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NCT ID: NCT03906331 Available - Breast Cancer Clinical Trials

Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

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

Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial. The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

NCT ID: NCT03994627 Available - Soft Tissue Sarcoma Clinical Trials

Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma

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

The purpose of this study is to continue to provide olaratumab to eligible patients who are currently receiving olaratumab commercially for the treatment of soft tissue sarcoma (STS).

NCT ID: NCT04008524 Available - Clinical trials for Relapsed and Refractory Hematological Malignancies

A Clinical Study of CAR-T Cells in the Treatment of Relapsed and Refractory Hematological Malignancies

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

This project is intended to provide CAR-T cell therapy products for patients with severely life-threatening relapsed and refractory hematological malignancies. These patients have been previously treated sufficiently, currently have no other treatment methods available, and do not meet the inclusion criteria of other clinical trial projects in the process of subject recruitment or meet their exclusion criteria. This project is designed to meet the urgent clinical needs of individual patients.

NCT ID: NCT04040660 Available - Thermal Burn Clinical Trials

Use of NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries

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

Enzymatic eschar removal with NexoBrid allows initiating and completing the phase of removal of the offending eschar earlier upon admission, enabling earlier visualization of the wound bed for assessment of burn wound depth as well as preservation of viable dermal tissues, as further elaborated and supported by previous clinical studies. The depth determination is important for the planning and execution of the post eschar removal stage of wound closure phase (grafting or spontaneous epithelialization). Additional clinically meaningful attributes of NexoBrid enzymatic eschar removal is the ability to lower surgical burden as it allows to remove eschar in wounds that otherwise would have to undergo surgical excision as no other non-surgical treatment is available for early and effective eschar removal. MediWound has completed the recruitment of patients to study MW2010-03-02 (DETECT Study). The timeline for patients' follow-up and potential for approval in 2021/2022, creates a significant gap in the ability of clinical practitioner's to maintain their knowledge and skills in using NexoBrid as they no longer treat eligible patients. The expanded access protocol will allow to expand treatment to additional patients in up to 30 US burn centers (DETECT sites and additional sites), until the completion of the BLA assessment and possible marketing authorization of NexoBrid in the US. The proposed protocol will allow product availability to eligible population and keep the clinical use of the product knowledge active in the burn care community introducing it to their routine burn care. The purpose of this treatment protocol is to provide NexoBrid to patients with DPT and FT thermal burns on up to 30% TBSA. This protocol is also designed to collect and evaluate the safety and clinical performance of NexoBrid in this patient population.

NCT ID: NCT04060628 Available - Clinical trials for Urogenital Neoplasms

Expanded Access to NanoDoce

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

NanOlogy may consider offering expanded access to NanoDoce for patients who do not meet the enrollment criteria of clinical trials in progress.

NCT ID: NCT04074512 Available - Menkes Disease Clinical Trials

Copper Histidinate Treatment for Menkes Disease

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

This study investigates the clinical effects and safety of subcutaneous Copper Histidinate treatment for newly diagnosed Menkes disease patients under 6 years of age.

NCT ID: NCT04081714 Available - Clinical trials for Amyotrophic Lateral Sclerosis

Intermediate Expanded Access Protocol for ALS

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

This is a single-center intermediate expanded access program to provide access to the investigational product, CNM-Au8, up to 40 participants diagnosed with ALS.

NCT ID: NCT04085653 Available - Clinical trials for PIK3CA-Related Overgrowth Spectrum (PROS)

Managed Access Program (MAP) to Provide Access to Alpelisib (BYL719) for Patients With PIK3CA-Related Overgrowth Spectrum (PROS)

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

The purpose of this Cohort Treatment Plan is to allow access to alpelisib for patients diagnosed with PIK3CA-Related Overgrowth Spectrum (PROS) who fulfill certain eligibility criteria as specified in this document. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations

NCT ID: NCT04087876 Available - Clinical trials for Intrahepatic Cholangiocarcinoma

Expanded Access Use of Derazantinib for Advanced Intrahepatic Cholangiocarcinoma (iCCA) With FGFR Genomic Alterations

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

Basilea is providing expanded access to derazantinib for patients with locally advanced, inoperable or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR genomic alterations on a patient by patient basis while clinical development of derazantinib is ongoing.

NCT ID: NCT04091295 Available - Pancreatic Cancer Clinical Trials

BLESSED: Expanded Access for DeltaRex-G for Advanced Pancreatic Cancer, Sarcoma and Carcinoma of Breast

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

Forty patients with pancreatic cancer, sarcoma and carcinoma of breast will receive DeltaRex-G intravenously at a dose of 1-4 x 10e11 colony forming units (cfu) or equivalent 0.6-1.8 x 10e10 RV copies per dose one to three times a week. DeltaRex-G may be given alone or with one or more FDA approved cancer therapies/immunotherapies. Based on previous Phase 1/2 US based clinical studies, DeltaRex-G does not suppress the bone marrow or cause serious organ dysfunction, and enhanced immune cell trafficking in tumors may cause the tumors to appear larger or new lesions to appear on CT, PET or MRI. Further, tumor stabilization/regression/remission may occur later during the treatment period. Therefore, DeltaRex-G will be continued regardless of CT, PET or MRI results if the patient has clinical benefit and does not have symptomatic disease progression.