Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002)
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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
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Study Type | Interventional |
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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) |
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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 | |
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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. |
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Overall Number of Baseline Participants | 3 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
1 33.3%
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>=65 years |
2 66.7%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | |
Female |
2 66.7%
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Male |
1 33.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | |
Hispanic or Latino |
0 0.0%
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Not Hispanic or Latino |
3 100.0%
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Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
3 100.0%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 3 participants |
3 |
Name/Title: | Protocol Development Manager |
Organization: | University of Florida Heath Cancer Center |
Phone: | 352-273-8128 |
EMail: | clh1230@ufl.edu |
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 |