Neoplasms

All Conditions

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Hemangioma

Hemangioma, Capillary

Port-Wine Stain

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Congenital Abnormalities

Skin Abnormalities

Skin Diseases

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Propranolol

Adrenergic beta-Antagonists

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

propranolol gel

Placebo

There is an unsatisfied medical need for a first-line treatment of localized uncomplicated proliferating Infantile Hemangioma with a good benefit/risk profile.

Pierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A) which is a topical gel adapted to paediatric use.

The objective of this study is to evaluate topical propranolol efficacy and safety in the management of localized hemangioma.

Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo

A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo.

Complete/nearly complete resolution of the Infantile Hemangioma at week 12 compared to baseline

categorical endpoints for Infantile Hemangioma evolution (4-points scale)

Persistence of complete/nearly complete resolution of the Infantile Hemangioma at week 24 compared to week 12.

Pierre Fabre Dermatology

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Rare Diseases

Carcinoma

Melanoma

Carcinoma, Non-Small-Cell Lung

Glioma

Thyroid Neoplasms

Thyroid Diseases

Brain Neoplasms

Lung Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroendocrine Tumor

Neuroepithelioma

Participants will receive PF-07799544 and PF-07799933

PF-07799544

PF-07799933

encorafenib

Pfizer CT.gov Call Center

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.

A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors

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

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.

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)

Response will be evaluated via radiographical tumor assessments by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy

Laboratory abnormalities as characterized by type, frequency, severity, and timing.

Vital sign abnormalities as characterized by type, frequency, severity, and timing.

Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

PK parameters of PF-07799544, Single dose, Cmax

PK parameters of PF-07799544, Single dose, Tmax

PK parameters of PF-07799544, Single dose, AUClast

PK parameters of PF-07799544, Single dose, AUCinf

PK parameters of PF-07799544, Single dose, t½

PK parameters of PF-07799544, Single dose, CL/F

PK parameters of PF-07799544, Single dose, Vz/F

PK parameters of PF-07799544, Multiple dose, Cmax

PK parameters of PF-07799544, Multiple dose, Tmax

PK parameters of PF-07799544, Multiple dose, AUCτ

PK parameters of PF-07799544, Multiple dose, t½

PK parameters of PF-07799544, Multiple dose, CL/F

PK parameters of PF-07799544, Multiple dose, Vz/F

PK parameters of PF-07799933, Single dose, Cmax

PK parameters of PF-07799933, Single dose, Tmax

PK parameters of PF-07799933, Single dose, AUClast

PK parameters of PF-07799933, Single dose, AUCinf

PK parameters of PF-07799933, Single dose, t½

PK parameters of PF-07799933, Single dose, CL/F

PK parameters of PF-07799933, Single dose, Vz/F

PK parameters of PF-07799933, Multiple dose, Cmax

PK parameters of PF-07799933, Multiple dose, Tmax

PK parameters of PF-07799933, Multiple dose, AUCτ

PK parameters of PF-07799933, Multiple dose, t½

PK parameters of PF-07799933, Multiple dose, CL/F

PK parameters of PF-07799933, Multiple dose, Vz/F

ORR as assessed using the RECIST version 1.1.

Intracranial response by RECIST version 1.1 (for brain metastases)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo	NCT01512173	Infantile Heman...	propranolol gel Placebo	35 Days - 150 Days	Pierre Fabre Dermatology
Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo	NCT01512173	Infantile Heman...	propranolol gel Placebo	35 Days - 150 Days	Pierre Fabre Dermatology
A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors	NCT05538130	Melanoma Glioma Thyroid Cancer Non-Small Cell ... Malignant Neopl... Brain Neoplasms Colorectal Canc...	PF-07799544 PF-07799933 encorafenib	16 Years -	Pfizer
A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors	NCT05538130	Melanoma Glioma Thyroid Cancer Non-Small Cell ... Malignant Neopl... Brain Neoplasms Colorectal Canc...	PF-07799544 PF-07799933 encorafenib	16 Years -	Pfizer

Spots Global Cancer Trial Database for neoplasm by histologic type