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NCT ID: NCT04348682 Approved for marketing - Prostate Cancer Clinical Trials

Expanded Access Protocol of 68Ga-PSMA-11 for PET Imaging

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

To provide expanded access to 68Ga-PSMA-11 PET imaging for eligible participants to detect and localize prostate cancer for initial and subsequent treatment strategy.

NCT ID: NCT04377152 Approved for marketing - Prostate Cancer Clinical Trials

Expanded Access 68Gallium-PSMA-11 PET for Prostate Cancer

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

This expanded access protocol provides eligible participants with investigational 68Ga-PSMA-11 PET imaging to detect and localize prostate cancer for initial and subsequent treatment strategy.

NCT ID: NCT04395508 Approved for marketing - Clinical trials for HER2-positive Breast Cancer

An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic

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

This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dose combination formulation for subcutaneous injection (PH FDC SC) administered at home by a home health nursing provider for patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer who have completed concurrent chemotherapy with pertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV) and are currently receiving or will be receiving maintenance therapy with P+H IV, PH FDC SC, or trastuzumab SC in the clinic. The main objective is to enable continuity of care during the COVID-19 pandemic. This study will enroll approximately 200 patients in the United States. Participants with early or metastatic HER2+ breast cancer will be enrolled in this study. Participants with metastatic HER2+ breast cancer will receive treatment every 3 weeks and continue treatment unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity, participant withdrawal of consent, or per physician's recommendation. Participants with early HER2+ breast cancer will receive PH FDC SC to complete 1 year (up to 18 cycles) of dual blockade, including the P+H IV, PH FDC SC, or trastuzumab SC they received prior to enrolling in this study, unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity, participant withdrawal of consent, or per physician's recommendation. A remote cardiac surveillance substudy will be optional for patients enrolled at select sites. The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer a risk for this patient population.

NCT ID: NCT04428632 Approved for marketing - Clinical trials for Hereditary Angioedema

Oral Berotralstat Expanded Access Program

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

This expanded access program will provide access to berotralstat for eligible participants with hereditary angioedema in the U.S.

NCT ID: NCT04452136 Approved for marketing - Prostate Cancer Clinical Trials

Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer

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

This study provides expanded access to radiotracer Gallium 68 (68Ga)-prostate-specific membrane antigen (PSMA)-HBED-CC (68Ga-PSMA-11) with Positron Emission Tomography (PET) imaging for participants with intermediate and high risk prostate cancer before prostatectomy or for suspected biochemical recurrence of their prostate cancer. Compared to conventional imaging, 68Ga PSMA-HBED-CC might improve the ability to localize the sites of recurrent or metastatic disease, which helps with surgical and other treatment planning.

NCT ID: NCT04483531 Approved for marketing - Clinical trials for Progressive Familial Intrahepatic Cholestasis

Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis

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

To provide treatment access to patients with PFIC in the US who have pruritus and elevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for the following reasons: 1) Do not meet eligibility criteria for PEDFIC 2; 2) Are not able to get to a PEDFIC 2 site for geographical reasons, and 3) Do meet the eligibility criteria for PEDFIC 2 after recruitment has been completed

NCT ID: NCT04504513 Approved for marketing - Clinical trials for Small Cell Lung Cancer

Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer

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

The purpose of this expanded access protocol is to provide access to trilaciclib for chemotherapy-induced myelosuppression in patients receiving chemotherapy as a treatment for small cell lung cancer (SCLC). Patients will receive trilaciclib intravenously as a 30-minute infusion prior to chemotherapy dosing and on each day that chemotherapy is administered. Supplementary to providing access to trilaciclib, this expanded access program will also capture Real World Data to help inform subsequent trilaciclib development. Requests for access to trilaciclib will be managed by Bionical Emas. G1 Therapeutics will review eligibility of, as well as complete a medical review of, each patient access request.

NCT ID: NCT04507503 Approved for marketing - Clinical trials for Advanced Cholangiocarcinoma

Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

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

The objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.

NCT ID: NCT04513860 Approved for marketing - Partial Epilepsy Clinical Trials

Cenobamate Expanded Access Program (EAP)

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

This Cenobamate Expanded Access Program (EAP) is designed to continue providing treatment with Cenobamate (YKP3089) to patients with partial-onset epilepsy that were enrolled in the SK Life Science clinical trial YKP3089C013, YKP3089C017 or YKP3089C021.

NCT ID: NCT04530994 Approved for marketing - Alagille Syndrome Clinical Trials

A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)

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

An open-label, single-arm, multi-centre program providing treatment access to ALGS patients with cholestatic pruritus in the US. Access can be requested through Clinigen Healthcare Ltd via email MirumALGS@clinigengroup.com or telephone +1-877-768-4303.