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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
Continuous dosing of BAY73-4506 in patients with advanced cancer
Eligible Conditions
- Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AUC From Time 0 to 24 Hours at Steady State(AUC(0-24),ss)
Area Under the Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose (AUC)
Cmax at Steady State During a Dosing Interval (Cmax,ss)
+2 moreSecondary study objectives
AUC From Time 0 to 24 Hours at Steady State Divided by Dose (AUC(0-24)ss/D)
AUC From Time 0 to the Last Data Point > Lower Limit of Quantification (LLOQ) (AUC(0-tlast))
Area Under the Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose Divided by Dose (AUC/D)
+11 moreOther study objectives
Tumor Progression in Dose Escalation Cohort
Tumor Progression in Expansion Cohort
Tumor Response in Dose Escalation Cohort
+1 moreAwards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Arm 8Experimental Treatment1 Intervention
Group II: Arm 7Experimental Treatment1 Intervention
Group III: Arm 6Experimental Treatment1 Intervention
Group IV: Arm 5Experimental Treatment1 Intervention
Group V: Arm 4Experimental Treatment1 Intervention
Group VI: Arm 3Experimental Treatment1 Intervention
Group VII: Arm 2Experimental Treatment1 Intervention
Group VIII: Arm 1Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
FDA approved
Regorafenib
FDA approved
Regorafenib
FDA approved
Regorafenib
FDA approved
Regorafenib
FDA approved
Regorafenib
FDA approved
Regorafenib
FDA approved
Regorafenib
FDA approved
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,275 Previous Clinical Trials
25,539,313 Total Patients Enrolled
4 Trials studying Tumors
1,597 Patients Enrolled for Tumors
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,780 Total Patients Enrolled
2 Trials studying Tumors
25 Patients Enrolled for Tumors
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