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Study Summary
This trial is testing a new drug to see if it is safe and how well it works against different types of cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My cancer is small cell lung cancer and has spread.I cannot take certain injections due to bleeding disorders or being on blood thinners.I have TNBC and received up to 2 chemotherapy treatments for advanced cancer.A pregnancy test shows that you are pregnant at the time of screening.I currently have COVID-19.I have not had serious heart or blood clot issues in the last 6 months.My lung cancer has spread to other parts of my body.I have brain metastases and need steroids for symptoms.I do not have any active, uncontrolled infections including HBV, HCV, HIV, or AIDS.My breast cancer is HR-positive, HER2-negative, and has spread.I am using or might need drugs sensitive to UGT1A1 with strict dosage requirements.My cancer has spread to other organs and is causing symptoms that could be life-threatening soon.I have ovarian, fallopian tube, or peritoneal cancer that didn't respond to platinum-based treatment.I have not had major surgery in the last 3 weeks.My heart's electrical activity is normal as per my last ECG.I have a tumor that can be measured and hasn't been treated with radiation.My blood, kidney, and liver tests are within normal ranges.You have a catheter with an external part for draining fluid or a central venous catheter with an external component.I haven't had any cancer treatments in the last 4 weeks.I have had high dose chemotherapy with stem cell support.Any other health or mental condition.I am fully active or restricted in physically strenuous activity but can do light work.I am not taking blood thinners like warfarin or Xarelto.I have not had any other cancer in the last 3 years.More than a quarter of my bone marrow has been exposed to radiation.My high blood pressure cannot be managed with medication.I have not had radiation therapy in the last 3 weeks.You have a known or suspected allergy to the active ingredient or other ingredients in PF 07104091.Any side effects from my previous treatments have gone away.I am not using, nor do I plan to use, strong drugs that affect liver enzymes.I have ongoing stomach or bowel issues, including surgeries.My breast cancer is HR-positive, HER2-negative, and I've had specific previous treatments.
- Group 1: PF-07104091 monotherapy dose expansion (ovarian)
- Group 2: PF-07104091 + fulvestrant (post CDK4/6) dose expansion
- Group 3: PF-07104091 + fulvestrant (post CDK 4/6) dose escalation
- Group 4: PF-07104091 + palbociclib + fulvestrant
- Group 5: PF-07104091 + palbociclib + letrozole
- Group 6: PF-07104091
- Group 7: PF-07104091 monotherapy dose expansion (SCLC)
- 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
How widespread is the availability of this research endeavor?
"Right now, this medical study is accepting participants across 22 locations. These include Louisville, Middletown and Houston - as well as other local centres. Prospective patients should consider the nearest site to reduce transport needs if they join the trial."
What is the upper limit of participants in this medical study?
"In order to adequately assess the efficacy of this treatment, we need 240 volunteers who meet all specified requirements. For those interested in taking part, research can be conducted at two different locations: Dana Farber Cancer Institute located in Louisville, Kentucky and Norton Diagnostic Center - Fern Creek situated in Middletown New jersey."
What illnesses is PF-07104091 monotherapy dose expansion (ovarian) typically used to alleviate?
"Progression-disease is usually managed with the use of PF-07104091 monotherapy dose expansion (ovarian). Besides this, tamoxifen, postmenopause and advance directives can all be treated by employing the same pharmacological approach."
Are there other experiments that have tested the efficacy of PF-07104091 monotherapy dose expansion (ovarian)?
"Presently, 334 clinical studies are researching PF-07104091 monotherapy dose expansion (ovarian). Of those, 68 currently reside in Phase 3. Remarkably, these trials have expanded to 18632 locations worldwide with the majority of research based out of Shanghai."
Are researchers presently collecting data for this trial?
"Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting participants and was initially posted on the 16th of September 2020, with its most recent update occurring on April 26th 2022. The research requires 240 individuals who are located in 22 different sites."
What aims does this research endeavor seek to accomplish?
"According to Pfizer, the study's primary efficacy measure is tracking treatment-associated adverse events and laboratory results occurring over a two year period. Secondary endpoints of interest include peak plasma concentrations with or without food consumption, time taken for drug absorption after both single and multiple doses, as well as signs of antitumor activity in combination with palbociclib and letrozole which will be judged based on RECIST 1.1 criteria."
Has the FDA approved PF-07104091 as a single drug dose for ovarian treatment?
"Our team has assigned a rating of 2 to the safety profile of PF-07104091 monotherapy dose expansion (ovarian), as clinical data supporting efficacy is still lacking despite some evidence for its safety."
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