Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05538130
Registration number
NCT05538130
Ethics application status
Date submitted
9/09/2022
Date registered
13/09/2022
Date last updated
4/09/2025
Titles & IDs
Public title
A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors
Query!
Scientific title
A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Query!
Secondary ID [1]
0
0
C4901001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Melanoma
0
0
Query!
Glioma
0
0
Query!
Thyroid Cancer
0
0
Query!
Non-Small Cell Lung Cancer
0
0
Query!
Malignant Neoplasms
0
0
Query!
Brain Neoplasms
0
0
Query!
Colorectal Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Malignant melanoma
Query!
Cancer
0
0
0
0
Query!
Brain
Query!
Cancer
0
0
0
0
Query!
Thyroid
Query!
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Cancer
0
0
0
0
Query!
Bowel - Back passage (rectum) or large bowel (colon)
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - PF-07799544
Treatment: Drugs - PF-07799933
Treatment: Drugs - encorafenib
Experimental: Monotherapy Dose Escalation (Phase 1a) - Participants will receive PF-07799544
Experimental: Phase 1b Substudy B Combination Dose Escalation - Participants will receive PF-07799544 and PF-07799933
Experimental: Phase 1b Substudy B Combination Dose Expansion - Participants will receive PF-07799544 and PF-07799933
Experimental: Phase 1b Substudy C Combination Dose Expansion - Participants will receive PF-07799544 and PF-07799933
Treatment: Drugs: PF-07799544
Tablet
Treatment: Drugs: PF-07799933
Tablet
Treatment: Drugs: encorafenib
Capsule
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of participants with dose limiting toxicities (DLTs) Phase 1a monotherapy and Phase 1b combination therapy dose escalation
Query!
Assessment method [1]
0
0
DLTs will be evaluated during the first cycle (21 days) as a single agent (phase 1a monotherapy) or in combination with other agents (phase 1b dose escalation)
Query!
Timepoint [1]
0
0
Cycle 1 (21 days)
Query!
Primary outcome [2]
0
0
Overall response rate (ORR) (phase 1b expansion)
Query!
Assessment method [2]
0
0
Response will be evaluated via radiographical tumor assessments by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Query!
Timepoint [2]
0
0
Baseline to 2 years
Query!
Primary outcome [3]
0
0
Number of participants with treatment-emergent adverse events (AEs) (phase 1a and 1b dose escalation phases)
Query!
Assessment method [3]
0
0
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Query!
Timepoint [3]
0
0
Baseline to 28 days after last dose of study medication
Query!
Primary outcome [4]
0
0
Number of participants with clinically significant change from baseline in laboratory abnormalities (phase 1a and phase 1b dose escalation phase)
Query!
Assessment method [4]
0
0
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Query!
Timepoint [4]
0
0
Baseline to 28 days after last dose of study treatment
Query!
Primary outcome [5]
0
0
Number of participants with clinically significant change from baseline in vital sign abnormalities (phase 1a and phase 1b dose escalation phase)
Query!
Assessment method [5]
0
0
Vital sign abnormalities as characterized by type, frequency, severity, and timing.
Query!
Timepoint [5]
0
0
Baseline to 28 days after last dose of study treatment
Query!
Primary outcome [6]
0
0
Number of participants with clinically significant change from baseline in physical exam abnormalities (phase 1a and phase 1b dose escalation phase)
Query!
Assessment method [6]
0
0
Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Query!
Timepoint [6]
0
0
Baseline to 28 days after last dose of study treatment
Query!
Secondary outcome [1]
0
0
Number of participants with treatment-emergent adverse events (AEs)
Query!
Assessment method [1]
0
0
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Query!
Timepoint [1]
0
0
Baseline to 2 years
Query!
Secondary outcome [2]
0
0
Number of participants with clinically significant change from baseline in laboratory abnormalities
Query!
Assessment method [2]
0
0
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Query!
Timepoint [2]
0
0
Baseline to 2 years
Query!
Secondary outcome [3]
0
0
Number of participants with clinically significant change from baseline in vital sign abnormalities
Query!
Assessment method [3]
0
0
Vital sign abnormalities as characterized by type, frequency, severity, and timing.
Query!
Timepoint [3]
0
0
Baseline to 2 years
Query!
Secondary outcome [4]
0
0
PK parameters of PF-07799544, Single dose, maximum observed concentration (Cmax)
Query!
Assessment method [4]
0
0
PK parameters of PF-07799544, Single dose, Cmax
Query!
Timepoint [4]
0
0
Baseline to 2 years
Query!
Secondary outcome [5]
0
0
PK parameters of PF-07799544, Single dose, time to maximum plasma concentration (Tmax)
Query!
Assessment method [5]
0
0
PK parameters of PF-07799544, Single dose, Tmax
Query!
Timepoint [5]
0
0
Baseline to 2 years
Query!
Secondary outcome [6]
0
0
PK parameters of PF-07799544, Single dose, area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast)
Query!
Assessment method [6]
0
0
PK parameters of PF-07799544, Single dose, AUClast
Query!
Timepoint [6]
0
0
Baseline to 2 years
Query!
Secondary outcome [7]
0
0
PK parameters of PF-07799544, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf)
Query!
Assessment method [7]
0
0
PK parameters of PF-07799544, Single dose, AUCinf
Query!
Timepoint [7]
0
0
Baseline to 2 years
Query!
Secondary outcome [8]
0
0
PK parameters of PF-07799544, Single dose, terminal elimination half life (t½)
Query!
Assessment method [8]
0
0
PK parameters of PF-07799544, Single dose, t½
Query!
Timepoint [8]
0
0
Baseline to 2 years
Query!
Secondary outcome [9]
0
0
PK parameters of PF-07799544, Single dose, apparent oral clearance (CL/F)
Query!
Assessment method [9]
0
0
PK parameters of PF-07799544, Single dose, CL/F
Query!
Timepoint [9]
0
0
Baseline to 2 years
Query!
Secondary outcome [10]
0
0
PK parameters of PF-07799544, Single dose, apparent volume of distribution (Vz/F)
Query!
Assessment method [10]
0
0
PK parameters of PF-07799544, Single dose, Vz/F
Query!
Timepoint [10]
0
0
Baseline to 2 years
Query!
Secondary outcome [11]
0
0
PK parameters of PF-07799544, Multiple dose, maximum observed concentration (Cmax)
Query!
Assessment method [11]
0
0
PK parameters of PF-07799544, Multiple dose, Cmax
Query!
Timepoint [11]
0
0
Baseline to 2 years
Query!
Secondary outcome [12]
0
0
PK parameters of PF-07799544, Multiple dose, time to maximum plasma concentration (Tmax)
Query!
Assessment method [12]
0
0
PK parameters of PF-07799544, Multiple dose, Tmax
Query!
Timepoint [12]
0
0
Baseline to 2 years
Query!
Secondary outcome [13]
0
0
PK parameters of PF-07799544, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCt)
Query!
Assessment method [13]
0
0
PK parameters of PF-07799544, Multiple dose, AUCt
Query!
Timepoint [13]
0
0
Baseline to 2 years
Query!
Secondary outcome [14]
0
0
PK parameters of PF-07799544, Multiple dose, terminal elimination half life (t½)
Query!
Assessment method [14]
0
0
PK parameters of PF-07799544, Multiple dose, t½
Query!
Timepoint [14]
0
0
Baseline to 2 years
Query!
Secondary outcome [15]
0
0
PK parameters of PF-07799544, Multiple dose, apparent oral clearance (CL/F)
Query!
Assessment method [15]
0
0
PK parameters of PF-07799544, Multiple dose, CL/F
Query!
Timepoint [15]
0
0
Baseline to 2 years
Query!
Secondary outcome [16]
0
0
PK parameters of PF-07799544, Multiple dose, apparent volume of distribution (Vz/F)
Query!
Assessment method [16]
0
0
PK parameters of PF-07799544, Multiple dose, Vz/F
Query!
Timepoint [16]
0
0
Baseline to 2 years
Query!
Secondary outcome [17]
0
0
PK parameters of PF-07799933, Single dose, maximum observed concentration (Cmax)
Query!
Assessment method [17]
0
0
PK parameters of PF-07799933, Single dose, Cmax
Query!
Timepoint [17]
0
0
Baseline to 2 years
Query!
Secondary outcome [18]
0
0
PK parameters of PF-07799933, Single dose, time to maximum plasma concentration (Tmax)
Query!
Assessment method [18]
0
0
PK parameters of PF-07799933, Single dose, Tmax
Query!
Timepoint [18]
0
0
Baseline to 2 years
Query!
Secondary outcome [19]
0
0
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)
Query!
Assessment method [19]
0
0
PK parameters of PF-07799933, Single dose, AUClast
Query!
Timepoint [19]
0
0
Baseline to 2 years
Query!
Secondary outcome [20]
0
0
PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf)
Query!
Assessment method [20]
0
0
PK parameters of PF-07799933, Single dose, AUCinf
Query!
Timepoint [20]
0
0
Baseline to 2 years
Query!
Secondary outcome [21]
0
0
PK parameters of PF-07799933, Single dose, terminal elimination half life (t½)
Query!
Assessment method [21]
0
0
PK parameters of PF-07799933, Single dose, t½
Query!
Timepoint [21]
0
0
Baseline to 2 years
Query!
Secondary outcome [22]
0
0
PK parameters of PF-07799933, Single dose, apparent oral clearance (CL/F)
Query!
Assessment method [22]
0
0
PK parameters of PF-07799933, Single dose, CL/F
Query!
Timepoint [22]
0
0
Baseline to 2 years
Query!
Secondary outcome [23]
0
0
PK parameters of PF-07799933, Single dose, apparent volume of distribution (Vz/F)
Query!
Assessment method [23]
0
0
PK parameters of PF-07799933, Single dose, Vz/F
Query!
Timepoint [23]
0
0
Baseline to 2 years
Query!
Secondary outcome [24]
0
0
PK parameters of PF-07799933, Multiple dose, maximum observed concentration (Cmax)
Query!
Assessment method [24]
0
0
PK parameters of PF-07799933, Multiple dose, Cmax
Query!
Timepoint [24]
0
0
Baseline to 2 years
Query!
Secondary outcome [25]
0
0
PK parameters of PF-07799933, Multiple dose, time to maximum plasma concentration (Tmax)
Query!
Assessment method [25]
0
0
PK parameters of PF-07799933, Multiple dose, Tmax
Query!
Timepoint [25]
0
0
Baseline to 2 years
Query!
Secondary outcome [26]
0
0
PK parameters of PF-07799933, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCt)
Query!
Assessment method [26]
0
0
PK parameters of PF-07799933, Multiple dose, AUCt
Query!
Timepoint [26]
0
0
Baseline to 2 years
Query!
Secondary outcome [27]
0
0
PK parameters of PF-07799933, Multiple dose, terminal elimination half life (t½)
Query!
Assessment method [27]
0
0
PK parameters of PF-07799933, Multiple dose, t½
Query!
Timepoint [27]
0
0
Baseline to 2 years
Query!
Secondary outcome [28]
0
0
PK parameters of PF-07799933, Multiple dose, apparent oral clearance (CL/F)
Query!
Assessment method [28]
0
0
PK parameters of PF-07799933, Multiple dose, CL/F
Query!
Timepoint [28]
0
0
Baseline to 2 years
Query!
Secondary outcome [29]
0
0
PK parameters of PF-07799933, Multiple dose, apparent volume of distribution (Vz/F)
Query!
Assessment method [29]
0
0
PK parameters of PF-07799933, Multiple dose, Vz/F
Query!
Timepoint [29]
0
0
Baseline to 2 years
Query!
Secondary outcome [30]
0
0
ORR (phase 1a and phase 1b dose escalation)
Query!
Assessment method [30]
0
0
ORR as assessed using the RECIST version 1.1.
Query!
Timepoint [30]
0
0
Baseline to 2 years
Query!
Secondary outcome [31]
0
0
Duration of response overall and in CNS
Query!
Assessment method [31]
0
0
Query!
Timepoint [31]
0
0
Baseline to 2 years
Query!
Secondary outcome [32]
0
0
Intracranial response (phase 1b Part 2)
Query!
Assessment method [32]
0
0
Intracranial response by RECIST version 1.1 (for brain metastases)
Query!
Timepoint [32]
0
0
Baseline to 2 years
Query!
Secondary outcome [33]
0
0
PFS
Query!
Assessment method [33]
0
0
Query!
Timepoint [33]
0
0
Baseline to 2 years
Query!
Eligibility
Key inclusion criteria
* Diagnosis of advanced/metastatic solid tumor including primary brain tumor for monotherapy phase 1a dose escalation
* Disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation
* For Substudy B, histological or cytological diagnosis of advanced/metastatic melanoma
* For Substudy C, unresectable or adv/metastatic solid tumor progressed on, or with demonstrated intolerance to SOC, excluding melanoma,
* For Substudy B and C, measurable disease by RECIST version 1.1
* For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II/III alteration in tumor tissue and/or blood
* For Substudy C, evidence of a BRAF founder alteration (non-V600 Class II/III BRAF alteration)
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Brain metastasis larger than 4 cm
* History or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/11/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
29/04/2029
Query!
Actual
Query!
Sample size
Target
124
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment hospital [2]
0
0
Royal Melbourne Hospital - Parkville
Query!
Recruitment postcode(s) [1]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [2]
0
0
3052 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arkansas
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Massachusetts
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Michigan
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Minnesota
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New Jersey
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Ohio
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Oregon
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Tennessee
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Washington
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Alberta
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Ontario
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Quebec
Query!
Country [17]
0
0
Israel
Query!
State/province [17]
0
0
Central District
Query!
Country [18]
0
0
Israel
Query!
State/province [18]
0
0
Jerusalem
Query!
Country [19]
0
0
Israel
Query!
State/province [19]
0
0
Southern District
Query!
Country [20]
0
0
Israel
Query!
State/province [20]
0
0
TELL ABIB
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) administered as a single agent and in combination with other study medications in people with solid tumors. This study is seeking participants who have an advanced solid tumor for which the available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799544. PF-07799544 comes as a tablet to take by mouth daily (initially 2 times per day, but this could change to once daily or another frequency). Depending on the part of the study, participants may also receive another study medicine. * In the first part of the study, people with melanoma or other solid tumors may also receive encorafenib. Encorafenib comes as a capsule and is taken once per day. * In the second part of the study, people with melanoma or other cancers with abnormalities in a gene called "BRAF" will receive PF-07799544 with other study medicines (for example, PF-07799933). 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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05538130
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-800-718-1021
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
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.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05538130
Download to PDF