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Clinical Trials, and HPO
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There is one clinical trial.
This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.
Description: DLTs will be evaluated during the first cycle. The number of DLTs will be used to determine the maximum tolerated dose (MTD)
Measure: Number of participants with dose limiting toxicities (DLTs) Time: Baseline through day 28Description: Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy
Measure: Number of participants with treatment emergent adverse events (AEs) Time: Baseline through up to 2 years or until disease progressionDescription: Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Measure: Number of participants with laboratory abnormalities Time: Baseline through up to 2 years or until disease progressionDescription: Best Overall Response by RECIST 1.1
Measure: Objective Response Rate Time: Baseline through up to 2 years or until disease progressionDescription: Single dose PK will be calculated including Maximum Observed Plasma Concentration (Cmax).
Measure: Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax) Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24Description: Single dose PK will be calculated including Time to reach Maximum Observed Plasma Concentration (Tmax).
Measure: Pharmacokinetic Parameters: Time to reach Maximum Observed Plasma Concentration (Tmax) Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24Description: Single dose PK will be calculated including Area Under the Curve from time 0 to the last sampling time point within the dose interval (AUClast)
Measure: Pharmacokinetic Parameters: Area Under the Curve from time 0 to the last sampling time point within the dose interval (AUClast) Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24Description: Single dose PK will be calculated including, as data permit, terminal elimination half life (t1/2)
Measure: Pharmacokinetic Parameters: Terminal elimination half life (t1/2) Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24Description: Single dose PK will be calculated including, as data permit, Area Under the Curve from time 0 extrapolated to infinity (AUCinf)
Measure: Pharmacokinetic Parameters: AUC from time 0 extrapolated to infinity (AUCinf) Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24Description: Single dose PK will be calculated including, as data permit, apparent oral plasma clearance (CL/F)
Measure: Pharmacokinetic Parameters: Apparent oral plasma clearance (CL/F) Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24Description: Single dose PK will be calculated including, as data permit, apparent volume of distribution (Vz/F)
Measure: Pharmacokinetic Parameters: Apparent volume of distribution (Vz/F) Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24Description: Multiple dose PK will be calculated including Maximum Observed Steady State Plasma Concentration (Css,max).
Measure: Pharmacokinetic Parameters: Maximum Observed Steady State Plasma Concentration (Css,max) Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24Description: Multiple dose PK will be calculated including Time to reach Maximum Observed Steady State Plasma Concentration (Tss,max).
Measure: Pharmacokinetic Parameters: Time to reach Maximum Observed Steady State Plasma Concentration (Tss,max) Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24Description: Multiple dose PK will be calculated including Area Under the Curve within one dose interval (AUCss,t)
Measure: Pharmacokinetic Parameters: Area Under the Curve within one dose interval (AUCss,t) Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24Description: Multiple dose PK will be calculated including, as data permit, steady state apparent oral plasma clearance (CL/F)
Measure: Pharmacokinetic Parameters: Steady state apparent oral plasma clearance (CL/F) Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8. 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24Description: Multiple dose PK will be calculated including, as data permit, steady state apparent volume of distribution (Vss/F)
Measure: Pharmacokinetic Parameters: Steady state apparent volume of distribution (Vss/F) Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24Description: Multiple dose PK will be calculated including, as data permit, accumulation ratio (Rac)
Measure: Pharmacokinetic Parameters: Accumulation ratio (Rac) Time: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24Description: DOR as assessed using RECIST 1.1
Measure: Duration of response (DOR) Time: Baseline through up to 2 years or until disease progressionDescription: PFS as assessed using RECIST 1.1.
Measure: Progression free survival (PFS) Time: Baseline through up to 2 years or until disease progressionDescription: TTP as assessed using RECIST 1.1.
Measure: Time to progression (TTP) Time: Baseline through up to 2 years or until disease progressionDescription: Proportion of participants alive at 6 months, 1 year and 2 years.
Measure: Overall Survival (OS) Time: Baseline through up to 2 yearsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports