Clinical trials: sponsored by Hoffmann-La Roche
Healthy
Compare Bioavailability of RO7239361 After Subcutaneous Injection
Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected into the arm, thigh, or the stomach. Collect data on safety of RO7239361.
- Trial name
- NCT03100630
- Testing
- RO7239361
- Where
- United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Non-Small Cell Lung Cancer
A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor (HER)2 Immunohistochemistry (IHC)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
This is a Phase 2, multicenter study designed to evaluate the efficacy and safety of trastuzumab emtansine administered as a single-agent in participants with HER2-positive (HER2 IHC 2+ or HER2 IHC 3+) advanced or metastatic…
- Trial name
- NCT02289833
- Testing
- Trastuzumab Emtansine
- Where
- 23 sites in United States, Germany and 5 more
- Volunteers
- 49 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteer
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Participants
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of single and multiple oral doses of GDC-0853 in healthy Japanese and Caucasian subjects.
- Trial name
- NCT03188783
- Testing
- GDC-0853
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Non-Hodgkin's Lymphoma
A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab
This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with…
- Trial name
- MabCute (NCT01461928)
- Testing
- Chemotherapy (Induction Period), Rituximab
- Where
- 180 sites in Albania, Argentina and 22 more
- Volunteers
- 692 people
- Sponsor
- Hoffmann-La Roche
Bladder Cancer
A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]
This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or…
- Trial name
- NCT02302807
- Testing
- Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody, Docetaxel, Paclitaxel
- Where
- 217 sites in United States, Australia and 27 more
- Volunteers
- 931 people
- Sponsor
- Hoffmann-La Roche
Coronary Heart Disease
A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)
This double-blind, randomized, placebo-controlled, multi-center study will evaluate the safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome (ACS).
- Trial name
- NCT01323153
- Testing
- dalcetrapib
- Where
- 33 sites in United States, Czechia and 2 more
- Volunteers
- 300 people
- Sponsor
- Hoffmann-La Roche
Malignant Melanoma
A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma
This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600 mutation-positive metastatic melanoma.
- Trial name
- NCT01271803
- Testing
- Cobimetinib, vemurafenib
- Where
- 10 sites in United States, Australia
- Volunteers
- 131 people
- Sponsor
- Hoffmann-La Roche
Ovarian Cancer
BELOVA Data Collection: Safety and Efficacy of Frontline Bevacizumab Treatment in Participants With Ovarian Cancer 70 Years and Older
The purpose of this study is to evaluate the safety and efficacy in the frontline treatment of ovarian cancer in participants 70 years of age and older in routine clinical practice in Belgium.
- Trial name
- NCT02393898
- Testing
- Bevacizumab, Carboplatin, Paclitaxel
- Where
- 26 sites in Belgium
- Volunteers
- 76 people
- Sponsor
- Hoffmann-La Roche
Melanoma
A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for…
- Trial name
- BRIM8 (NCT01667419)
- Testing
- Vemurafenib
- Where
- 207 sites in United States, Argentina and 27 more
- Volunteers
- 498 people
- Sponsor
- Hoffmann-La Roche
Solid Tumor
An Extension Study of Onartuzumab in Participants With Solid Tumors on Study Treatment Previously Enrolled in a Company Sponsored Study
This extension study will provide continued onartuzumab and/or parent trial (P-trial) designated control treatments to participants with cancer who were previously enrolled in a company-sponsored onartuzumab P-trial and who…
- Trial name
- NCT02488330
- Testing
- Onartuzumab, Bevacizumab, Erlotinib
- Where
- 10 sites in France, Italy and 6 more
- Volunteers
- 12 people
- Sponsor
- Hoffmann-La Roche
Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell
A Study to Assess Programmed Death Ligand-1 (PD-L1) Expression in Cytological Versus Histological Lung Cancer Specimens
The primary purpose of this non-interventional, multinational study is to assess the feasibility of assessing PD-L1 protein expression on cytological samples as a surrogate for histological samples obtained from participants with…
- Trial name
- NCT03092739
- Testing
- PD-L1 Immunocytochemistry (ICC), PD-L1 Immunohistochemistry (IHC)
- Where
- 8 sites in Czechia, Germany and 4 more
- Volunteers
- 184 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study to Assess the Feasibility of an E-Health System (ZEMY) Designed to Manage Symptoms in Participants With Breast Cancer Under Anti-Cancer Treatment
This is a three-month open-label, multicenter, interventional, single arm study located in France, designed to assess feasibility and reliability of the e-Health ZEMY software medical device under investigation for use by…
- Trial name
- ZEMY (NCT03558490)
- Testing
- ZEMY software, Investigator's choice of anti-cancer treatment (except immunotherapy)
- Where
- 5 sites in France
- Volunteers
- 56 people
- Sponsor
- Hoffmann-La Roche
Renal Anemia of Chronic Kidney Disease
A Study to Assess Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Participants Not in Dialysis Treated With Methoxy Polyethylene Glycol-Epoetin Beta (COMETE)
This prospective, multicenter, observational study will evaluate the impact of comorbidity factors on the hemoglobin level in participants with chronic kidney disease who are not on dialysis and initiated on treatment with…
- Trial name
- NCT01756612
- Testing
- Methoxy Polyethylene Glycol-Epoetin Beta
- Where
- 108 sites in France
- Volunteers
- 551 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms
A Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
This is a randomized, multicenter, open-label, two-arm study in treatment-naive participants with operable, locally advanced, or inflammatory, centrally-assessed HER2-positive early breast cancer (EBC) whose primary tumors were…
- Trial name
- NCT02131064
- Testing
- Carboplatin, Docetaxel, Pertuzumab
- Where
- 79 sites in United States, Belgium and 8 more
- Volunteers
- 444 people
- Sponsor
- Hoffmann-La Roche
Granulomatosis With Polyangiitis
A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with severe granulomatosis with polyangiitis (GPA)…
- Trial name
- NCT01750697
- Testing
- Rituximab
- Where
- 23 sites in United States, Canada and 6 more
- Volunteers
- 25 people
- Sponsor
- Hoffmann-La Roche
Geographic Atrophy
A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy…
- Trial name
- CHROMA (NCT02247479)
- Testing
- Lampalizumab
- Where
- 145 sites in United States, Argentina and 17 more
- Volunteers
- 906 people
- Sponsor
- Hoffmann-La Roche
Anemia, Kidney Disease, Chronic
A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis
This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target hemoglobin concentration of 11-12…
- Trial name
- ALTITUD (NCT01519947)
- Testing
- Methoxy polyethylene glycol-epoetin beta
- Where
- 7 sites in Mexico
- Volunteers
- 87 people
- Sponsor
- Hoffmann-La Roche
Solid Tumors
A Study to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Participants With Solid Tumors
This multi-center, open-label, pharmacokinetic study will evaluate the bioequivalence (BE) or relative bioavailability (rBA) of three new idasanutlin-tablet variants compared to the reference tablet formulation following oral…
- Trial name
- NCT03362723
- Testing
- Idasanutlin
- Where
- 11 sites in United States, Canada
- Volunteers
- 48 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteer
A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants
The purpose of this randomized, open-label, parallel-group, placebo-controlled study is to assess pain following subcutaneous (SC) administration of gantenerumab as a high-concentration liquid formulation (HCLF) at different…
- Trial name
- NCT02882009
- Testing
- Gantenerumab
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Macular Edema, Macular Degeneration
Study to Evaluate Home Vision Testing in Participants Who Receive Ranibizumab (Lucentis®)
This pilot study will evaluate home vision testing using a mobile medical application in participants with diabetic macular edema (DME) or neovascular age-related macula degeneration (nAMD) who receive intravitreal ranibizumab…
- Trial name
- NCT02420132
- Testing
- Ranibizumab
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Hoffmann-La Roche
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