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NCT ID: NCT00063791 No longer available - Multiple Myeloma Clinical Trials

A Study to Assess Two Different Strategies of Combining Dexamethasone and VELCADE

Start date: n/a
Phase: Phase 2
Study type: Expanded Access

The purpose of this study is to give patients who have had 4 or more prior lines of therapy for multiple myeloma access to VELCADE. The study is for patients who are not eligible for other clinical trials with VELCADE and for who VELCADE would otherwise not be available.

NCT ID: NCT00071708 No longer available - Clinical trials for Major Depressive Disorder

Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial

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

The primary objective of this study is to provide duloxetine to investigators for the treatment of patients who have previously participated in neuroscience duloxetine clinical trials and for whom effective alternative therapy is not available.

NCT ID: NCT00076960 No longer available - Neonatal Jaundice Clinical Trials

Compassionate Use of Stanate (TM) [Stannsoporfin]

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

The purpose of this protocol is to make Stanate (TM) [stannsoporfin, tin-mesoporphyrin] available to infants who meet the following criteria: 1. the infant has a very high level of bilirubin without an adequate clinical response to phototherapy; 2. the infant requires an exchange transfusion; and 3. the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community.

NCT ID: NCT00149981 No longer available - Clinical trials for Organ Transplantation

A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation

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

Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties

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: NCT00244686 No longer available - Clinical trials for Hypereosinophilic Syndrome

This Record Contains Information About the Mepolizumab Compassionate Use (CU) Product Activities: 104317: CU and Long-Term Access Study of Mepolizumab in HES. 201956:A Long-term Access Programme for Subjects With Severe Asthma 112562: Expanded Access for Patients With Hypereosinophilic

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

104317: The market authorisation application for mepolizumab for the indication of hypereosinophilic syndrome (HES) was filed in 2008, but later the file was withdrawn due to outstanding questions from regulator's raised from the application. On the basis of sponsor's evaluation, participants with life-threatening HES who have documented failure (lack of efficacy or a contra-indication) to at least 3 standard HES therapies (compassionate use) and participants who have participated in a previous GSK sponsored study in HES (long-term access) can be consider for mepolizumab treatment where the country regulation permits. In this study, participants will receive mepolizumab in an open-labelled manner, and limited data will be collected to evaluate the long-term safety and efficacy of mepolizumab. 201956: This is a Long-term Access Programme (LAP) which aims to support provision of mepolizumab, until it is commercially available, to eligible subjects with severe asthma who participated in a GSK-sponsored mepolizumab clinical study in severe asthma. Eligible subjects will initiate mepolizumab within a 6-month period following the individual subject's last scheduled visit in their preceding clinical study. For each subject benefit versus risk will be assessed throughout the study to support continued treatment with mepolizumab. 112562: To provide a mechanism for expanded access to mepolizumab therapy for eligible patients with HES. Whenever possible, use of an investigational medicinal product by a patient as part of a clinical trial is preferable. However, when patient enrollment in a clinical trial is not possible (such as when the patient is not eligible for ongoing clinical trials or the patient is not able to attend investigational sites), appropriate patients may receive mepolizumab through expanded access. This expanded access protocol was designed to allow access to mepolizumab for HES patients with seriously debilitating or life-threatening disease that are not able to enroll in clinical trials, including those patients that have already participated in a mepolizumab clinical trial.

NCT ID: NCT00419367 No longer available - Clinical trials for Lymphoma, T-Cell, Cutaneous

Compassionate Use of Vorinostat for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma (0683-042)

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

In an effort to allow patients continued access to vorinostat outside of the base study, patients that are actively receiving study medication will discontinue from this study and receive vorinostat via another method supported by the SPONSOR (e.g. Named Patient Program (NPP)). For those institutions that do not allow receipt of an investigational therapy outside of a clinical trial, patients that are actively receiving study medication and continue to meet eligibility will transition to an extension phase of the study and the base study will be closed. The extension phase will begin as soon as the protocol amendment is implemented.

NCT ID: NCT00495066 No longer available - Melanoma Clinical Trials

Compassionate Use Trial for Unresectable Melanoma With Ipilimumab

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

The primary objective of the study is to provide treatment with Ipilimumab to subjects who have serious or immediately life-threatening unresectable Stage III or Stage IV melanoma, who have no alternative treatment options, and whose physicians believe, based upon available data on benefit and risk, that it is appropriate to administer Ipilimumab at a dose of 3 mg/kg induction (with re-induction, if eligible), or for eligible subjects previously enrolled in Ipilimumab studies CA184-042, CA184-078, CA184-087, MDX010-16, or MDX010-20.

NCT ID: NCT00508963 No longer available - Clinical trials for Leishmaniasis, Cutaneous

Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis

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

Patients with biopsy proven new world cutaneous or mucocutaneous leishmaniasis will be treated with sodium stibogluconate (Pentostam).

NCT ID: NCT00511771 No longer available - Clinical trials for Chronic Idiopathic Constipation

A Treatment Investigational New Drug (tIND) Program of Tegaserod in Women With Irritable Bowel Syndrome With Constipation or With Chronic Idiopathic Constipation

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

To provide tegaserod to eligible women adult patients who did not have satisfactory improvement of their irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) symptoms with other available treatment(s) and / or patients who had satisfactory improvement of their symptoms with prior tegaserod treatment for IBS-C or CIC.