Study on PF-07104091 as a Single Treatment and in Combination for Advanced Cancers
Sponsor: Pfizer
ClinicalTrials ID:NCT04553133
This clinical trial is testing the safety and best dose of a new drug, PF-07104091, for treating advanced or metastatic small cell lung, breast, and ovarian cancers. The study aims to find the most effective dose for future research.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and tolerability of increasing doses of PF-07104091 in patients with advanced or metastatic small cell lung cancer, breast cancer, and ovarian cancer. The study will determine the highest dose that can be given safely and select the best dose for further research.
Description
This study, known as C4161001, is a Phase 1 trial that is open to adults with advanced or metastatic cancers, including small cell lung cancer, ovarian cancer, and breast cancer. The trial will test different doses of PF-07104091 to find the safest and most effective dose. The study is divided into two parts: Part 1 will focus on finding the safest dose, and Part 2 will establish the recommended dose for future studies. Participants will receive multiple doses of the drug and will be monitored for safety and how their bodies process the drug.
Eligibility Criteria
Inclusion Criteria
- Have advanced or metastatic breast cancer that is HR-positive and HER2-negative, and have received at least two prior treatments, including a CDK4/6 inhibitor and endocrine therapy.
- Have advanced or metastatic triple negative breast cancer (TNBC) and have received up to two prior chemotherapy treatments.
- Have advanced ovarian cancer that is resistant to platinum-based treatments and have received at least one prior treatment.
- Have advanced or metastatic small cell lung cancer (SCLC).
- Have advanced or metastatic non-small cell lung cancer (NSCLC).
- Have at least one measurable tumor that has not been treated with radiation.
- Be in good overall health with a performance status of 0 or 1.
- Have adequate bone marrow, blood, kidney, and liver function.
- Have recovered from any side effects of previous treatments.
Exclusion Criteria
- Have brain metastases that require steroids.
- Have another active cancer within the past three years.
- Have had major surgery within three weeks before starting the study.
- Have had radiation therapy within three weeks before starting the study.
- Have had other cancer treatments within four weeks before starting the study.
- Have had radiation to more than 25% of the bone marrow.
- Have active infections, including hepatitis B, hepatitis C, or HIV.
- Have an active COVID-19 infection.
- Have heart problems or abnormal ECG results that could affect safety.
- Have had serious heart or blood vessel problems in the past six months.
- Are taking blood thinners that are not allowed in the study.
- Have high blood pressure that cannot be controlled with medication.
- Are participating in another clinical trial with investigational drugs.
- Have allergies to the study drug or its ingredients.
- Have digestive issues or previous stomach surgeries that could affect the study.
- Have advanced cancer with symptoms that could lead to life-threatening complications.
- Have an external catheter for drainage or central venous access.
- Have had high-dose chemotherapy requiring stem cell rescue.
- Have bleeding disorders or are taking anticoagulants that prevent certain injections.
- Are taking medications that affect how the body processes drugs.
- Have a positive pregnancy test at screening.
- Have other medical or psychiatric conditions that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Medical Oncology & Hematology Associates DBA Mission Cancer and Blood | 50325 | Clive | Iowa |
| Des Moines Oncology Research Association | 50309 | Des Moines | Iowa |
| Medical Oncology & Hematology Associates DBA Mission Cancer and Blood | 50309 | Des Moines | Iowa |
| Medical Oncology & Hematology Associates DBA Mission Cancer and Blood | 50314 | Des Moines | Iowa |
| Norton Hospital | 40202 | Louisville | Kentucky |
| Norton Cancer Institute, St. Matthews Campus | 40207 | Louisville | Kentucky |
| Norton Cancer Institute, Audubon | 40217 | Louisville | Kentucky |
| Norton Brownsboro Hospital | 40241 | Louisville | Kentucky |
| Norton Cancer Institute, Brownsboro Campus | 40241 | Louisville | Kentucky |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
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