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PF-07265807 for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Community Health Network Cancer Center North, Indianapolis, INCancerPF-07265807 - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing a new drug for safety and how well it works in people with advanced cancer.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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PF-07062119

Study Objectives

6 Primary · 45 Secondary · Reporting Duration: Baseline through approximately 2 years

Year 2
Disease Control Rate
Duration of Response
Part 4, Cohort 4: Complete Response (CR)
Part 4: Complete Response (CR)
Part 4: Number of participants with laboratory abnormalities
Part 4: Number of participants with treatment emergent AEs
Part 4: Overall Response Rate (ORR)
Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)
Parts 1, 2, and 3: Number of participants with laboratory abnormalities
Parts 1, 2, and 3: ORR
Progression Free Survival
Day 21
Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs)
Day 21
Part 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of axitinib
Part 3: Maximum plasma concentration at steady state (Cmax,ss) of axitinib
Part 3: Time to reach maximum plasma concentration at steady state (Tmax,ss) of axitinib
Day 21
Part 4, Cohort 4: Trough concentration (Ctrough) of axitinib
Day 21
Immunogenicity of sasanlimab when given in combination
Day 21
Part 4, Cohort 4: Axitinib PK concentration
Day 21
Part 4: Post dose concentration (Cmax) of PF-07265807 and its metabolite
Part 4: Trough concentration (Ctrough) of PF-07265807 and its metabolite
Day 21
Parts 1, 2, and 3: Apparent oral clearance (CL/F) of PF-07265807
Parts 1, 2, and 3: Apparent terminal volume of distribution (Vz/F) of PF-07265807
Parts 1, 2, and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of PF-07265807 and its metabolite
Parts 1, 2, and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of PF-07265807 and its metabolite
Parts 1, 2, and 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of PF-07265807 and its metabolite
Parts 1, 2, and 3: Maximum plasma concentration (Cmax) of PF-07265807 and its metabolite
Parts 1, 2, and 3: Terminal elimination half-life (t1/2) of PF-07265807 and its metabolite
Parts 1, 2, and 3: Time to reach maximum plasma concentration (Tmax) of PF-07265807 and its metabolite
Day 21
Parts 1, 2, and 3: Accumulation ratio area under the curve (Rac,auc) and of maximum observed concentration (Rac,cmax)
Parts 1, 2, and 3: Apparent oral clearance (CL/F)
Parts 1, 2, and 3: Apparent terminal volume of distribution (Vz/F)
Parts 1, 2, and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) and dose normalized (AUCinf(dn))
Parts 1, 2, and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) and dose normalized (AUClast(dn))
Parts 1, 2, and 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) and dose normalized (AUCtau(dn))
Parts 1, 2, and 3: Average observed concentration (Cavg)
Parts 1, 2, and 3: Maximum plasma concentration (Cmax) and dose normalized (Cmax(dn))
Plasma
Parts 1, 2, and 3: Terminal elimination half-life (t1/2)
Parts 1, 2, and 3: Time to reach maximum plasma concentration (Tmax)
Day 21
Pyruvate Kinase
Part4: PF-07265807 and its metabolite Pharmacokinetic (PK) concentration
Day 21
Part 4, Cohorts 2, 3 and 4: Trough concentration (Ctrough) of sasanlimab
Day 21
Part 4, Cohorts 2-4: Sasanlimab PK concentration
Year 1
Parts 2 and 3: Apparent clearance (CL/F) of sasanlimab
Parts 2 and 3: Apparent terminal volume of distribution (Vz/F) of sasanlimab
Parts 2 and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of sasanlimab
Parts 2 and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of sasanlimab
Parts 2 and 3: Maximum plasma concentration (Cmax) of sasanlimab
Parts 2 and 3: Terminal elimination half-life (t1/2) of sasanlimab
Parts 2 and 3: Time to reach maximum plasma concentration (Tmax) of sasanlimab
Parts 2, 3, and 4 Cohorts 2-4: Immunogenicity of sasanlimab when given in combination

Trial Safety

Safety Progress

1 of 3

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1
BIIB132
1
PF-07284890
1
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Side Effects for

Axitinib
30%Mucositis
10%Rash
10%nausea
10%Fatigue
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT02129647) in the Axitinib ARM group. Side effects include: Mucositis with 30%, Rash with 10%, nausea with 10%, Fatigue with 10%.

Trial Design

7 Treatment Groups

Triplet Dose Escalation: Part 3
1 of 7
Monotherapy Dose Escalation: Part 1
1 of 7
Doublet Dose Escalation: Part 2
1 of 7
Expansion Phase: Part 4, Cohort 1
1 of 7
Expansion Phase: Part 4, Cohort 2
1 of 7
Expansion Phase: Part 4, Cohort 3
1 of 7
Expansion Phase: Part 4, Cohort 4
1 of 7

Experimental Treatment

161 Total Participants · 7 Treatment Groups

Primary Treatment: PF-07265807 · No Placebo Group · Phase 1

Triplet Dose Escalation: Part 3Experimental Group · 3 Interventions: PF-07265807, Sasanlimab, Axitinib · Intervention Types: Drug, Drug, Drug
Monotherapy Dose Escalation: Part 1
Drug
Experimental Group · 1 Intervention: PF-07265807 · Intervention Types: Drug
Doublet Dose Escalation: Part 2Experimental Group · 2 Interventions: PF-07265807, Sasanlimab · Intervention Types: Drug, Drug
Expansion Phase: Part 4, Cohort 1
Drug
Experimental Group · 1 Intervention: PF-07265807 · Intervention Types: Drug
Expansion Phase: Part 4, Cohort 2Experimental Group · 2 Interventions: PF-07265807, Sasanlimab · Intervention Types: Drug, Drug
Expansion Phase: Part 4, Cohort 3Experimental Group · 2 Interventions: PF-07265807, Sasanlimab · Intervention Types: Drug, Drug
Expansion Phase: Part 4, Cohort 4Experimental Group · 3 Interventions: PF-07265807, Sasanlimab, Axitinib · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axitinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through approximately 2 years

Who is running the clinical trial?

PfizerLead Sponsor
4,355 Previous Clinical Trials
7,175,491 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,310 Previous Clinical Trials
4,837,349 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 14 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must have recovered from any side effects of a previous treatment.
You are expected to live for at least three more months.
You have tried standard treatments for your specific type of cancer but they didn't work or caused too many side effects.
References

Frequently Asked Questions

Does this experimental trial break new ground?

"Since 2011, scientific research has been conducted on PF-07265807. Initially backed by Pfizer in 2011, the drug was granted Phase 2 approval after a study of 39 participants. Currently there are 48 active studies for this medication reaching 30 countries and over 386 cities worldwide." - Anonymous Online Contributor

Unverified Answer

Have any other trials utilized PF-07265807 as a therapeutic measure?

"Currently, 48 studies are being conducted on the medication PF-07265807. Of these experiments, 4 of them have achieved Phase 3 status. Although the majority of trials for this drug take place in Houston, Texas there exist 1038 locations conducting research worldwide." - Anonymous Online Contributor

Unverified Answer

Does PF-07265807 pose any potential dangers to individuals?

"Our assessment of PF-07265807's safety is 1, as this initial trial has only a minimal amount of data to support its effectiveness and overall security." - Anonymous Online Contributor

Unverified Answer

How many sites have been selected for this experiment's implementation?

"Highlands Oncology Group in Rogers, Arkansas, Community Health Network Cancer Center North in Fayetteville, Indiana and Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus in Indianapolis are just some of the places conducting this trial. An additional 27 medical centres also participate." - Anonymous Online Contributor

Unverified Answer

What is the main purpose of this clinical trial?

"The overall aim of this research project, which will be monitored over a two-year Baseline period, is to discover the dose limiting toxicities associated with PF-07265807. Additionally, we also hope to uncover Single and multiple plasma concentration (Cmin), maximum plasma concentrations (Cmax) and its related normalized values (Cmax(dn)), as well as area under the curve from time of initial dosing till last measurable concentrations (AUClast/ AUClast(dn))." - Anonymous Online Contributor

Unverified Answer

How many people have signed up for participation in this clinical trial?

"Confirmed, the clinical trial's information hosted on clinicaltrials.gov states that enrollment is currently open. Originally posted on September 24th 2020, it was most recently updated on November 8th 2022 and seeks to recruit 161 individuals from 27 medical centres." - Anonymous Online Contributor

Unverified Answer

Is this research project currently accepting participants?

"That is correct. The information posted on clinicaltrials.gov demonstrates that this medical trial, first announced on September 24th 2020, is currently recruiting patients. 161 participants are needed from 27 different locations." - Anonymous Online Contributor

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

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