What Is PF-06747775?
PF-06747775 is an investigational medication currently being studied for its potential role in treating certain cancers. It is being developed as a treatment for advanced Non-Small Cell Lung Cancer (NSCLC) that has specific epidermal growth factor receptor (EGFR) mutations. This drug is designed to act as a targeted therapy, aiming to interfere with the growth and spread of cancer cells that carry these particular mutations. By targeting the EGFR pathway, PF-06747775 seeks to provide a more precise approach to cancer treatment compared to traditional chemotherapy.
The medication is being evaluated in clinical trials both as a single agent and in combination with other existing cancer treatments. The overall clinical study includes a Phase 1 dose-escalation and expansion part. This initial phase aims to determine the recommended Phase 2 dose (RP2D) of PF-06747775 when used alone in patients with previously-treated EGFRm NSCLC. Subsequent evaluations will then assess PF-06747775 at this determined RP2D, both as a single agent and in combination with other therapies. This research helps to understand the drug's safety, effectiveness, and optimal dosing strategy for patients with this specific type of advanced lung cancer.
Uses and Conditions Under Study
PF-06747775 is currently under investigation for the treatment of Non-Small Cell Lung Cancer (NSCLC). NSCLC is the most common type of lung cancer, accounting for about 85% of all lung cancer diagnoses. In particular, PF-06747775 is being studied in patients with advanced NSCLC who have specific epidermal growth factor receptor (EGFR) mutations. These mutations can drive the growth and spread of cancer cells.
This investigational drug is designed to specifically target these EGFR mutations, aiming to block the signals that promote cancer cell growth. By inhibiting these pathways, PF-06747775 may help to slow or stop the progression of the disease. The clinical development program for PF-06747775 includes a Phase 1/2 study that is evaluating the drug both as a single agent and in combination with other cancer treatments. This study aims to identify the optimal dose and assess the safety and efficacy of PF-06747775 in patients whose EGFRm NSCLC has been previously treated.
Currently, PF-06747775 has been studied in one clinical trial involving 65 participants for Non-Small Cell Lung Cancer. This trial began on January 29, 2015, and is no longer recruiting new participants. The research conducted by the sponsor, Pfizer, focuses on understanding the drug's potential benefits for patients with this specific type of advanced lung cancer.
Dosing
Information regarding the specific dosage forms and strengths of PF-06747775 is not fully detailed in the publicly available trial data. The clinical study for PF-06747775 involves a dose-escalation phase, which means that participants receive increasing doses of the medication to determine the safest and most effective amount. The study design refers to different treatment groups or dose levels as Cohort 1, Cohort 2A, Cohort 2B, and Cohort 3. These cohorts likely represent different dosages or treatment regimens being investigated.
The primary goal of the Phase 1 part of the study is to determine the recommended Phase 2 dose (RP2D) of PF-06747775 as a single agent. This RP2D is the dose that will be further evaluated in later stages of the clinical trial for its efficacy and safety. Specific details about whether PF-06747775 is administered as a tablet, capsule, or another form, or how frequently it is taken (e.g., once daily, twice daily), are not provided in the current data. As an investigational drug, the exact dosing regimen will be finalized based on the results of ongoing and future clinical trials.
Side Effects
Detailed frequencies of specific side effects and comparisons to a placebo group are not available in the provided clinical trial data for PF-06747775. The information below reflects the number of participants who experienced general categories of adverse events across different study cohorts.
In the group of participants receiving PF-06747775 200 mg once daily, 29 participants experienced treatment-emergent adverse events (all causes), and 7 participants experienced treatment-related adverse events. Serious adverse events were reported in 1 participant and 3 other participants (likely representing different types of serious events) in this group.
For participants receiving PF-06747775 200 mg once daily in combination with Palbociclib 100 mg once daily (Phase 1b Cohort 2A), 2 participants experienced dose-limiting toxicities during the first two cycles. In this combination group, 5 participants experienced treatment-emergent adverse events (all causes), and 5 participants experienced treatment-related adverse events. Serious adverse events were reported in 1 participant and 1 other participant (likely different types of serious events).
Regarding potential heart rhythm changes, 1 participant in the PF-06747775 200 mg QD Group and 1 participant in the PF-06747775 25 mg
Currently Recruiting Trials
Currently, there are no active clinical trials recruiting participants for PF-06747775. This means that all studies involving this investigational drug are either completed, paused, or not currently seeking new volunteers. Patients interested in PF-06747775 should consult their healthcare provider for the latest information on its development status and any potential future opportunities for participation. Information regarding past trials and the drug's development history can be found in the sections below.
Where to Participate
As there are currently no active clinical trials recruiting for PF-06747775, there are no specific study sites or locations available for participation at this time. When trials for PF-06747775 were conducted, specific eligibility criteria were in place to ensure participant safety and study integrity. These criteria generally allowed for participants of all genders to be considered. Healthy volunteers were typically not included, meaning studies focused on individuals with specific medical conditions. Additionally, children were excluded from participation in these trials, indicating that the studies were designed for adult populations.
Development Timeline
The clinical development journey for PF-06747775 began on January 29, 2015, with the initiation of its first recorded clinical trial. This single study, sponsored by Pfizer, was designed as a combined Phase 1/Phase 2 investigation. It aimed to assess both the safety and initial efficacy of the drug. The trial successfully enrolled 65 participants, contributing valuable data to the understanding of PF-06747775.
The initial focus for PF-06747775 was on treating conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Based on the available data, the recorded timeline for trials involving PF-06747775 appears to be contained within this single day, indicating a specific period of trial activity or data reporting. The progression through a combined Phase 1/Phase 2 study is a critical early milestone, providing foundational insights into a new investigational medicine.