Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Keratosis, Actinic

Keratosis

Carcinoma, Basal Cell

Bowen's Disease

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Precancerous Conditions

Neoplasms, Basal Cell

Carcinoma, Squamous Cell

Neoplasms, Squamous Cell

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Methyl 5-aminolevulinate

Photosensitizing Agents

Metvix (methyl aminolevulinate) (MAL), Photodynamic Therapy (PDT), cream, 160 mg/g. MAL cream will be applied for 3 hours then will be removed. The target area will then be exposed to red light (using a large-field LED light source: Aktilite 128) for 7 to 10 minutes at a dosage of 37 J/cm².

Metvix (methyl aminolevulinate)

The aim of this study is to provide this investigational drug to patients who cannot be optimally treated with conventional therapies and to collect efficacy and safety data on the use of Metvix PDT in subjects with field actinic keratoses, large/multiple superficial basal cell carcinomas (BCCs) or Bowen's disease.

Compassionate Use of Metvix® (Methyl Aminolevulinate) Photodynamic Therapy (PDT) in Subjects With Field Actinic Keratoses, Large/Multiple Superficial Basal Cell Carcinomas (BCCs), or Bowen's Disease

Compassionate Use of Metvix® (Methyl Aminolevulinate) PDT in Subjects With Field Actinic Keratoses, Large/Multiple Superficial BCCs, or Bowen's Disease

Galderma R&D

Director, Regulatory, Medical & Technical Affairs

Nervous System Diseases

Gland and Hormone Related Diseases

Eye Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Pituitary Diseases

Melanoma

Neuroendocrine Tumors

Glioma

Retinoblastoma

Sarcoma

Mesothelioma

Mesothelioma, Malignant

Osteosarcoma

Medulloblastoma

Neuroblastoma

Carcinoid Tumor

Rhabdomyosarcoma

Ocular Melanoma

Neuroendocrine Tumor

Soft Tissue Sarcoma

Malignant Mesothelioma

Pancreatic Neuroendocrine Tumor

Vasoconstrictor Agents

Respiratory System Agents

Hematinics

Epinephrine

Liver Extracts

Racepinephrine

Epinephryl borate

ENV-101 (taladegib) tablets, 200 mg once-daily in 28-day cycles

ENV-101 (taladegib) tablets, 300 mg once-daily in 28-day cycles

ENV-101 (taladegib)

Paul Frohna, M.D., Ph.D.

This study employs a 2-stage design that aims to evaluate the efficacy and safety of ENV- 101, a potent Hedgehog (Hh) pathway inhibitor, in patients with refractory advanced solid tumors characterized by loss of function (LOF) mutations in the Patched-1 (PTCH1) gene. Stage 1 of this study will enroll approximately 44 patients randomized between two dose levels. As appropriate, Stage 2 of the study will expand enrollment based on the results of Stage 1.

A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations

A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations

ORR is comprised of Complete Response (CR) and Partial Response (PR), measured by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1), as determined by an independent review (confirmed CR or PR will be defined as a repeat assessment performed no less than 28 days after the criteria for response is first met).

Unacceptable toxicities = non-hematologic AEs \>= Grade 3 in severity, not including alopecia and fatigue.

Best overall response of confirmed CR or PR as determined by the treating Investigator using RECIST 1.1.

CBR = the proportion of patients who achieved CR, PR or stable disease as determined by the treating Investigator using RECIST 1.1.

OS = Number of months from initiation of study medication to the date of death due to any cause or last follow up.

DOR = the number of months from the start of CR or PR, whichever response is recorded first and subsequently confirmed, to the first date that recurrent or progressive disease is documented or death.

PFS = number of months from initiation of study medication to the earlier of disease progression or death due to any cause or last follow up.

Percentage change in inhibition of Gli1, a marker for inhibition of the Hedgehog pathway, in skin biopsies.

Measurement of trough concentration of study medication in blood at Baseline and the end of each 28-day treatment cycle

Endeavor Biomedicines, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Compassionate Use of Metvix® (Methyl Aminolevulinate) Photodynamic Therapy (PDT) in Subjects With Field Actinic Keratoses, Large/Multiple Superficial Basal Cell Carcinomas (BCCs), or Bowen's Disease	NCT00535080	Field Actinic K... Basal Cell Carc... Bowen's Disease	Metvix (methyl ...	18 Years -	Galderma R&D
Compassionate Use of Metvix® (Methyl Aminolevulinate) Photodynamic Therapy (PDT) in Subjects With Field Actinic Keratoses, Large/Multiple Superficial Basal Cell Carcinomas (BCCs), or Bowen's Disease	NCT00535080	Field Actinic K... Basal Cell Carc... Bowen's Disease	Metvix (methyl ...	18 Years -	Galderma R&D
A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations	NCT05199584	Solid Tumors Wi...	ENV-101 (talade...	18 Years -	Endeavor Biomedicines, Inc.

Spots Global Cancer Trial Database for basal

Every month we try and update this database with for basal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for basal

Every month we try and update this database with for basal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for basal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.