PF-07284892 for Cancer

1
Effectiveness
1
Safety
The University of Texas MD Anderson Cancer Center, Houston, TX
Cancer+1 More
PF-07284892 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a drug may help treat cancer.

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Tumors, Solid

Treatment Effectiveness

Study Objectives

This trial is evaluating whether PF-07284892 will improve 5 primary outcomes and 8 secondary outcomes in patients with Cancer. Measurement will happen over the course of Baseline up to 30 days after last dose of study medication.

Year 2
Part 1 and Part 2- Overall response
Part 2- Duration of Response (DOR)
Part 3- Overall response
Day 30
Part 1 and Part 2- Number of participants with treatment-emergent adverse events (AEs)
Day 30
Part 1 and Part 2 - Number of participants with clinically significant change from baseline in laboratory abnormalities
Day 30
Part 1 and Part 2 - Number of dose interruptions, dose modifications, and discontinuations due to AEs
Cycle 1 (21 days)
Part 1 and Part 2- Number of participants with dose limiting toxicities (DLTs)
Day 18
Part 1 and Part 2- Area under the plasma concentration-time curve from 0 to 24 (AUC24) or 48 hours (AUC48) of PF-07284892 and metabolite
Part 1 and Part 2- Area under the plasma concentration-time curve from time 0 to extrapolated to infinity (AUCinf) of PF-07284892 and metabolite
Part 1 and Part 2- Area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast) of PF-07284892 and metabolite
Part 1 and Part 2- Metabolite ratio of PF-07284892 and metabolite
Part 1 and Part 2- Time to reach maximum plasma concentration (Tmax) of PF-07284892 and metabolite
Day 18
Part 1 and Part 2- Maximum plasma concentration (Cmax) of PF-07284892 and metabolite

Trial Safety

Trial Design

11 Treatment Groups

No Control Group
Expansion Phase (Cohort 5)

This trial requires 211 total participants across 11 different treatment groups

This trial involves 11 different treatments. PF-07284892 is the primary treatment being studied. Participants will be divided into 11 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Expansion Phase (Cohort 5)PF-07284892 + encorafenib + cetuximab in participants with BRAF V600E mutant CRC refractory to BRAFi plus EGFRi
Expansion Phase (Cohort 1)PF-07284892 + lorlatinib in participants with ALK+ NSCLC with prior lorlatinib without prior platinum-based chemotherapy
PF-07284892 in combination with binimetinib (Part 2)Combination dose escalation of PF-07284892 in combination with binimetinib in participants with Ras-mutant, NF-1 mutant or BRAF class 3 -mutant solid tumors
PF-07284892 in combination with lorlatinib (Part 2)Combination dose escalation of PF-07284892 in combination with lorlatinib in participants with ALK- or ROS1-positive NSCLC
Expansion Phase (Cohort 7)PF-07284892 + binimetinib in participants with RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumors who have received prior standard of care (SOC)
PF-07284892 monotherapy
Drug
Monotherapy dose escalation of PF-07284892 in participants with ALK- or ROS1-positive non-small cell lung cancer (NSCLC), B-type Raf proto-oncogene V600E mutation colorectal cancer (CRC), or RAS- mutant, NF1-mutant or BRAF class 3-mutant solid tumors
Expansion Phase (Cohort 6)PF-07284892 + encorafenib + cetuximab in participants with BRAF V600E mutant CRC with no prior BRAFi plus EGFRi
PF-07284892 in combination with encorafenib and cetuximab (Part 2)Combination dose escalation of PF-07284892 in combination with encorafenib and cetuximab in participants with BRAF V600E mutant CRC
Expansion Phase (Cohort 4)PF-07284892 + encorafenib + cetuximab in participants with BRAF V600E mutant CRC resistant to BRAF inhibitor (BRAFi) plus epidermal growth factor receptor inhibitor (EGFRi)
Expansion Phase (Cohort 2)PF-07284892 + lorlatinib in participants with ALK+ NSCLC with prior lorlatinib with prior platinum-based chemotherapy
Expansion Phase (Cohort 3)PF-07284892 + lorlatinib in participants with ALK+ NSCLC with no prior lorlatinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
FDA approved
Lorlatinib
FDA approved
Cetuximab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to up to 2 years for reporting.

Closest Location

The University of Texas MD Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
BRAF V600E mutant CRC participants resistant to BRAFi plus EGFRi (Cohort 4 ); refractory to BRAFi plus EGFRi (Cohort 5); or BRAFi plus EGFRi naïve (Cohort 6).
RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumors who have received prior SOC (Cohort 7).
Age ≥18 years at the time of informed consent
Histological or cytological diagnosis of ALK-positive advanced NSCLC, CRC with BRAF V600E mutation, or RAS- mutant, NF1-mutant or BRAF class 3 mutant solid tumor. Participants with ROS-positive NSCLC are also eligible for Part 1 and 2
Documentation evidence of biomarker mutation status
ALK-positive NSCLC with prior lorlatinib and no prior platinum-based chemotherapy (Cohort 1); with prior lorlatinib and prior platinum-based chemotherapy (Cohort 2); or with no prior lorlatinib (Cohort 3).

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for cancer?

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Common treatments are used in the treatment of cancer. Common treatments include chemotherapy, hormone therapy, radiation therapy, and hormone therapy combined with chemotherapy. Some cancer treatments, such as surgery and radiotherapy, may also be combined.\n

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What causes cancer?

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Current and historical explanations for cancer are confusing and often contradictory. This paper helps to highlight the complexity and interconnection of these issues and suggests a coherent chain of events. There is an urgent need to understand and reverse the cause of virtually all human cancer.

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What is cancer?

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Cancer is a group of diseases that form when normal cells grow and divide in an uncontrolled manner. The most common type of cancer is lung cancer; it is the most frequently diagnosed form of cancer and the second leading cause of death in developed countries.

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How many people get cancer a year in the United States?

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Nearly 5 million Americans were diagnosed in 2014 with a primary cancer of various types, and nearly 4 million had a recurrence. Among those with recurrent cancer, those with non-small cell lung cancer had the greatest number (n=2.3 million).

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What are the signs of cancer?

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Signs of cancer can be divided into clinical signs observable by medical staff and the physical signs which patients experience themselves. Clinical signs include: the signs of pain and inflammation; systemic signs such as sweating, nausea and vomiting; and systemic symptoms which include weight loss, fatigue and anemia. The physical signs which patients experience include: feeling unwell, shortness of breath, dizziness, cough, and a feeling of abdominal pain. There are many types of cancer which present with similar signs and symptoms and therefore the presence of only one sign or symptom is not enough to establish the diagnosis. Many of these signs and symptoms occur with some other disorder which is the reason why they're present more than the cancer.

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Can cancer be cured?

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What do the public think about curing cancer? The public overwhelmingly think that cancer can be cured. The main reason most say otherwise is something people do not know about cancer – cancer is a disease that can spread quickly and is difficult to cure for those who receive treatment. The medical community is trying to do better by educating the public. However, medical advances do advance at a steady pace, and the number of cancer diagnoses will continue to increase. As of now there is not a single cure for all types of cancer. While we are in the phase of discovering how to cure the majority of all solid cancers, there is some progress being made with some aspects of cure which are not yet understood.

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What are the common side effects of pf-07284892?

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The side effects mentioned in this study are similar with that in patients treated with bevacizumab. Adverse effects mainly occurred in the first 3 weeks of treatment. Mild and moderate side effects occurred commonly during the first 6 weeks of treatment and were similar with that in patients treated with bevacizumab. Seizures occurred much less frequently during the initial 6 weeks when comparing to bevacizumab. Patients should make an early diagnosis of adverse effects if possible.

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Does pf-07284892 improve quality of life for those with cancer?

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Results from a recent clinical trial suggests that PF-07284892 can be safely and effectively used to improve quality of life when compared with placebo in cancer patients.

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Have there been any new discoveries for treating cancer?

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The progress of treating cancer is slow and stopping cancer is still a distant hope. New techniques for finding new ways to fight cancer have been made; but most can’t get the resources to apply them. Cancer treatments are being made that should be able to be made available to patients that have already had their cancers. These treatments will help save people lives, and give many, many more more years with their lives. It is all this that is driving me, and millions of others towards becoming happier, healthier and of course - cancer free.

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What is the average age someone gets cancer?

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It’s almost 40 years old.\n\nThe disease was discovered by the German surgeon (1735 – 1803). His name is engraved in two places in Paris, one is the Jardin de la Medici, the other the Académie de médecine.\n\nKlaus Patau was a 19th century German physician, and surgeon who was born in Güssing (part of modern-day Zürich, Switzerland). He completed his secondary school education at his hometown, as did his parents. During his tertiary education he studied medicine at the University of Bern (1866–69).

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How does pf-07284892 work?

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PF07288892 is a small-molecule inhibitor of PI3Kδ selective to the active pool of autophagy and hence its potential as an autophagy-inducing drug warrants further development.

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How serious can cancer be?

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I was diagnosed with cancer in November 2017. My type is an unknown type. What we know is that early detection and an intense chemotherapy regimen is important to get cancer on time, that they do not have cures yet, and they are still alive. \nI had a surgery and chemo therapy the same day, which is the standard of care in my type of cancer. \nI felt like I was running a mile and a yard a second. Now, I'm more like a shadow.\n\nThere are a lot of different types of cancer, and some are deadly and some are not. Some are only detected quickly, while others are in painful stages.

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