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NCT ID: NCT04667234 No longer available - Clinical trials for Non Small-cell Lung Cancer

Expanded Access of Sotorasib

Start date: n/a
Phase:
Study type: Expanded Access

The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting.

NCT ID: NCT02636686 No longer available - Clinical trials for Duchenne Muscular Dystrophy

Extension Study of Drisapersen in DMD Subjects

Start date: n/a
Phase: N/A
Study type: Expanded Access

This is a phase IIIb, multi-centre, open-label extension study in male subjects with DMD who previously have been treated with drisapersen, aiming at assessing the safety and efficacy of drisapersen.

NCT ID: NCT01871233 No longer available - Clinical trials for Partial Onset Seizures

An Extended Access Program for Perampanel

Start date: n/a
Phase:
Study type: Expanded Access

The Extended Access Program (EAP) is a managed access programme for Perampanel. The main objective of this EAP is to ensure that patients participating in studies E2007-A001-207, E2007-G000-307, or E2007-G000-235 continue to have access to perampanel until such time perampanel tablets become commercially available for the treatment of Partial Onset Seizures (POS) in the country in which they reside. This EAP will consist of 2 phases: - Screening: The patient will start the program once the Screening assessments are completed and the patient is qualified for participation. - Treatment: Additional assessments, physical examinations, and dosage changes will be clinically determined by the treating physician. Patients will enter this program on the same dose of perampanel that they were receiving at the end of their participation in previous study. Doses of perampanel and of concomitant anti-epileptic drugs (AEDs) can be adjusted (i.e., added,removed, or changed in dose) based on clinical judgment. Treatment will be prescribed as long as clinically appropriate according to the judgement of the treating physician and the approved Summary of Product Characteristics (SmPC). The program will complete in a staggered fashion, country by country, as and when perampanel becomes commercially available for the treatment of POS in each country.

NCT ID: NCT01538680 No longer available - Clinical trials for Colorectal Neoplasms

Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

CONSIGN
Start date: n/a
Phase:
Study type: Expanded Access

This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist, in the time between positive results and approval / availability on the market, and to collect safety data for regorafenib until market access. Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint of this study will be safety.

NCT ID: NCT00962260 No longer available - Gaucher Disease Clinical Trials

Expanded Access Trial of Plant Expressed Recombinant Glucocerebrosidase (prGCD) in Patients With Gaucher Disease

Start date: n/a
Phase:
Study type: Expanded Access

This is an open-label expanded access trial of prGCD in patients with Gaucher disease who require enzyme replacement therapy (ERT) and who have been treated with imiglucerase but for whom the dose has been reduced or discontinued due to shortage of the product.

NCT ID: NCT00210665 No longer available - Sarcoma Clinical Trials

A Study to Provide Access to Trabectedin in Participants With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care Treatment

Start date: n/a
Phase: N/A
Study type: Expanded Access

The purpose of this study is to facilitate access to trabectedin for eligible previously treated patients with soft tissue sarcoma (STS), who cannot be expected to benefit from currently available therapeutic options but who may benefit from treatment with trabectedin. The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment.

NCT ID: NCT00096811 No longer available - Hepatitis B Clinical Trials

Entecavir for Subjects With Chronic Hepatitis B Infection: An Early Access Program

Start date: September 2003
Phase: N/A
Study type: Expanded Access

The purpose of this clinical research study is to provide entecavir to subjects with chronic Hepatitis B infection who have failed or who have demonstrated intolerance of marketed therapies or for those in whom use of these agents is contraindicated and that have no other available treatment options.