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NCT ID: NCT04446793 No longer available - Clinical trials for Metastatic Colorectal Cancer

Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Mutated Metastatic Colorectal Cancer

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

This is an expanded access program for eligible participants designed to provide access to onvansertib in combination with FOLFIRI and bevacizumab.

NCT ID: NCT04452994 No longer available - Multiple Myeloma Clinical Trials

Individual Patient Investigational New Drug (IND) Expanded Access Program of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Participant With Multiple Myeloma

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

The purpose of this individual-patient investigational new drug (IND) single patient request (SPR) is to provide participants treatment with JNJ-68284528, an investigational product prior to its marketing authorization. Such access may be considered for participants with serious/life-threatening diseases or conditions, where there exists no alternative treatments or where alternative treatments have been exhausted.

NCT ID: NCT04453397 No longer available - Multiple Myeloma Clinical Trials

Expanded Access for TNB-383B in a Subject With Relapsed/Refractory Multiple Myeloma

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

This is a single patient protocol for TNB-383B in a subject with relapsed/refractory multiple myeloma (MM) who is not a candidate for treatment regimens known to provide clinical benefit in MM.

NCT ID: NCT04453839 No longer available - Clinical trials for Critical COVID-19 With Respiratory Failure

ZYESAMI (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE)

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

Patients with Critical COVID-19 and respiratory failure who are ineligible for enrollment in NCT04311697, who live more than 50 miles from an existing collaborating research center, or who are already hospitalized and cannot safely be transferred to a collaborating research facility may be considered for expanded access by the sponsor. Treating physicians must complete FDA Form 3396 and receive a letter of authorization from NeuroRx, along with local IRB authorization. Please refer to FDA guidance for Individual Patient Expanded Access https://www.fda.gov/media/91160/download

NCT ID: NCT04465929 No longer available - Clinical trials for Peripheral Nerve Injuries

Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair

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

Emergency expanded access for a single patient was granted to receive autologous human Schwann cell (ahSC) augmentation of nerve autograft repair after severe peripheral nerve injury (PNI).

NCT ID: NCT04472572 No longer available - COVID-19 Clinical Trials

Expanded Access to Convalescent Plasma for Treatment of COVID-19

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

This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center 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.

NCT ID: NCT04476706 No longer available - Clinical trials for Cytokine Release Syndrome in COVID-19-induced Pneumonia

Canakinumab MAP in COVID-19 Pneumonia With CRS

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

This is a global Managed Access Program (MAP) to provide access to canakinumab to patients with cytokine release syndrome resulting from COVID-19 pneumonia

NCT ID: NCT04484363 No longer available - Clinical trials for Myelodysplastic Syndromes

Expanded Access Program With Pevonedistat (Given With Azacitidine) for Adults With Higher-risk Myelodysplastic Syndromes

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

Participants in the expanded access program are adults with higher-risk myelodysplastic syndromes who have no other treatment options available. The main aim of this program is to allow participants to have access to pevonedistat before FDA approval. This program will take place in the United States.

NCT ID: NCT04498871 No longer available - Clinical trials for Hypereosinophilic Syndrome (HES)

MAP to Provide Access to Nilotinib, for Patients With HES

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

The purpose of this program is to allow access to nilotinib for eligible patients diagnosed with Hypereosinophilic syndrome (HES). The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations. The requesting Treating Physician submitted a request for access to drug (often referred to as Compassionate Use) to Novartis which was reviewed and approved by the medical team experienced with the drug and indication. Please refer to the latest Investigator's Brochure (IB) or approved label for overview of drug including: non-clinical and clinical experience, risk and benefits. Novartis will continue to provide any new safety information to the Treating Physician as they emerge.

NCT ID: NCT04501757 No longer available - Clinical trials for High-Risk Neuroblastoma

Naxitamab and GM-CSF in People With Neuroblastoma

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

This is an Expanded Access Program (EAP) that will give the participants access to the drug naxitamab before it is approved by the FDA. Naxitamab will be combined with granulocyte-macrophage colony stimulating factor (GM-CSF). Participants in this study will have high-risk neuroblastoma that either went away completely after treatment (complete remission) or has come back (relapsed/refractory). Researchers think the combination of naxitamab and GM-CSF will be effective because naxitamab and GM-CSF strengthen the immune system's response to cancer cells in different ways. Naxitamab is an antibody, like the proteins made by the immune system to protect the body from harm. Naxitamab helps the cells of the immune system to find and attack cancer cells. GM-CSF is a protein that strengthens the immune system by increasing the number of immune cells called granulocytes. Granulocytes are white blood cells that fight off cancer cells. The combination of naxitamab and GM-CSF is a type of immunotherapy.