Clinical trials: sponsored by Hoffmann-La Roche
Tumors
A Study of Atezolizumab in Advanced Solid Tumors
The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete…
- Trial name
- NCT02458638
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
- Where
- 48 sites in United States, Austria and 16 more
- Volunteers
- 474 people
- Sponsor
- Hoffmann-La Roche
Hemophilia A
A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors
This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially once weekly (QW) in pediatric participants with…
- Trial name
- HAVEN 2 (NCT02795767)
- Testing
- Emicizumab
- Where
- 28 sites in United States, Costa Rica and 8 more
- Volunteers
- 88 people
- Sponsor
- Hoffmann-La Roche
Diffuse Large B-Cell Lymphoma, Lymphoma Follicular
A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment consisting of atezolizumab in combination with either obinutuzumab + bendamustine…
- Trial name
- NCT02596971
- Testing
- Atezolizumab, Bendamustine, Cyclophosphamide
- Where
- 21 sites in United States, Australia and 1 more
- Volunteers
- 91 people
- Sponsor
- Hoffmann-La Roche
Solid Tumors
A Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Participants With Solid Tumors
This is a study to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab in participants with advanced solid tumors including the following cohorts: squamous cell carcinoma of the head and neck…
- Trial name
- NCT03264066
- Testing
- Cobimetinib, Atezolizumab, Atezolizumab Cohort 7
- Where
- 19 sites in United States, Belgium and 4 more
- Volunteers
- 87 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B Virus Infection
A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection
This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses in healthy volunteers (HV) and participants diagnosed with chronic hepatitis B…
- Trial name
- NCT03762681
- Testing
- RO7239958
- Where
- 14 sites in Bulgaria, Hong Kong and 5 more
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Observational Study of Pertuzumab Safety in Participants With Breast Cancer
This Phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) will evaluate the safety of pertuzumab in approximately 1000 participants with metastatic or locally unresectable…
- Trial name
- NCT02266173
- Testing
- Pertuzumab
- Where
- 37 sites in South Korea
- Volunteers
- 1,130 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer…
- Trial name
- SafeHER (NCT01566721)
- Testing
- Herceptin
- Where
- 437 sites in Albania, Algeria and 57 more
- Volunteers
- 2,577 people
- Sponsor
- Hoffmann-La Roche
B-Cell Chronic Lymphocytic Leukemia
A Study Evaluating the Safety of Tocilizumab in Addition to Standard of Care Premedication Given Before Obinutuzumab + Chlorambucil in Participants With Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) and Comorbidities
This multicenter, double-blind, randomized, placebo-controlled study will evaluate the safety of a single infusion of tocilizumab versus placebo, administered in addition to standard premedications (antipyretic, antihistamine…
- Trial name
- NCT02336048
- Testing
- Chlorambucil, Obinutuzumab, Standard Premedication
- Where
- 14 sites in Israel, Italy and 3 more
- Volunteers
- 38 people
- Sponsor
- Hoffmann-La Roche
HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane
This is a Phase IV, single-arm, multicenter, open-label clinical trial designed to assess the safety of trastuzumab emtansine in Indian patients with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic…
- Trial name
- NCT02658734
- Testing
- Trastuzumab emtansine
- Where
- 13 sites in India
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
Multiple Myeloma
A Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) Alone or in Combination With an Immunomodulatory Drug and/or Daratumumab in Participants With Multiple Myeloma (MM)
This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various immunomodulatory agents in participants with MM who have…
- Trial name
- NCT02431208
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Daratumumab, Lenalidomide
- Where
- 31 sites in United States
- Volunteers
- 85 people
- Sponsor
- Hoffmann-La Roche
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
A Study to Characterize the Disease Behavior of Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD) During the Peri-Diagnostic Period
This international clinical study will enroll participants with a suspected diagnosis of IPF/ILD. This study will characterize the disease behavior of IPF and ILD in the peri-diagnostic period.
- Trial name
- NCT03261037
- Testing
- Spirometry, Accelerometry, 6MWT
- Where
- 37 sites in Canada, France and 4 more
- Volunteers
- 178 people
- Sponsor
- Hoffmann-La Roche
Autism Spectrum Disorder
A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers
This study will investigate the effect of food and the effect of esomeprazole on the pharmacokinetics (PK) of a single dose of balovaptan in healthy volunteers.
- Trial name
- NCT04156646
- Testing
- Balovaptan, Esomeprazole
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Muscular Atrophy, Spinal
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety and Tolerability of a Single Oral Dose of Risdiplam Compared to Matched Healthy Participants With Normal Hepatic Function
This is a multi-center, open-label, non-randomized, parallel-group, 2-part study to evaluate the effect of hepatic impairment on the PK and safety and tolerability of a single oral dose of risdiplam compared to matched healthy…
- Trial name
- NCT03920865
- Testing
- Risdiplam
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy
This Phase II, double-blind, randomized, placebo-controlled multicenter study will investigate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab or atezolizumab-placebo in participants with…
- Trial name
- KATE2 (NCT02924883)
- Testing
- Atezolizumab, Trastuzumab emtansine
- Where
- 68 sites in United States, Australia and 7 more
- Volunteers
- 202 people
- Sponsor
- Hoffmann-La Roche
Schizophrenia
A Study to Evaluate the Effects of Basmisanil in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS) Treated With Antipsychotics
This multicenter study assessed the effects of 24 weeks of basmisanil treatment on cognition and functioning of stable schizophrenia participants treated with antipsychotics.
- Trial name
- NCT02953639
- Testing
- Basmisanil
- Where
- 37 sites in United States
- Volunteers
- 214 people
- Sponsor
- Hoffmann-La Roche
Autism Spectrum Disorder
A Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Participants With Autism Spectrum Disorder (ASD)
For participants enrolled prior to Version 6 of the protocol: This was a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and…
- Trial name
- NCT02901431
- Testing
- RO5285119
- Where
- 45 sites in United States
- Volunteers
- 339 people
- Sponsor
- Hoffmann-La Roche
Non-small Cell Lung Cancer (NSCLC)
A Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-Doublet Chemotherapy in Participants Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-Small Cell Lung Cancer
This study will evaluate the efficacy, safety, pharmacokinetics, immunogenicity and biomarkers of RO7198457 plus atezolizumab compared with atezolizumab alone in patients with Stage II-III non-small cell lung cancer (NSCLC) who…
- Trial name
- NCT04267237
- Testing
- Atezolizumab, RO7198457
- Sponsor
- Hoffmann-La Roche
Sarcoma
A Study of R1507 in Participants With Recurrent or Refractory Sarcoma
The study was primarily designed to determine objective response, progression-free survival (PFS), and the safety and tolerability of R1507 in participants with recurrent or refractory Ewing's sarcoma, osteosarcoma, synovial…
- Trial name
- NCT00642941
- Testing
- RG1507
- Where
- 41 sites in United States, Australia and 9 more
- Volunteers
- 317 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Gastric Cancer
A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC)
This multicenter study will assess the maximum tolerated dose (MTD) of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase 1 design…
- Trial name
- TRAXHER2 (NCT01702558)
- Testing
- Capecitabine, Trastuzumab emtansine (T-DM1)
- Where
- 40 sites in Argentina, Brazil and 10 more
- Volunteers
- 182 people
- Sponsor
- Hoffmann-La Roche
Lung Diseases, Interstitial
A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease
The purpose of this study is to evaluate the efficacy and safety of pirfenidone in participants with fibrosing interstitial lung disease (ILD) who cannot be classified with moderate or high confidence into any other category of…
- Trial name
- NCT03099187
- Testing
- Pirfenidone
- Where
- 66 sites in Australia, Belgium and 12 more
- Volunteers
- 253 people
- Sponsor
- Hoffmann-La Roche
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