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A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors.

Primary Purpose

Melanoma, Colorectal Cancer, Non-Small-Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PF-07799933
binimetinib
cetuximab
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

This study is seeking participants who meet the following eligibility criteria:

Inclusion Criteria:

  • Diagnosis of advanced/metastatic solid tumor including primary brain tumor.
  • Qualifying BRAF alteration (V600 or non-V600 Class II/Class III BRAF alteration), in tumor tissue and/or blood (ie circulating tumor deoxyribonucleic acid [DNA], or ctDNA).
  • Disease progressed during/following last prior treatment and no satisfactory alternative treatment options (Part 1 and Part 2).
  • Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies

Exclusion Criteria:

  • Brain metastasis larger than 4 cm
  • Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.
  • For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)

Sites / Locations

  • Highlands Oncology GroupRecruiting
  • Highlands Oncology GroupRecruiting
  • Highlands Oncology GroupRecruiting
  • Clinical And Translational Research CenterRecruiting
  • UCHealth Sue Anschutz-Rodgers Eye CenterRecruiting
  • University of Colorado Anschutz Medical CampusRecruiting
  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)Recruiting
  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)Recruiting
  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)Recruiting
  • University of Miami Hospital and Clinics, Sylvester Cancer Center
  • Brigham and Women's HospitalRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • DFCI Chestnut HillRecruiting
  • Brigitte Harris Cancer PavilionRecruiting
  • Henry Ford HospitalRecruiting
  • Henry Ford Medical Center - ColumbusRecruiting
  • MSK David H. Koch Center for Cancer CareRecruiting
  • Memorial Sloan Kettering Cancer Center 53rd streetRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Providence Cancer Institute Franz ClinicRecruiting
  • Providence Portland Medical CenterRecruiting
  • Sarah Cannon Research Institute - PharmacyRecruiting
  • Tennessee Oncology PLLCRecruiting
  • Tennessee Oncology, PLLCRecruiting
  • TriStar Bone Marrow TransplantRecruiting
  • TriStar Centennial Medical Center - Cell Processing LabRecruiting
  • TriStar Centennial Medical centerRecruiting
  • South Texas Accelerated Research Therapeutics (START)Recruiting
  • Cross Cancer Institute
  • The Ottawa Hospital - General CampusRecruiting
  • Princess Margaret Cancer Centre
  • McGill University Health CentreRecruiting
  • Rabin Medical Center
  • Sourasky Medical Center
  • Hadassah Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Monotherapy dose escalation (Part 1)

Combination dose escalation (Part 2)

Dose expansion (Part 3) - Tumor and mutation specific Cohort 1

Dose expansion (Part 3) - Tumor and mutation specific Cohort 2

Dose expansion (Part 3) - Tumor and mutation specific Cohort 3

Dose expansion (Part 3) - Tumor and mutation specific Cohort 4

Dose expansion (Part 3) - Tumor and mutation specific Cohort 5

Dose expansion (Part 3) - Basket Cohort 6

Arm Description

Participants will receive PF-07799933

Participants will receive PF-07799933 in combination with binimetinib or cetuximab

Participants will receive PF-07799933

Participants will receive PF-07799933 in combination with binimetinib

Participants will receive PF-07799933

Participants will receive PF-07799933 in combination with cetuximab

Participants will receive PF-07799933 in combination with cetuximab

Participants will receive PF-07799933 in combination with binimetinib or cetuximab

Outcomes

Primary Outcome Measures

Number of participants with dose limiting toxicities (DLTs) (Part 1 and Part 2)
DLTs will be evaluated during the first cycle (21 days) as both a single agent or in combination with binimetinib or cetuximab
Number of participants with treatment-emergent adverse events (AEs) (Part 1 and Part 2)
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Number of participants with clinically significant change from baseline in laboratory abnormalities (Part 1 and Part 2)
Laboratory abnormalities as characterized by type, frequency, severity, and timing
Number of participants with clinically significant change from baseline in vital sign abnormalities (Part 1 and Part 2)
Vital sign abnormalities as characterized by type, frequency, severity, and timing
Dose interruptions due to AEs (Part 1 and Part 2)
Incidence of dose interruptions due to AEs
Dose dose modifications due to AEs (Part 1 and Part 2)
Incidence of dose modifications due to AEs
Discontinuations due to AEs (Part 1 and Part 2)
Incidence of discontinuations due to AEs
MTD (Part 1 and Part 2)
Maximum tolerated dose (MTD)
RDE (Part 1 and Part 2)
Recommended dose for expansion (RDE)
Overall response rate (ORR) (Part 3)
Response will be evaluated via radiographical tumor assessments by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Number of participants with clinically significant physical exam abnormalities (Part 1 and Part 2)
Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Secondary Outcome Measures

Part 1 and Part 2: ORR
ORR as assessed using the RECIST version 1.1.
Part 1/2/3: Intracranial response
Intracranial response by RECIST version 1.1 (for brain metastases) & Response Assessment in Neuro-Oncology (RANO) - for primary brain tumors).
Part 1 and Part 2: Duration of response
Duration of response
Part 3: Number of participants with treatment-emergent adverse events (AEs)
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Part 3: Number of participants with clinically significant change from baseline in laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity, and timing
Part 3: Number of participants with clinically significant change from baseline in vital sign abnormalities
Vital sign abnormalities as characterized by type, frequency, severity, and timing
Part 3: Dose interruptions due to AEs
Incidence of dose interruptions due to AEs
Part 3: Dose dose modifications due to AEs
Incidence of dose modifications due to AEs
Part 3: Discontinuations due to AEs
Incidence of discontinuations due to AEs
Part 3: Time to event endpoints in each combination
Time to event endpoints in each combination
Part 3: Disease Control Rate (DCR)
DCR
Part 1/2/3: PK parameters of PF-07799933, Single dose, maximum observed concentration (Cmax)
PK parameters of PF-07799933, Single dose, Cmax
Part 1/2/3: PK parameters of PF-07799933, Single dose, time to maximum plasma concentration (Tmax)
PK parameters of PF-07799933, Single dose, Tmax
Part 1/2/3: PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast)
PK parameters of PF-07799933, Single dose, AUClast
Part 1/2/3: PK parameters of PF-07799933, Single dose, area under plasma concentration-time curve over 24 hours (AUC24)
PK parameters of PF-07799933, Single dose, AUC24
Part 1/2/3: PK parameters of PF-07799933, Single dose, area under plasma concentration-time curve over 48 hours (AUC48)
PK parameters of PF-07799933, Single dose, AUC48
Part 1/2/3: PK parameters of PF-07799933, Single dose, terminal elimination half life (tΒ½)
PK parameters of PF-07799933, Single dose, tΒ½
Part 1/2/3: PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf)
PK parameters of PF-07799933, Single dose, AUCinf
Part 1/2/3: PK parameters of PF-07799933, Single dose, apparent oral clearance (CL/F)
PK parameters of PF-07799933, Single dose, CL/F
Part 1/2/3: PK parameters of PF-07799933, Single dose, apparent volume of distribution (Vz/F)
PK parameters of PF-07799933, Single dose, Vz/F
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, maximum observed concentration (Cmax)
PK parameters of PF-07799933, Multiple dose, Cmax
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, trough plasma or serum concentration (Ctrough)
PK parameters of PF-07799933, Multiple dose, Ctrough
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, time to maximum plasma concentration (Tmax)
PK parameters of PF-07799933, Multiple dose, Tmax
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCΟ„)
PK parameters of PF-07799933, Multiple dose, AUCΟ„
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, CL/F
PK parameters of PF-07799933, Multiple dose, CL/F
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, average plasma concentration (Cav)
PK parameters of PF-07799933, Multiple dose, Cav
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, peak-to-trough ratio (PTR)
PK parameters of PF-07799933, Multiple dose, PTR
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, accumulation ratio (Rac)
PK parameters of PF-07799933, Multiple dose, Rac (AUCΟ„ /AUCsd,Ο„)
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, t1/2
PK parameters of PF-07799933, Multiple dose, t1/2
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, Vz/F
PK parameters of PF-07799933, Multiple dose, Vz/F
Part 3: PK parameters of cytochrome P450 (CYP)3A4 probe substrate midazolam, Cmax
PK parameters of CYP3A4 probe substrate midazolam, Cmax
Part 3: PK parameters of CYP3A4 probe substrate midazolam, Tmax
PK parameters of CYP3A4 probe substrate midazolam, Tmax
Part 3: PK parameters of CYP3A4 probe substrate midazolam, AUClast
PK parameters of CYP3A4 probe substrate midazolam, AUClast
Part 3: PK parameters of CYP3A4 probe substrate midazolam, tΒ½
PK parameters of CYP3A4 probe substrate midazolam, tΒ½
Part 3: PK parameters of CYP3A4 probe substrate midazolam, AUCinf
PK parameters of CYP3A4 probe substrate midazolam, AUCinf
Part 3: PK parameters of CYP3A4 probe substrate midazolam, CL/F
PK parameters of CYP3A4 probe substrate midazolam, CL/F
Part 3: PK parameters of CYP3A4 probe substrate midazolam, Vz/F
PK parameters of CYP3A4 probe substrate midazolam, Vz/F
Part 3: TTR
Time to response (TTR)
Part 3: DOR
Duration of response (DOR)
Part 3: PFS
Progression-free survival (PFS)
Part 3: OS
Overall survival (OS)
Number of participants with clinically significant physical exam abnormalities (Part 3)
Physical exam abnormalities as as graded by NCI CTCAE version 5.0

Full Information

First Posted
April 26, 2022
Last Updated
October 4, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05355701
Brief Title
A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors.
Official Title
A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
October 5, 2025 (Anticipated)
Study Completion Date
April 8, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines (called binimetinib and cetuximab) in people with solid tumors. This study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called "BRAF" and available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 1 or 2 times a day. Depending on the part of the study, participants may also receive another study medicine: People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day. People with colorectal cancer may also receive cetuximab. Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV). Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Colorectal Cancer, Non-Small-Cell Lung Cancer, Thyroid Cancer, Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monotherapy dose escalation (Part 1)
Arm Type
Experimental
Arm Description
Participants will receive PF-07799933
Arm Title
Combination dose escalation (Part 2)
Arm Type
Experimental
Arm Description
Participants will receive PF-07799933 in combination with binimetinib or cetuximab
Arm Title
Dose expansion (Part 3) - Tumor and mutation specific Cohort 1
Arm Type
Experimental
Arm Description
Participants will receive PF-07799933
Arm Title
Dose expansion (Part 3) - Tumor and mutation specific Cohort 2
Arm Type
Experimental
Arm Description
Participants will receive PF-07799933 in combination with binimetinib
Arm Title
Dose expansion (Part 3) - Tumor and mutation specific Cohort 3
Arm Type
Experimental
Arm Description
Participants will receive PF-07799933
Arm Title
Dose expansion (Part 3) - Tumor and mutation specific Cohort 4
Arm Type
Experimental
Arm Description
Participants will receive PF-07799933 in combination with cetuximab
Arm Title
Dose expansion (Part 3) - Tumor and mutation specific Cohort 5
Arm Type
Experimental
Arm Description
Participants will receive PF-07799933 in combination with cetuximab
Arm Title
Dose expansion (Part 3) - Basket Cohort 6
Arm Type
Experimental
Arm Description
Participants will receive PF-07799933 in combination with binimetinib or cetuximab
Intervention Type
Drug
Intervention Name(s)
PF-07799933
Other Intervention Name(s)
ARRY-440
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
binimetinib
Other Intervention Name(s)
Mektovi, PF-06811462, MEK162
Intervention Description
Tablet
Intervention Type
Biological
Intervention Name(s)
cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
Injection for intravenous use
Primary Outcome Measure Information:
Title
Number of participants with dose limiting toxicities (DLTs) (Part 1 and Part 2)
Description
DLTs will be evaluated during the first cycle (21 days) as both a single agent or in combination with binimetinib or cetuximab
Time Frame
Cycle 1 (21 days)
Title
Number of participants with treatment-emergent adverse events (AEs) (Part 1 and Part 2)
Description
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Time Frame
Baseline to 28 days after last dose of study medication
Title
Number of participants with clinically significant change from baseline in laboratory abnormalities (Part 1 and Part 2)
Description
Laboratory abnormalities as characterized by type, frequency, severity, and timing
Time Frame
Baseline to 28 days after last dose of study treatment
Title
Number of participants with clinically significant change from baseline in vital sign abnormalities (Part 1 and Part 2)
Description
Vital sign abnormalities as characterized by type, frequency, severity, and timing
Time Frame
Baseline to 28 days after last dose of study treatment
Title
Dose interruptions due to AEs (Part 1 and Part 2)
Description
Incidence of dose interruptions due to AEs
Time Frame
Baseline to 2 years
Title
Dose dose modifications due to AEs (Part 1 and Part 2)
Description
Incidence of dose modifications due to AEs
Time Frame
Baseline to 2 years
Title
Discontinuations due to AEs (Part 1 and Part 2)
Description
Incidence of discontinuations due to AEs
Time Frame
Baseline to 2 years
Title
MTD (Part 1 and Part 2)
Description
Maximum tolerated dose (MTD)
Time Frame
Cycle 1 (21 days)
Title
RDE (Part 1 and Part 2)
Description
Recommended dose for expansion (RDE)
Time Frame
Cycle 1 (21 days)
Title
Overall response rate (ORR) (Part 3)
Description
Response will be evaluated via radiographical tumor assessments by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time Frame
Baseline to 2 years
Title
Number of participants with clinically significant physical exam abnormalities (Part 1 and Part 2)
Description
Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time Frame
Baseline to 28 days after last dose of study treatment
Secondary Outcome Measure Information:
Title
Part 1 and Part 2: ORR
Description
ORR as assessed using the RECIST version 1.1.
Time Frame
Baseline to 2 years
Title
Part 1/2/3: Intracranial response
Description
Intracranial response by RECIST version 1.1 (for brain metastases) & Response Assessment in Neuro-Oncology (RANO) - for primary brain tumors).
Time Frame
Baseline to 2 years
Title
Part 1 and Part 2: Duration of response
Description
Duration of response
Time Frame
Baseline to 2 years
Title
Part 3: Number of participants with treatment-emergent adverse events (AEs)
Description
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Time Frame
Baseline to 2 years
Title
Part 3: Number of participants with clinically significant change from baseline in laboratory abnormalities
Description
Laboratory abnormalities as characterized by type, frequency, severity, and timing
Time Frame
Baseline to 2 years
Title
Part 3: Number of participants with clinically significant change from baseline in vital sign abnormalities
Description
Vital sign abnormalities as characterized by type, frequency, severity, and timing
Time Frame
Baseline to 2 years
Title
Part 3: Dose interruptions due to AEs
Description
Incidence of dose interruptions due to AEs
Time Frame
Baseline to 2 years
Title
Part 3: Dose dose modifications due to AEs
Description
Incidence of dose modifications due to AEs
Time Frame
Baseline to 2 years
Title
Part 3: Discontinuations due to AEs
Description
Incidence of discontinuations due to AEs
Time Frame
Baseline to 2 years
Title
Part 3: Time to event endpoints in each combination
Description
Time to event endpoints in each combination
Time Frame
Baseline to 2 years
Title
Part 3: Disease Control Rate (DCR)
Description
DCR
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Single dose, maximum observed concentration (Cmax)
Description
PK parameters of PF-07799933, Single dose, Cmax
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Single dose, time to maximum plasma concentration (Tmax)
Description
PK parameters of PF-07799933, Single dose, Tmax
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast)
Description
PK parameters of PF-07799933, Single dose, AUClast
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Single dose, area under plasma concentration-time curve over 24 hours (AUC24)
Description
PK parameters of PF-07799933, Single dose, AUC24
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Single dose, area under plasma concentration-time curve over 48 hours (AUC48)
Description
PK parameters of PF-07799933, Single dose, AUC48
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Single dose, terminal elimination half life (tΒ½)
Description
PK parameters of PF-07799933, Single dose, tΒ½
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf)
Description
PK parameters of PF-07799933, Single dose, AUCinf
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Single dose, apparent oral clearance (CL/F)
Description
PK parameters of PF-07799933, Single dose, CL/F
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Single dose, apparent volume of distribution (Vz/F)
Description
PK parameters of PF-07799933, Single dose, Vz/F
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, maximum observed concentration (Cmax)
Description
PK parameters of PF-07799933, Multiple dose, Cmax
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, trough plasma or serum concentration (Ctrough)
Description
PK parameters of PF-07799933, Multiple dose, Ctrough
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, time to maximum plasma concentration (Tmax)
Description
PK parameters of PF-07799933, Multiple dose, Tmax
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCΟ„)
Description
PK parameters of PF-07799933, Multiple dose, AUCΟ„
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, CL/F
Description
PK parameters of PF-07799933, Multiple dose, CL/F
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, average plasma concentration (Cav)
Description
PK parameters of PF-07799933, Multiple dose, Cav
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, peak-to-trough ratio (PTR)
Description
PK parameters of PF-07799933, Multiple dose, PTR
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, accumulation ratio (Rac)
Description
PK parameters of PF-07799933, Multiple dose, Rac (AUCΟ„ /AUCsd,Ο„)
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, t1/2
Description
PK parameters of PF-07799933, Multiple dose, t1/2
Time Frame
Baseline to 2 years
Title
Part 1/2/3: PK parameters of PF-07799933, Multiple dose, Vz/F
Description
PK parameters of PF-07799933, Multiple dose, Vz/F
Time Frame
Baseline to 2 years
Title
Part 3: PK parameters of cytochrome P450 (CYP)3A4 probe substrate midazolam, Cmax
Description
PK parameters of CYP3A4 probe substrate midazolam, Cmax
Time Frame
Baseline to 2 years
Title
Part 3: PK parameters of CYP3A4 probe substrate midazolam, Tmax
Description
PK parameters of CYP3A4 probe substrate midazolam, Tmax
Time Frame
Baseline to 2 years
Title
Part 3: PK parameters of CYP3A4 probe substrate midazolam, AUClast
Description
PK parameters of CYP3A4 probe substrate midazolam, AUClast
Time Frame
Baseline to 2 years
Title
Part 3: PK parameters of CYP3A4 probe substrate midazolam, tΒ½
Description
PK parameters of CYP3A4 probe substrate midazolam, tΒ½
Time Frame
Baseline to 2 years
Title
Part 3: PK parameters of CYP3A4 probe substrate midazolam, AUCinf
Description
PK parameters of CYP3A4 probe substrate midazolam, AUCinf
Time Frame
Baseline to 2 years
Title
Part 3: PK parameters of CYP3A4 probe substrate midazolam, CL/F
Description
PK parameters of CYP3A4 probe substrate midazolam, CL/F
Time Frame
Baseline to 2 years
Title
Part 3: PK parameters of CYP3A4 probe substrate midazolam, Vz/F
Description
PK parameters of CYP3A4 probe substrate midazolam, Vz/F
Time Frame
Baseline to 2 years
Title
Part 3: TTR
Description
Time to response (TTR)
Time Frame
Baseline to 2 years
Title
Part 3: DOR
Description
Duration of response (DOR)
Time Frame
Baseline to 2 years
Title
Part 3: PFS
Description
Progression-free survival (PFS)
Time Frame
Baseline to 2 years
Title
Part 3: OS
Description
Overall survival (OS)
Time Frame
Baseline to 2 years
Title
Number of participants with clinically significant physical exam abnormalities (Part 3)
Description
Physical exam abnormalities as as graded by NCI CTCAE version 5.0
Time Frame
Baseline to 28 days after last dose of study medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
This study is seeking participants who meet the following eligibility criteria: Inclusion Criteria: Diagnosis of advanced/metastatic solid tumor including primary brain tumor. Qualifying BRAF alteration (V600 or non-V600 Class II/Class III BRAF alteration), in tumor tissue and/or blood (ie circulating tumor deoxyribonucleic acid [DNA], or ctDNA). Disease progressed during/following last prior treatment and no satisfactory alternative treatment options (Part 1 and Part 2). Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies Exclusion Criteria: Brain metastasis larger than 4 cm Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment. For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Individual Site Status
Recruiting
Facility Name
Highlands Oncology Group
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Recruiting
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical And Translational Research Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
UCHealth Sue Anschutz-Rodgers Eye Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami Hospital and Clinics, Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
DFCI Chestnut Hill
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Individual Site Status
Recruiting
Facility Name
Brigitte Harris Cancer Pavilion
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Medical Center - Columbus
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Individual Site Status
Recruiting
Facility Name
MSK David H. Koch Center for Cancer Care
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center 53rd street
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Cancer Institute Franz Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute - Pharmacy
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
TriStar Bone Marrow Transplant
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
TriStar Centennial Medical Center - Cell Processing Lab
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
TriStar Centennial Medical center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
South Texas Accelerated Research Therapeutics (START)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
McGill University Health Centre
City
MontrΓ©al
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center
City
Petah Tikva
State/Province
Hamerkaz
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Sourasky Medical Center
City
Tel Aviv
State/Province
Tell AbΔ«b
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Hadassah Medical Center
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4761001
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors.

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