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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: NCT01784562 No longer available - Clinical trials for Hypertension, Pulmonary

Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

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

The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.

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: NCT01473043 No longer available - Clinical trials for Renal Cell Carcinoma

Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment

Start date: March 2012
Phase: N/A
Study type: Expanded Access

This is a single arm study with axitinib in patients with advanced kidney cancer (clear cell variant), who have failed first line therapy. The study will recruit a maximum of 30 patients from 2 countries including Australia and Canada. Patients will be followed up for efficacy, safety and health related outcomes.

NCT ID: NCT00801515 No longer available - HIV Clinical Trials

A Compassionate Access Protocol For Those Patients Who Have Completed A4001029

Start date: August 2009
Phase: Phase 3
Study type: Expanded Access

This is a compassionate study to provide continued access to maraviroc for only those subjects completing study A4001029 who are showing clinical benefit. Assessments of safety and tolerability of maraviroc when added to OBT will be continued.

NCT ID: NCT00799539 No longer available - Multiple Myeloma Clinical Trials

A Study to Further Assess Safety and Effectiveness Data of the Bortezomib(Velcade)/Melphalan/Prednisone (BMP) Regimen in Previously Untreated and Transplant Ineligible Multiple Myeloma Patients

Start date: n/a
Phase: Phase 3
Study type: Expanded Access

The primary reason for this study is to further assess safety and efficacy data of the bortezomib/melphalan/prednisone (BMP) regimen in previously untreated and transplant ineligible multiple myeloma patients

NCT ID: NCT00759018 No longer available - Clinical trials for Graft vs Host Disease

Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD

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

This protocol allows for the treatment of pediatric patients, male and female, between the ages of 2 months and 17 years. Patients must have failed steroid treatment for Grade B-D acute GVHD.

NCT ID: NCT00655252 No longer available - Clinical trials for Metastatic Renal Cell Cancer

Expanded Access Study of RAD001 in Metastatic Renal Cell Cancer Patients Who Are Intolerant of or Who Have Failed Despite Prior Vascular Endothelial Growth Factor Therapy

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

This expanded access study is designed to provide RAD001 to patients with MRCC who are without satisfactory treatment alternatives, until RAD001 becomes commercially available.

NCT ID: NCT00413270 No longer available - Clinical trials for Chronic Myelogenous Leukemia

Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant

Start date: December 2006
Phase: Phase 3
Study type: Expanded Access

This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with nilotinib. Patients will be provided access to nilotinib until the drug is available on the market.

NCT ID: NCT00302016 No longer available - Clinical trials for Chronic Myeloid Leukemia

Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia

Start date: January 2006
Phase: Phase 3
Study type: Expanded Access

This study will further evaluate if AMN107 is safe in adults with chronic myeloid leukemia who are resistant or intolerant to imatinib and to provide patients access to this new drug until the drug becomes commercially available.