Trial Outcomes & Findings for Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002) (NCT NCT02920450)
NCT ID: NCT02920450
Last Updated: 2019-10-04
Results Overview
To identify the maximum tolerated dose of PF-05212384 in combination with paclitaxel and carboplatin in subjects with NSCLC.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
1 year
Results posted on
2019-10-04
Participant Flow
Recruitment period was from 9/25/2017 until 12/06/2018, at which point the study was closed due to low accrual.
Participant milestones
| Measure |
Treatment Arm (Phase 1b; Dose Level 1)
Gedatolisib (Dose level 1\[110 mg\]), Paclitaxel, and Carboplatin
Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.
Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design.
|
Treatment Arm (Phase 1b; Dose Level 2)
Gedatolisib (Dose level 2\[150 mg\]), Paclitaxel, and Carboplatin
Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.
Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design.
|
Treatment Arm (Phase 1b; Dose Level 3)
Gedatolisib (Dose level 2\[180 mg\]), Paclitaxel, and Carboplatin
Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.
Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design.
|
Treatment Arm (Phase 2)
Gedatolisib (MTD From the Phase 1b portion), Paclitaxel, and Carboplatin
Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.
Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Arm (Phase 1b; Dose Level 1)
Gedatolisib (Dose level 1\[110 mg\]), Paclitaxel, and Carboplatin
Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.
Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design.
|
Treatment Arm (Phase 1b; Dose Level 2)
Gedatolisib (Dose level 2\[150 mg\]), Paclitaxel, and Carboplatin
Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.
Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design.
|
Treatment Arm (Phase 1b; Dose Level 3)
Gedatolisib (Dose level 2\[180 mg\]), Paclitaxel, and Carboplatin
Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.
Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design.
|
Treatment Arm (Phase 2)
Gedatolisib (MTD From the Phase 1b portion), Paclitaxel, and Carboplatin
Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.
Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design.
|
|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002)
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=3 Participants
Gedatolisib, Paclitaxel, and Carboplatin
Gedatolisib: During the first phase, subjects will be sequentially enrolled to each increasing dose level, beginning with dose level 1 (110 mg) until the first dose limiting toxicity occurs, or safely accrued to dose level 3. PF-05212384 is intravenously infused over a thirty minute period.
Dose Level 1: 110 mg Dose Level 2: 150 mg Dose Level 3: 180 mg
Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.
Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Data are not reported for this outcome measure because an insufficient number of participants were evaluable to determine the MTD.
To identify the maximum tolerated dose of PF-05212384 in combination with paclitaxel and carboplatin in subjects with NSCLC.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 yearPopulation: The sample of only 1 evaluable subject was not sufficient to analyze this outcome measure.
To estimate the objective rate of response of PF-05212384 in combination with paclitaxel and carboplatin administered to subjects with unresectable or metastatic NSCLC, according to current RECIST criteria. ORR is defined as the number of participants who achieved either a partial or complete response by RECIST 1.1 criteria. By these criteria, Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) is defined as a decrease of at least 30% in the sum of the longest diameter of the target lesions.
Outcome measures
Outcome data not reported
Adverse Events
Treatment Arm (Phase 1b; Gedatolisib Dose Level 1[110 mg])
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Treatment Arm (Phase 1b; Gedatolisib Dose Level 2[150 mg])
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Arm (Phase 1b; Gedatolisib Dose Level 3[180 mg])
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Arm (Phase 2; MTD of Gedatolisib From Phase Ib)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Arm (Phase 1b; Gedatolisib Dose Level 1[110 mg])
n=3 participants at risk
Gedatolisib, Paclitaxel, and Carboplatin
Gedatolisib: During the first phase, subjects will be sequentially enrolled to each increasing dose level, beginning with dose level 1 (110 mg) until the first dose limiting toxicity occurs, or safely accrued to dose level 3. PF-05212384 is intravenously infused over a thirty minute period.The dose given in the phase 2 portion will be the MTD determined in the phase Ib portion of the study.
Dose Level 1: 110 mg Dose Level 2: 150 mg Dose Level 3: 180 mg
Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.
Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design.
|
Treatment Arm (Phase 1b; Gedatolisib Dose Level 2[150 mg])
Gedatolisib, Paclitaxel, and Carboplatin
Gedatolisib: During the first phase, subjects will be sequentially enrolled to each increasing dose level, beginning with dose level 1 (110 mg) until the first dose limiting toxicity occurs, or safely accrued to dose level 3. PF-05212384 is intravenously infused over a thirty minute period.The dose given in the phase 2 portion will be the MTD determined in the phase Ib portion of the study.
Dose Level 1: 110 mg Dose Level 2: 150 mg Dose Level 3: 180 mg
Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.
Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design.
|
Treatment Arm (Phase 1b; Gedatolisib Dose Level 3[180 mg])
Gedatolisib, Paclitaxel, and Carboplatin
Gedatolisib: During the first phase, subjects will be sequentially enrolled to each increasing dose level, beginning with dose level 1 (110 mg) until the first dose limiting toxicity occurs, or safely accrued to dose level 3. PF-05212384 is intravenously infused over a thirty minute period.The dose given in the phase 2 portion will be the MTD determined in the phase Ib portion of the study.
Dose Level 1: 110 mg Dose Level 2: 150 mg Dose Level 3: 180 mg
Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.
Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design.
|
Treatment Arm (Phase 2; MTD of Gedatolisib From Phase Ib)
Gedatolisib, Paclitaxel, and Carboplatin
Gedatolisib: During the first phase, subjects will be sequentially enrolled to each increasing dose level, beginning with dose level 1 (110 mg) until the first dose limiting toxicity occurs, or safely accrued to dose level 3. PF-05212384 is intravenously infused over a thirty minute period.The dose given in the phase 2 portion will be the MTD determined in the phase Ib portion of the study.
Dose Level 1: 110 mg Dose Level 2: 150 mg Dose Level 3: 180 mg
Paclitaxel: Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.
Carboplatin: The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design.
|
|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from the time a subject signed consent until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the 2 subjects for whom adverse event data was collected was 2.6 and 5.75 months.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time a subject signed consent until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
—
0/0 • Adverse event data was collected from the time a subject signed consent until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the 2 subjects for whom adverse event data was collected was 2.6 and 5.75 months.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time a subject signed consent until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
—
0/0 • Adverse event data was collected from the time a subject signed consent until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the 2 subjects for whom adverse event data was collected was 2.6 and 5.75 months.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time a subject signed consent until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
—
0/0 • Adverse event data was collected from the time a subject signed consent until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the 2 subjects for whom adverse event data was collected was 2.6 and 5.75 months.
Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time a subject signed consent until 28 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
|
Other adverse events
Adverse event data not reported
Additional Information
Protocol Development Manager
University of Florida Heath Cancer Center
Phone: 352-273-8128
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place