Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02920450
Recruitment Status : Terminated (Slow accrual)
First Posted : September 30, 2016
Results First Posted : October 3, 2019
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: Gedatolisib
Drug: Paclitaxel
Drug: Carboplatin
Enrollment 3
Recruitment Details Recruitment period was from 9/25/2017 until 12/06/2018, at which point the study was closed due to low accrual.
Pre-assignment Details  
Arm/Group Title Treatment Arm (Phase 1b; Dose Level 1) Treatment Arm (Phase 1b; Dose Level 2) Treatment Arm (Phase 1b; Dose Level 3) Treatment Arm (Phase 2)
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 3 0 0 0
Completed 1 0 0 0
Not Completed 2 0 0 0
Reason Not Completed
Death             1             0             0             0
Withdrawal by Subject             1             0             0             0
Arm/Group Title Treatment Arm
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  33.3%
>=65 years
2
  66.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
3
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Dose Tolerability
Hide Description To identify the maximum tolerated dose of PF-05212384 in combination with paclitaxel and carboplatin in subjects with NSCLC.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not reported for this outcome measure because an insufficient number of participants were evaluable to determine the MTD.
Arm/Group Title Treatment Arm
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The sample of only 1 evaluable subject was not sufficient to analyze this outcome measure.
Arm/Group Title Treatment Arm
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 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 Event Reporting Description 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.
 
Arm/Group Title Treatment Arm (Phase 1b; Gedatolisib Dose Level 1[110 mg]) Treatment Arm (Phase 1b; Gedatolisib Dose Level 2[150 mg]) Treatment Arm (Phase 1b; Gedatolisib Dose Level 3[180 mg]) Treatment Arm (Phase 2; MTD of Gedatolisib From Phase Ib)
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Treatment Arm (Phase 1b; Gedatolisib Dose Level 1[110 mg]) Treatment Arm (Phase 1b; Gedatolisib Dose Level 2[150 mg]) Treatment Arm (Phase 1b; Gedatolisib Dose Level 3[180 mg]) Treatment Arm (Phase 2; MTD of Gedatolisib From Phase Ib)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/3 (33.33%)      0/0      0/0      0/0    
Hide Serious Adverse Events
Treatment Arm (Phase 1b; Gedatolisib Dose Level 1[110 mg]) Treatment Arm (Phase 1b; Gedatolisib Dose Level 2[150 mg]) Treatment Arm (Phase 1b; Gedatolisib Dose Level 3[180 mg]) Treatment Arm (Phase 2; MTD of Gedatolisib From Phase Ib)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      0/0      0/0      0/0    
Infections and infestations         
Sepsis  1 [1]  1/3 (33.33%)  1 /0  /0  /0 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Grade 4 Sepsis
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Arm (Phase 1b; Gedatolisib Dose Level 1[110 mg]) Treatment Arm (Phase 1b; Gedatolisib Dose Level 2[150 mg]) Treatment Arm (Phase 1b; Gedatolisib Dose Level 3[180 mg]) Treatment Arm (Phase 2; MTD of Gedatolisib From Phase Ib)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/0      0/0      0/0    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Protocol Development Manager
Organization: University of Florida Heath Cancer Center
Phone: 352-273-8128
EMail: clh1230@ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02920450    
Other Study ID Numbers: IRB201601181 -A
WI211924 ( Other Identifier: Pfizer Inc. )
UF-STO-LUNG-002 ( Other Identifier: University of Florida )
OCR15075 ( Other Identifier: University of Florida )
First Submitted: September 27, 2016
First Posted: September 30, 2016
Results First Submitted: July 16, 2019
Results First Posted: October 3, 2019
Last Update Posted: October 4, 2019