Clinical trials: Peripheral Nerve Sheath Tumors
Neurofibromatosis 1, Plexiform Neurofibroma (PN)
Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas
A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic, inoperable plexiform neurofibromas.
- Trial name
- KOMET (NCT04924608)
- Testing
- Selumetinib
- Where
- 34 sites in United States, Australia and 11 more
- Volunteers
- 145 people
- Sponsor
- AstraZeneca
Vestibular Schwannoma
Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy
This multi-center, observational, post-intervention LTFU study will monitor for safety and efficacy of AAVAnc80- antiVEGF in individuals with vestibular schwannoma who have previously received an intracochlear administration of…
- Trial name
- NCT07503613
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Akouos, Inc.
Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs), Healthy Participants
A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants
This study will evaluate bioavailability and food effect of selumetinib (AZD6244) in healthy male participants. A total of 24 healthy male participants will be included to ensure at least 20 evaluable participants.
- Trial name
- NCT03649165
- Testing
- Treatment A, Treatment B, Treatment C
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Neuroma
ALGRX 4975 in the Treatment of Patients With Morton's Neuroma
Subjects will have painful primary or post-operative intermetatarsal neuroma. Study drug or placebo will be injected into the space containing the neuroma.
- Trial name
- NCT00130962
- Testing
- ALGRX 4975
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- AlgoRx Pharmaceuticals
Neurofibromatosis 1, Neurofibroma, Plexiform
Real-World Treatment Study of Koselugo (Selumetinib)
As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients treated with Koselugo (Selumetinib), an oral selective inhibitor of MAPK kinase (MEK) 1 and…
- Trial name
- NCT06360406
- Where
- 12 sites in South Korea
- Volunteers
- 200 people
- Sponsor
- AstraZeneca
Neurofibromatosis 1, Plexiform Neurofibroma
Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1
FCN-159 is a highly active MEK1/2 inhibitor that was designed, synthesized and screened on the basis of the structure of trametinib.
- Conditions
- Neurofibromatosis 1, Plexiform Neurofibroma, NF1
- Trial name
- NCT04954001
- Testing
- FCN-159
- Where
- 14 sites in United States, China and 1 more
- Volunteers
- 160 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Malignant Neoplasms
A Study of DEG6498 in Participants With Solid Tumors
The goal of this first in human, Phase 1, multi-center, open-label, and 2-part study is to learn whether DEG6498 is safe and tolerable in participants with advanced solid tumors.
- Trial name
- NCT07244835
- Testing
- DEG6498
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Degron Therapeutics Co.
Leiomyosarcoma, Liposarcoma
MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma
This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma.
- Conditions
- Leiomyosarcoma, Liposarcoma, Synovial Sarcoma, Angiosarcoma
- Trial name
- NCT06277154
- Testing
- MASCT-I, Doxorubicin, Ifosfamide
- Where
- China
- Volunteers
- 148 people
- Sponsor
- HRYZ Biotech Co.
Cancer
Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations
This was a 4-part (Part A, Part B, Part C and Part D), Phase I/IIa, multi-center, open label, study in pediatric subjects with refractory or recurrent tumors.
- Trial name
- NCT02124772
- Testing
- Trametinib, Dabrafenib
- Where
- 16 sites in United States, Australia and 3 more
- Volunteers
- 139 people
- Sponsor
- Novartis Pharmaceuticals
Malignant Peripheral Nerve Sheath Tumors
Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors
This study assesses the safety and efficacy of imatinib mesylate treatment of patients with malignant peripheral nerve sheath tumors
- Trial name
- NCT00427583
- Testing
- imatinib mesylate
- Where
- 2 sites in Germany
- Volunteers
- 11 people
- Sponsor
- Novartis Pharmaceuticals
Neurofibromatosis Type 1
Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN
This study is designed to define a dosing regimen and assess the pharmacokinetics(PK) and safety of the granule formulation; the study will also include descriptive analyses of exploratory efficacy endpoints.
- Trial name
- SPRINKLE (NCT05309668)
- Testing
- Selumetinib granule formulation, Selumetinib capsule formulation
- Where
- 16 sites in United States, Germany and 5 more
- Volunteers
- 36 people
- Sponsor
- AstraZeneca
Life Threatening Diseases
Phase II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases
Exploratory study to examine the effect(s) of Imatinib mesylate treatment on life threatening rare diseases with known associations to one or more Imatinib mesylate -sensitive tyrosine kinases, and to identify the contribution of…
- Trial name
- NCT00154388
- Testing
- Imatinib mesylate
- Volunteers
- 185 people
- Sponsor
- Novartis Pharmaceuticals
Locally Advanced Solid Tumor
Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion…
- Trial name
- NCT05732831
- Testing
- TNG462, Pembrolizumab
- Where
- 26 sites in United States, France and 1 more
- Volunteers
- 225 people
- Sponsor
- Tango Therapeutics, Inc.
Symptomatic Neuroma, Amputation
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention…
- Conditions
- Symptomatic Neuroma, Amputation, Chronic Nerve Pain
- Trial name
- REPOSE-XL℠ (NCT04865679)
- Testing
- Axoguard Nerve Cap®
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Axogen Corporation
NF type1 With Inoperable Plexiform Neurofibromas
An Intermediate Access Protocol for Selumetinib for Treatment of Neurofibromatosis Type 1
This will be an open-label, single-arm, multicenter intermediate access protocol which provides treatment access to selumetinib for eligible patients with neurofibromatosis type 1 (NF1) who have inoperable…
- Trial name
- NCT03259633
- Testing
- Selumetinib
- Where
- United States
- Sponsor
- AstraZeneca
Neurofibromatosis Type 1-Associated Plexiform Neurofibromas, Histiocytic Neoplasm
Individual Patient Compassionate Use of Mirdametinib
This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee, and applicable competent authority approval.
- Conditions
- Neurofibromatosis Type 1-Associated Plexiform Neurofibromas, Histiocytic Neoplasm, Other MAP-K Pathway Driven Diseases
- Trial name
- NCT05028166
- Testing
- Mirdametinib (MEK Inhibitor)
- Where
- 2 sites in United States, Germany
- Sponsor
- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Chronic Neuropathic Pain
Surgical Treatment of Chronic Neuropathic Pain
Observational registry study assessing the subject's pain history and the impact of surgery for the treatment of chronic neuropathic pain by comparing post-operative outcomes (pain level, pain medication usage, quality of life…
- Trial name
- Rethink Pain (NCT04287075)
- Testing
- Surgical Management of Neuroma
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Axogen Corporation
Locally Advanced Solid Tumor
Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors
This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion…
- Trial name
- NCT05275478
- Testing
- TNG908
- Where
- 20 sites in United States, France
- Volunteers
- 110 people
- Sponsor
- Tango Therapeutics, Inc.
Type I Neurofibromatosis
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQ-B3234 in Patients With Type I Neurofibromatosis
This study is a Phase I clinical trial to evaluate the tolerability and pharmacokinetics of TQ-B3234 capsules in Chinese subjects associated with neurofibromatosis type I (neurofibroma and peripheral malignant neurilemmoma).
- Trial name
- NCT05107037
- Testing
- TQ-B3234 capsule
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Carpal Tunnel Syndrome
Safety and Efficacy of Lidoderm (Lidocaine Patch 5%) in Treating Moderate to Severe Pain Associated With Carpal Tunnel Syndrome
The purpose of this study is to evaluate the analgesic efficacy and safety of the lidocaine patch 5% compared to placebo in patients with moderate to severe pain associated with carpal tunnel syndrome.
- Trial name
- NCT00266214
- Testing
- lidocaine patch 5%
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company