Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI). In Part 1F, escalating doses of PF-07220060 will be administered in combination with enzalutamide. In Part 1G, PF-07220060 will be administered in combination with tamoxifen to determine the RDE. Part 2A is an expansion cohort for PF-07220060 in combination with fulvestrant and will explore more than one dose of PF-07220060. Part 2B and Part 2C are expansion cohorts for PF-07220060 in combination with letrozole and fulvestrant, respectively. Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy. Part 2F is an expansion cohort for PF-07220060 in combination with tamoxifen. The Giredestrant Combination Cohort Group A will determine the tolerable dose of PF-07220060 in combination with giredestrant. In Group B, additional participants will be enrolled at the tolerable dose to further assess safety and PK. The China and Japan monotherapy cohorts will evaluate safety, tolerability, and PK of PF-07220060 as single agent in Chinese and Japanese participants, respectively.

Sponsor: Pfizer

Who Can Participate

Inclusion Criteria

Part 1: Breast Cancer (BC)

Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) BC

Part 1A/Part 1D/Part 1E also include: Refractory HR-positive/HER2-positive BC

Part 1: Tumors other than BC (Part 1A/Part 1D/Part 1E): NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests

Part 1F: prostate cancer

Part 1G: HR-positive/HER2-negative BC

Part 2A, 2B, 2C, 2E, and 2F: HR-positive/HER2-negative BC

Part 1D: metastatic castration resistant prostate cancer

Giredestrant Combination Cohort: ER-positive/HER2-negative BC

Prior systemic Treatment

Part 1: HR-positive/HER2-negative BC

At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator

HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy

Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available

Part 2A and 2E: at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed

Part 2B: no prior systemic anti-cancer therapies for advanced/metastatic BC

Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or

Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal

One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy

Part 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy

Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy General Inclusion Criteria

All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

Adequate renal, liver, and bone marrow function

Exclusion Criteria

Part 2B: prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior treatment with any CDK4/6 inhibitor

Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway

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

Major surgery or radiation within 4 weeks prior to study intervention

Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4

Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry

Part 1G and 2F: history of or current pulmonary embolism or deep vein thrombosis

Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate \<50 bpm at screening

Pregnant or breastfeeding female participant

Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Haven?

Yes, this clinical trial (NCT04557449) has an active research site in New Haven, CT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Liposarcoma Treatment Options in New Haven, CT

If you're searching for liposarcoma treatment options in New Haven, CT, this clinical trial (NCT04557449) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Haven research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced liposarcoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all liposarcoma clinical trials near you to find additional studies recruiting in your area.

Liposarcoma Clinical Trial in New Haven, CT

Expert Care in New Haven

IRB Approved

No-Cost Care

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