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PRO95780

Phase 2

Non-Hodgkin's Lymphoma | Small molecule | Oncology |Roche Holding AG|Trials Updated: Jun 6, 2017

PRO95780 development status

Highest phase Phase 2
Registered trials 5 across 1 sponsor since May 2007

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

PRO95780 clinical trials

PRO95780 · 1 trial · 1 indication

Phase 2 1
NCT00517049A Study of PRO95780 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy (APM4083g)Non-Hodgkin's Lymphoma
COMPLETED49 Analytics
PHASE2COMPLETED
A Study of PRO95780 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy (APM4083g)
Non-Hodgkin's LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective response, as determined by independent review facility
8 months

Secondary Endpoints

Progression-free survival, as determined by independent review facility
up to 12 months
Duration of objective response, as determined by independent review facility
up to 10.3 months
Overall survival
Up to 18.5 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
PRO95780DRUGIntravenous repeating dose
rituximabDRUGIntravenous repeating dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Signed Informed Consent Form * Age ≥ 18 years * Diagnosis of follicular, CD20-positive B-cell NHL * Progression of disease after an objective response or stable disease lasting \> 6 months following completion of the most recent rituximab-containing regimen * Measurable diseas...

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Frequently asked questions about PRO95780

What is PRO95780 used for?

PRO95780 is an investigational small molecule being studied for the treatment of Non-Hodgkin's Lymphoma. It was evaluated specifically in patients whose disease had progressed following prior rituximab therapy, and it was tested in combination with rituximab in that setting.

Who is developing PRO95780?

PRO95780 is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical program evaluating the drug in Non-Hodgkin's Lymphoma, including the Phase 2 study that combined it with rituximab in patients previously treated with rituximab.

What phase is PRO95780 in?

PRO95780 is in Phase 2 development. It is an investigational agent and has not been approved by the FDA. The Phase 2 program in Non-Hodgkin's Lymphoma has been completed, and no trials of PRO95780 are currently listed as active.

What clinical trials is PRO95780 in?

PRO95780 has been studied in one clinical trial, NCT00517049, titled A Study of PRO95780 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy. That Phase 2 trial enrolled 49 patients, was uncontrolled, and has been completed.

Is PRO95780 FDA approved?

No. PRO95780 is an investigational drug and has not been approved by the FDA. It remains in clinical development at the Phase 2 stage, with its single completed trial in Non-Hodgkin's Lymphoma evaluating the combination of PRO95780 and rituximab in patients whose disease progressed after prior rituximab therapy.