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NCT ID: NCT04204928 Approved for marketing - Clinical trials for Non-Small Cell Lung Cancer

Pre-Approval Access Program (PAAP) for Pralsetinib (BLU-667) in Patients With Unresectable or Metastatic NSCLC or MTC

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

This is a global, multicenter, open-label pre-approval access program to provide access to pralsetinib (BLU-667) until such time that pralsetinib becomes available through other mechanisms or the Sponsor chooses to discontinue the program.

NCT ID: NCT04220203 Approved for marketing - Clinical trials for HER2-positive Breast Cancer

Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer

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

The purpose of this program is to provide access to tucatinib in the United States before FDA approval. Participants will receive a combination treatment of capecitabine, trastuzumab, and tucatinib. All treatments will be given on a 21 day cycle. To learn more about this program, contact Seattle Genetics' Medical Information (medinfo@seagen.com).

NCT ID: NCT04256265 Approved for marketing - Clinical trials for Muscular Atrophy, Spinal

An Expanded Access Program for Risdiplam in Participants With Spinal Muscular Atrophy (SMA)

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

This expanded access program (EAP) will provide access to risdiplam for eligible participants with Type 1 or Type 2 spinal muscular atrophy (SMA) before it is commercially available in the United States for the indication of SMA.

NCT ID: NCT04291937 Approved for marketing - Clinical trials for Small Cell Lung Cancer

A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA

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

This is an expanded access program in the USA to enable eligible patients with previously treated small cell lung cancer to access lurbinectedin treatment prior to FDA approval. Sites must apply to participate in the program. A medical doctor must assess whether the potential benefit outweighs the risk of the investigational therapy considering the program eligibility criteria and the individual patient's medical history.

NCT ID: NCT04300803 Approved for marketing - DLBCL Clinical Trials

Expanded Access Program for Tafasitamab (MOR00208) in R/R DLBCL

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

Expanded Access Program (EAP) to provide Tafasitamab (MOR208) to eligible patients with relapsed or refractory Diffuse Large B Cell Lymphoma. Access to MorphoSys´ EAP can be requested by contacting the respective CRO Clinigen (tafasitamab@clinigengroup.com).

NCT ID: NCT04320693 Approved for marketing - Clinical trials for Metastatic Triple-Negative Breast Carcinoma

Expanded Access for IMMU-132

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

This is an expanded access program (EAP) for eligible participants designed to provide access to IMMU-132.

NCT ID: NCT04323761 Approved for marketing - SARS-CoV2 Infection Clinical Trials

Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)

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

The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

NCT ID: NCT04334837 Approved for marketing - Clinical trials for Neuroendocrine Tumors

Copper Cu 64 Dotatate for the Detection, Localization and Monitoring of SSTR Expressing (NETs)

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

This is an open-label, multi-center expanded access program designed to provide access to Copper Cu 64 Dotatate for the detection, localization, and monitoring of NETs to patients that did not have access during the Phase 3 Trial.

NCT ID: NCT04337112 Approved for marketing - Clinical trials for Muscular Dystrophy, Duchenne

The Expanded Access Use of Viltolarsen in Duchenne Muscular Dystrophy With Confirmed Exon 53 Amenable Mutation

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

This is an open label expanded access program for boys, 3 to 12 years old, for the treatment of Duchenne muscular dystrophy (DMD) with confirmed mutation(s) in the dystrophin gene that is amenable to skipping of exon 53.

NCT ID: NCT04338360 Approved for marketing - COVID19 Clinical Trials

Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19

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

This expanded access program will provide access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.