Neoplasms

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nerve Sheath Neoplasms

Neurofibrosarcoma

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Fibrosarcoma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Neurofibromatosis

Neurofibromatosis Type 1

Malignant Peripheral Nerve Sheath Tumor

Soft Tissue Sarcoma

All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

During the dose escalation phase, patients enrolled in the group will first receive a single fasting administration（AL2846 capsules 120-150mg，oral）. The observation period is 3 days. If dose-limited toxity (DLT) does not occur, they will continue to receive multiple consecutive fasting administrations (120mg-150mg，once a day，oral ),every 28 days as a treatment cycle.

During the dose expansion phase, patients will receive multiple consecutive fasting administrations (AL2846 capsules，120mg-150mg, oral ), every 28 days as a treatment cycle.

AL2846 is a multi-target receptor tyrosine kinase inhibitor.

AL2846 capsules

AL2846 is a multi-target receptor tyrosine kinase inhibitor. The purpose of this study is to evaluate the safety and efficacy of AL2846 capsules in Chinese patients with type I neurofibromatosis (NF1) (neurofibromas and malignant peripheral nerve sheath tumors).

A Clinical Trial to Evaluate the Safety and Efficacy of AL2846 Capsules in Chinese Patients With Type I Neurofibromatosis

Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of AL2846 Capsules in Chinese Patients With Type I Neurofibromatosis (Neurofibromatosis and Malignant Peripheral Nerve Sheath Tumors)

The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)

Percentage of participants achieving complete response (CR) and partial response (PR).

recommended dose of Phase II clinical trial

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

The time when the participants first achieved complete or partial remission to disease progression.

Rate of patients with PFS reaching one year among all patients

From date of first administration of test drug until the date of death from any cause

Self-report of pain in target tumor and other parts of body

Questionnaires about the quality of life (including mental state, appetite state, sleep, etc.)

Self-report on the severity of tumor pain, overall pain status, and tumor-related problems other than pain (vision, hearing, mobility, hearing, appearance, etc.)

Spots Global Cancer Trial Database for A Clinical Trial to Evaluate the Safety and Efficacy of AL2846 Capsules in Chinese Patients With Type I Neurofibromatosis

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial