Oncopeptides AB
Expanded Access Program for Melphalan Flufenamide (Melflufen) in Triple Class Refractory Multiple Myeloma
Conditions: Relapsed and/or Refractory Multiple Myeloma
To provide early treatment access and evaluate the safety of melflufen and dexamethasonein patients with triple class refractory (TCR) multiple myeloma (MM).
Clinigen, Inc.
A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)
Conditions: Alagille Syndrome
An open-label, single-arm, multi-centre program providing treatment access to ALGSpatients with cholestatic pruritus in the US. Access can be requested through ClinigenHealthcare Ltd via email MirumALGS@clinigengroup.com or telephone +1-877-768-4303.
Leonard-Meron Biosciences, Inc.
Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
Conditions: Catheter-Related Infections
This is an Intermediate-Size Expanded Access, Open-Label Study for Use of Mino-LokTherapy (MLT) in Combination with Systemic Antibiotics in the Treatment of Central LineAssociated Bloodstream Infection. Mino-Lok may be made available for patients whootherwise do not qualify for the phase 3 clinical trial (NCT02901717 )
Taiho Oncology, Inc.
Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
Conditions: Advanced Cholangiocarcinoma
The objective of the study is to provide access to TAS-120 to patients With AdvancedCholangiocarcinoma Harboring FGFR2 Gene Rearrangements.
Albireo
Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis
Conditions: Progressive Familial Intrahepatic Cholestasis
To provide treatment access to patients with PFIC in the US who have pruritus andelevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for thefollowing reasons: 1) Do not meet eligibility criteria for PEDFIC 2; 2) Are not able toget to a PEDFIC 2 site for geographical reasons, and 3) Do meet the eligibility criteriafor PEDFIC 2 after recruitment has been completed
Vanda Pharmaceuticals
Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
Conditions: Gastroparesis, Diabetic Gastroparesis
Primary Objective: To treat a single patient with gastroparesis who has requestedexpanded access with tradipitant
Genentech, Inc.
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
Conditions: HER2-positive Breast Cancer
This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dosecombination formulation for subcutaneous injection (PH FDC SC) administered at home by ahome health nursing provider for patients with human epidermal growth factor receptor2-positive (HER2+) breast cancer who have completed concurrent chemotherapy withpertuzumab (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 FDCSC, or trastuzumab SC in the clinic. The main objective is to enable continuity of careduring 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 andcontinue treatment unless early cessation is necessary due to disease recurrence, diseaseprogression, unacceptable toxicity, participant withdrawal of consent, or per physician'srecommendation. Participants with early HER2+ breast cancer will receive PH FDC SC tocomplete 1 year (up to 18 cycles) of dual blockade, including the P+H IV, PH FDC SC, ortrastuzumab SC they received prior to enrolling in this study, unless early cessation isnecessary 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 selectsites.The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer arisk for this patient population.
Celgene
Expanded Access for CC-486
Conditions: Acute Myelogenous Leukemia (AML)
This is an expanded access program (EAP) for eligible participants designed to provideaccess to CC-486.
Jazz Pharmaceuticals
An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer
Conditions: HER2-Positive Advanced Biliary Tract Cancer
This is an intermediate-size Expanded Access Protocol (EAP) for use of zanidatamab (ZW25)in patients with human epidermal growth factor receptor 2 (HER2)-positive advancedbiliary tract cancer (BTC) who are not eligible for other zanidatamab clinical trials,and who in the opinion of the treating oncologist, would potentially benefit fromtreatment with zanidatamab.
Advanced Accelerator Applications
EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx
Conditions: Neuroendocrine Tumors
Advanced Accelerator Applications is currently pursuing marketing approval for177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aimsto allow patients suffering from inoperable, somatostatin receptor positive,neuroendocrine tumors, progressive under somatostatin analogue therapy to access theinvestigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercialavailability.