Study Stopped
Slow accrual
Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002)
A Non-Randomized Phase Ib-II Protocol of Paclitaxel, Carboplatin and the Dual PI3K/mTOR Kinase Inhibitor, PF-05212384, for Patients With Advanced, or Metastatic Non-Small Cell Carcinoma of the Lung
4 other identifiers
interventional
3
1 country
1
Brief Summary
The purpose of this research study is to determine if the study drug, Gedatolisib (PF-05212384), given in combination with paclitaxel and carboplatin will work against unresectable non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 nonsmall-cell-lung-cancer
Started Sep 2017
Shorter than P25 for phase_1 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2016
CompletedFirst Posted
Study publicly available on registry
September 30, 2016
CompletedStudy Start
First participant enrolled
September 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2019
CompletedResults Posted
Study results publicly available
October 3, 2019
CompletedOctober 4, 2019
October 1, 2019
1.3 years
September 27, 2016
July 16, 2019
October 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dose Tolerability
To identify the maximum tolerated dose of PF-05212384 in combination with paclitaxel and carboplatin in subjects with NSCLC.
1 year
Objective Response Rate (ORR)
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.
1 year
Study Arms (4)
Treatment Arm (Phase 1b; Gedatolisib Dose Level 1[110 mg])
EXPERIMENTALTreatment Arm (Phase 1b; Gedatolisib Dose Level 2[150 mg])
EXPERIMENTALTreatment Arm (Phase 1b; Gedatolisib Dose Level 3[180 mg])
EXPERIMENTALTreatment Arm (Phase 2; MTD of Gedatolisib from Phase Ib)
EXPERIMENTALInterventions
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
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.
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.
Eligibility Criteria
You may qualify if:
- Signed Institutional Review Board (IRB)-approved informed consent prior to any study-related procedures
- Age of 18 years or older
- Advanced-stage unresectable NSCLC, as confirmed by pathological and/or radiological analysis (subjects will be classified as having advanced disease if they were not eligible for, or had disease progression after, surgical or locoregional therapies)
- Prior chemotherapy will be allowed for other invasive malignancies, provided therapy was completed at least five years before the start of protocol therapy, and participants have recovered from all toxicities of that prior therapy
- Participants may have received prior chemotherapy for NSCLC
- In the Phase II portion, subjects must have disease which lacks PTEN expression by immunohistochemistry, or has known prior activating PI3K or inactivating PTEN gene mutations (mutations will not be assayed for specifically)
- Eastern Cooperative Oncology Group (ECOG) performance status score \< 2
- Life expectancy ≥ 12 week
- Participants must have measureable disease by RECIST criteria
- Absolute neutrophil count \> 1500 mm3 (individuals with benign ethnic neutropenia may be enrolled if they have no evidence of infectious diathesis, or febrile neutropenia at the time of enrollment)
- Platelet count ≥ 100×109 L
- Hgb ≥ 8.5 g/dL (subjects may receive transfusions to achieve this, in the absence of overt bleeding)
- Total Bilirubin ≤ 2 mg/dL
- aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤ 3 times the upper limit of normal range
- Serum creatinine ≤1.5 times the upper limit of the normal range
- +4 more criteria
You may not qualify if:
- Uncontrolled cardiac disease, congestive heart failure, angina, arrhythmias or hypertension.
- Myocardial infarction or unstable angina within 2 months of treatment.
- Known human immunodeficiency virus (HIV) infection or chronic active Hepatitis B (subjects will not be screened for this).
- Active clinically serious infection \> CTCAE Grade 2.
- Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Serious non-healing wound, ulcer, or bone fracture.
- Evidence or history of bleeding diathesis or coagulopathy
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug
- Women or men of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 6 months after the last dose of study drug
- Women who are pregnant or breastfeeding.
- History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Pfizercollaborator
Study Sites (1)
UF Health Cancer Center
Gainesville, Florida, 32608, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Protocol Development Manager
- Organization
- University of Florida Heath Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Dennie Jones, MD
University of Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2016
First Posted
September 30, 2016
Study Start
September 25, 2017
Primary Completion
January 2, 2019
Study Completion
April 4, 2019
Last Updated
October 4, 2019
Results First Posted
October 3, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share