Trial · NCT02510001
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximal Tolerated Dose (MTD) of PD-0325901 and PF-02341066 /PF-02341066 or Binimetinib With PF-02341066 | Dose Escalation Phase: treatment Cycle 1 28 days (plus 7 day run-in for PD-0325901/PF-02341066 combination) | Evaluable patients are those patients who completed cycle 1 or withdrew early for experiencing a DLT. Four patients withdrew early from the study not for DLTs, consequently 21 patients remained for the dose escalation primary analysis. | Dose Limiting Toxicities (DLTs) | NUMBER |
| PRIMARY | Clinical Response to Binimetinib Combined With PF-02341066 | Dose Expansion phase: change from baseline and up to 12 months. | Evaluable patients for the primary outcome are those patients who complete a response assessment after cycle 1 of treatment, or who progress early on treatment. 30 of the 36 recruited patients had a response assessment after cycle 1 or progressed early on treatment, and hence these 30 patients are evaluable for the primary analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Maximal Tolerated Dose (MTD) of Binimetinib and PF-02341066 | Dose Escalation Phase: treatment Cycle 1 28 days | Evaluable patients are those patients who completed cycle 1 or who withdraw early for experiencing a DLT. Three patients withdrew early from the study not for DLTs, consequently 17 of the 20 recruited patients are evaluable for this analysis. | Dose Limiting Toxicities (DLTs) | NUMBER |
| SECONDARY | Pharmacokinetic Peak Plasma Concentration (Cmax) for PF-02341066 and PD-0325901. | Dose Escalation:Up to 12 months. PK profile at pre-dose and up to 10 hrs post dose on Day - 1, Day 21 and Day 28 of Cycle 1 | ng/ml | MEAN | |
| SECONDARY | Pharmacokinetic Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and PD-0325901 | Dose Escalation:Up to 12 mths. Cycle 1 PK profile up to 10 hrs post dose on Day -1, 21 and 28 | PK analysis performed on Cycle 1 Day -1 and Day 21 only for PD-0325901 and PD-0315209 and on Cycle 1 Day 21 and Day 28 only for PF-02341066 according to dosing schedule Day -7 to Day 21 for PD-0325901 and Day 1 to Day 28 for PF-02341066. | ng/ml | MEAN |
| SECONDARY | Pharmacokinetic Area Under the Plasma Concentration Versus Time Curve (AUC) for PF-02341066 and PD-0325901(and Its Metabolite) | Dose Escalation:Up to12 months. Cycle 1 PK profile up to 10 hrs on Day -1, 21 and 28 | PK analysis performed on Cycle 1 Day -1 and Day 21 only for PD-0325901 and PD-0315209 and on Cycle 1 Day 21 and Day 28 only for PF-02341066 according to dosing schedule Day -7 to Day 21 for PD-0325901 and Day 1 to Day 28 for PF-02341066. | ng*hr/mL | MEAN |
| SECONDARY | Pharmacokinetic Plasma Oral Clearance for PF-02341066 and PD-0325901 | Dose Escalation:Up to12 months.PK profile at Cycle 1 up to 10 hrs post dose on Days -1, 21 and 28 | Oral clearance could not be calculated, as pre-specified, as bioavailability and full Area Under the Curve (AUC) data, specifically 0 to ∞ (infinity), was not available. Even though AUC data is available on Days -1, 21 and 28 for 0-10 hours, residual drug at time of next twice daily dose administration meant oral clearance could not be determined for most patients. | ||
| SECONDARY | Progression Free Survival (Dose Expansion) | From date of study entry until the date of progression or date of death, assessed up to study completion, an average of 6 months (dose expansion)). | All 37 registered patients are included in this analysis. | months | MEDIAN |
| SECONDARY | Overall Survival (Dose Expansion) | From date of study entry until the date of death, assessed up to study completion, an average of 6 months (dose escalation). | All 37 registered patients are included in this analysis. | months | MEDIAN |
| SECONDARY | Pharmacokinetic (PK) Peak Plasma Concentration (Cmax) for PF-02341066 and Binimetinib. | Dose Expansion: PK profile up to 10 hrs at Cycle 1 Day 21 | Data not available for 2 patients in PF-02341066 outcome measure and 8 patients each in binimetinib and AR00426032 outcome measures | ng/ml | MEAN |
| SECONDARY | Pharmacokinetic Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and Binimetinib. | Dose Expansion: PK profile on Cycle 1 Day 21 up to 10 hrs . | No data available for 8 patients for binimetinib outcome and for 16 patients in AR00426032 outcome measure. | Cmin (ng/ml) | MEAN |
| SECONDARY | Pharmacokinetic Area Under the Plasma Concentration Versus Time Curve (AUC) for PF-02341066 and Binimetinib. | Dose Expansion: PK profile on Cycle 1 Day 21 up to 10 hrs | No data available for 2 patients in PF-02341066 outcome measure, 8 for binimetinib outcome measure and 13 for AR00426032 outcome measure | ng.h/ml (0-10h ) | MEAN |
| SECONDARY | Pharmacokinetic Oral Clearance for PF-02341066 and Binimetinib. | Dose Escalation: PK profile at up to 10 hrs post dose on Cycle 1 Day 21 | Oral clearance could not be calculated, as pre-specified, as bioavailability and full Area Under the Curve (AUC) data, specifically 0 to ∞ (infinity), was not available. Even though AUC data is available on Day 21 for 0-10 hours, residual drug at time of next twice daily dose administration meant oral clearance could not be determined for most patients. | ||
| SECONDARY | Pharmacodynamic (PD) Effect of PF-02341066 in Combination With PD-0325901 or Binimetinib in Paired Skin Biopsies - Measurement of phosphoMEK1/2. | Dose Escalation and Expansion: at baseline and Cycle1, D15. | For the Dose Escalation phases of the study the paired skin biopsies were collected and analysed for eligible patients (achieving end of Cycle 1) where available. Samples for Collection of paired skin biopsies were mandatory for first 10 patients registered to the expansion phase of the study only. An additional 3 samples were collected and analysed in the Expansion phase due to multiple screening performed over several participating sites. | ratio | MEAN |
| SECONDARY | Pharmacodynamic (PD) Effect of PF-02341066 in Combination With PD-0325901 or Binimetinib in Paired Tumour Biopsies (Where Possible). | Dose Escalation: Biopsies at baseline and Cycle1 D15 - both optional. | Biopsies optional for this phase and only consented to by 2 patients for the combination of PF-02341066 with Binimetinib. | ratio | MEAN |
| SECONDARY | Pharmacodynamic (PD) Effect of PF-02341066 in Combination With Binimetinib in Paired Tumour Biopsies (Where Possible). | Dose Expansion: Biopsies at baseline and Cycle1 D15. Optional metastic tumour biopsy within 28 days following radiological confirmation of disease progression. | Most patients in expansion phase did not have biopsy collection at Day 15 despite consenting to this procedure prior to commencement of the trial mainly for ethical reasons or inability to access suitable tumour biopsy site. | ratio | MEAN |
| SECONDARY | Progression Free Survival (Dose Escalation Binimetinib/PF-02341066). | From date of study entry until the date of progression or date of death, assessed up to study completion, an average of 6 months | All patients registered for this escalation phase are included in this Intention to Treat analysis, as the number of patients in each arm are separately too small for survival analysis, and it is only to preliminarily assess efficacy of the drug. The data is presented as pre-specified in the Statistical Analysis Plan Version 1.0\_09Jun2016. | months | MEDIAN |
| SECONDARY | Overall Survival (Dose Escalation Binimetinib/PF-02341066) | From date of study entry until the date of death, assessed up to study completion, an average of 6 months | All patients registered for this escalation phase are included in this Intention to Treat analysis, as the number of patients in each arm are separately too small for survival analysis, and it is only to preliminarily assess efficacy of the drug. The data is present as pre-specified in the Statistical Analysis Plan Version 1.0\_09June2016. | months | MEDIAN |
| SECONDARY | Pharmacokinetic Peak Plasma Concentration (Cmax) for PF-02341066 and Binimetinib. | Dose Escalation:Up to 12 months. PK profile at pre-dose and up to 10 hrs post dose on Day 21 of Cycle 1 | Dose Escalation phase using binimetinib with PF-02341066. Sample data not available in each outcome measure for 2 patients in Dose level 5 and 1 in Dose level 5 (interval dosing) . | ng/ml | MEAN |
| SECONDARY | Pharmacokinetic (PK) Minimum Plasma Trough Concentration (Cmin) for PF-02341066 and Binimetinib. | Dose Escalation phase :Up to 12 months. PK profile at pre-dose and up to 10 hrs post dose on Day 21 of Cycle 1 | No data available for 4 patients in dose level 5, for 2 patients in dose level 5 (interval dosing) and for 1 patient in dose level 5a | ng/ml | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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