check_circleStudy Completed
Neoplasms
Bayer Identifier:
12874
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Phase I study of PI3(phosphoinositol 3)-Kinase inhibitor BAY80-6946 with paclitaxel in patients with advanced cancer
Trial purpose
This open label Phase 1 study involves treating subjects with advanced cancer with BAY80-6946 in combination with paclitaxel. It will determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of BAY80-6946 in combination with paclitaxel. The trial will involve multiple participating sites from the US. Following determination of the MTD, an expansion cohort of 20 evaluable subjects with breast cancer was planned. Finally, 16 patients have been enrolled to treatment (Cohort 3). A new expansion cohort with modified dosing cohort is now introduced (Cohort 4: breast cancer expansion cohort with modified dosing) in which another 20 subjects are planned to be enrolled to treatment.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
55Trial Dates
August 2011 - June 2015Phase
Phase 1Could I Receive a placebo
NoProducts
Aliqopa (Copanlisib, BAY80-6946)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | St. Louis, 63110, United States | |
Terminated | New York, 10065, United States | |
Completed | Houston, 77030, United States |
Primary Outcome
- Adverse event collectiondate_rangeTime Frame:Up to 3 years or longer if indicatedenhanced_encryptionYesSafety Issue:
- Maximum tolerated dose, measured by adverse event profiledate_rangeTime Frame:Up to 3 years or longer if indicatedenhanced_encryptionYesSafety Issue:
- Pharmacokinetics characterized by Cmax of BAY80-6946 (and its metabolite(s), if needed)Cmax: maximum drug concentration in plasma after single dose administrationdate_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by Cmax/D of BAY80-6946 (and its metabolite(s), if needed)Cmax/D: Cmax divided by total dose in [mg]date_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by tmax of BAY80-6946 (and its metabolite(s), if needed)tmax: time to reach maximum drug concentration in plasma after single (first) dosedate_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by AUC(0-tlast) of BAY80-6946 (and its metabolite(s), if needed)AUC(0-tlast): AUC from time 0 to the last data point above lower limit of quantificationdate_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by AUC (if possible) of BAY80-6946 (and its metabolite(s), if needed)AUC: area under the plasma concentration vs time curve from zero to infinitydate_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by AUC/D of BAY80-6946 (and its metabolite(s), if needed)AUC/D: AUC divided by total dose in [mg]date_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by half-life of BAY80-6946 (and its metabolite(s), if needed)date_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by partial AUC values [eg, AUC(0-25)] of BAY80-6946 (and its metabolite(s), if needed)AUC(0-25): area under the plasma concentration vs time curve from zero to 25 h p.a.date_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by clearance of BAY80-6946 (and its metabolite(s), if needed)date_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by volume of distribution of BAY80-6946 (and its metabolite(s), if needed)date_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Estimation of percent of dose excreted [unchanged or as metabolites, if relevant) renally during 0 – 25 h after start of BAY80-6946 infusion (AE,ur(0-25)] (for Cohort 4 only)AE,ur(0-25): amount of drug excreted via urine during the collection interval 0 – 25 hdate_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by Cmax of Paclitaxel and 6-OH paclitaxeldate_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by tmax of Paclitaxel and 6-OH paclitaxeldate_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by AUC(0-t) of Paclitaxel and 6-OH paclitaxeldate_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by AUC of Paclitaxel and 6-OH paclitaxeldate_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by half-life of Paclitaxel and 6-OH paclitaxeldate_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by clearance of Paclitaxel and 6-OH paclitaxeldate_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Pharmacokinetics characterized by volume of distribution (If possible and needed) of Paclitaxel and 6-OH paclitaxeldate_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Effect of BAY80-6946 on paclitaxel PK will be assessed by comparing Cmax of Cycle 1 Day 1 and Cycle 1 Day 15date_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
- Effect of BAY80-6946 on paclitaxel PK will be assessed by comparing AUC(0-tlast) of Cycle 1 Day 1 and Cycle 1 Day 15date_rangeTime Frame:Multiple time points up to 6 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of patients with mutational statusdate_rangeTime Frame:Up to 3 years or longer if indicatedenhanced_encryptionNoSafety Issue:
- Tumor Response as measured by RECIST 1.1 criteriadate_rangeTime Frame:Up to 3 years or longer if indicatedenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1