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NCT01660451 · ClinicalTrials.gov registry record · Phase 2
Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 227
- Enrollment target
NCT01660451 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 227 participants.
The verdict
NCT01660451, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 227 participants
- Enrollment target
Study Summary
The objective of the study (part A) is to evaluate the efficacy and safety of BAY80-6946 in patients with indolent or aggressive Non-Hodgkin's Lymphoma, who have progressed after standard therapy. 30 patients will be enrolled to both indolent and aggressive disease group. The objective of the study part B (CHRONOS-1) is to evaluate the efficacy and safety of BAY80-6946 in patients with relapsed/refractory follicular lymphoma. 120 patients will be enrolled in the part B of the study. Further objectives are to evaluate the pharmacokinetics and biomarkers. Quality of life will be a further objective of part B of the study. In a cohort of 20 patients (enrolled both in part A and B) an ECG substudy will be performed to assess the potential for cardiac toxicity and QT/QTc interval prolongation of BAY80-6946. After an up to 28-day screening period, eligible patients will start treatment with BAY80-6946 at a dose of 0.8 mg/kg (Part A) and at a dose of 60 mg (Part B). Treatment will be continued until disease has progressed or until another criterion is met for withdrawal from study. An end-of-treatment visit will be performed within 7 days after discontinuation of study treatment. Thirty to 35 days after last study drug administration, a safety followup visit will be performed for the collection of adverse events (AEs) and concomitant medication data. Patients will be contacted quarterly to determine overall survival status up to 4 years after last patient completed treatment. Patients who discontinue study drug for reasons other than disease progression will enter the Active Assessment Follow-up period. The end of study notification to Health Authorities will be based on the completion of the collection of survival data. The efficacy is measured by the decrease in tumor size. Tumor assessments will be done at Screening, every 8 weeks during Year 1, every 12 weeks during Year 2, and every 6 months during Year 3. Blood samples will be collected for pharmacokinetic analys
Interventions
- DRUG Copanlisib (Aliqopa, BAY80-6946)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2012-11-19 |
| Est. Completion | 2023-05-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01660451
The ClinicalTrials.gov registry entry for NCT01660451 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 227 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Copanlisib (Aliqopa, BAY80-6946) is the first listed.
NCT01660451 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01660451 about?
NCT01660451 is a clinical study titled "Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas". The objective of the study (part A) is to evaluate the efficacy and safety of BAY80-6946 in patients with indolent or aggressive Non-Hodgkin's Lymphoma, who have progressed after standard therapy. 30 patients will be enrolled to both indolent and aggressive disease group. The objective of the study ...
What is the current status of trial NCT01660451?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 227 participants. The study started on 2012-11-19. Estimated completion is 2023-05-18.
What interventions are being tested in trial NCT01660451?
The interventions under investigation include: Copanlisib (Aliqopa, BAY80-6946) (DRUG).
Who is sponsoring clinical trial NCT01660451?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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