By webmin on
Phone
(844) 287-3783
Email
N/A
ClinicalTrials.gov URL
https://clinicaltrials.gov/ct2/results?cond=&term=Genentech&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=d
Acknowledgement
3 business days
EA Page
https://www.gene.com/patients/investigational-medicines
Sponsor
Genentech, Inc.
EA Policies for Single Patient

https://www.gene.com/patients/clinical-trial-information/other-types-of-access#general-criteria

COVID-19 Information

Genentech Announces FDA Approval of Clinical Trial for Actemra to Treat Hospitalized Patients With Severe COVID-19 Pneumonia

Genentech Initiates Phase III Clinical Trial Of Actemra In Hospitalized Patients With Severe COVID-19 Pneumonia

COVID-19 response page

On March 23, 2020, we announced that the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase III clinical trial (COVACTA) in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of intravenous Actemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia. Learn more about the COVACTA clinical trial here.

Additionally, to further support U.S. COVID-19 response efforts, Genentech will provide 10,000 vials of Actemra to the U.S. Strategic National Stockpile for potential future use at the direction of the U.S. Department of Health and Human Services (HHS).

Multiple ongoing clinical trials involving Actemra (tocilizumab). For a list, go to: https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=tocilizumab&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k

Stage
Phase 3
Company Type
Late Onset Intervention
Expanded Access Listings

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.

A Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Conditions
Basal Cell Carcinoma

This is an open-label, non-comparative, multicenter, expanded access study of Vismodegib(GDC-0449) in patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC(mBCC) who are otherwise without satisfactory treatment options.

An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy

Conditions
Urothelial Carcinoma

This is an open-label, multicenter, single-arm, expanded access program (EAP) designed toprovide atezolizumab access to participants with locally advanced or metastaticurothelial carcinoma that has progressed on, or is intolerant to, a platinum-containingchemotherapy regimen.

An Expanded Access Program of Emicizumab in Participants With Hemophilia A With Inhibitors

Conditions
Hemophilia A

This open-label, multicenter expanded access program (EAP) is designed to provideemicizumab to eligible participants with hemophilia A with factor VIII (FVIII) inhibitorsbefore it is commercially available in the United States for the indication of hemophiliaA with FVIII inhibitors. Discontinuation may occur earlier if participant or physiciandecides to discontinue treatment or the sponsor discontinues emicizumab clinicaldevelopment.

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

Conditions
Muscular Atrophy, Spinal

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