Trial · NCT02510001
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | Determine maximum tolerated dose (MTD) of PD-0325901 with Crizotinib (PF-02341066) according to toxicities graded by NCI CTCAE v4.03, in patients with advanced solid tumours. |
| Primary | Clinical Response to Binimetinib Combined With PF-02341066 | Dose Expansion phase: change from baseline and up to 12 months. | To investigate response to treatment with RPII dose of Binimetinib with Crizotinib (PF-02341066), in patients with a) RASMT CRC or b) RASWT/cMET mut amplified CRC or c) RASWT/c-MET over-expressed CRC, as defined by stable, partially or completely responding disease, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase (\>=20%) to qualify for Progressive Disease; Overall Response (OR) = CR + PR + SD |
| Primary | Maximal Tolerated Dose (MTD) of Binimetinib and PF-02341066 | Dose Escalation Phase: treatment Cycle 1 28 days | To determine the maximal tolerated dose (MTD) of Binimetinib with PF-02341066 according to toxicities graded by NCI CTCAE V4.03 in cycle 1 of treatment. |
| 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 | To investigate the pharmacokinetics (PK) plasma Cmax of PD-0325901 (and its metabolite, PD-0315209) with PF-023241066 when administered in combination. |
| 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 | To investigate the pharmacokinetics (PK) plasma Cmin of PD-0325901 (and its metabolite, PD-0315209) with PF-023241066 when administered in combination. |
| 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 | To investigate the pharmacokinetics (PK) plasma AUC of PD-0325901 (and its metabolite, PD-0315209) with PF-023241066 when administered in combination. |
| 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 | To investigate the pharmacokinetics (PK) plasma oral clearance of PD-0325901 (and its metabolite, PD-0315209) with PF-023241066 when administered in combination. |
| 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)). | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a \>=20% increase in the sum of diameters of target lesions (also demonstrating an absolute increase of at least 5mm) or the appearance of new lesions. |
| 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). | Overall survival (dose expansion). |
| 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 | To investigate the pharmacokinetic (PK) peak plasma concentration (Cmax) of PF-02341066 and Binimetinib and its metabolite, AR00426032, in blood. |
| 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 . | To investigate pharmacokinetic plasma trough concentration Cmin of PF-02341066 and Binimetinib and its metabolite, AR00426032, in blood. |
| 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 | To investigate pharmacokinetic area under the plasma concentration versus time curve (AUC) of PF-02341066 and Binimetinib in blood. |
| 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 | To investigate pharmacokinetic (PK) oral clearance of PF-02341066 and Binimetinib in blood. |
| 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. | Measurement of phosphoMEK1/2 in skin biopsies to investigate the pharmacodynamic (PD) effect of PF-02341066 in combination with PD-0325901 or Binimetinib in paired skin biopsies to determine objective response to treatment. Western blots are used to measure levels of expression and images are taken of the gels. Image J is used to measure pixels. The minimum is 0 and there is no maximum. |
| 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. | Measurement of pSTAT3Y705 to investigate the pharmacodynamic (PD) effect of PF-02341066 in combination with PD-0325901 or Binimetinib in paired tumour biopsies to determine objective response to treatment. Western blots are used to measure levels of expression and images are taken of the gels. Image J is used to measure pixels. The minimum is 0 and there is no maximum. |
| 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. | Measurement of phosphoERK1/2 to investigate the pharmacodynamic (PD) effect of PF-02341066 in combination with Binimetinib in paired tumour biopsies (where possible) to determine objective response to treatment. Western blots are used to measure levels of expression and images are taken of the gels. Image J is used to measure pixels. The minimum is 0 and there is no maximum. |
| 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 | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a \>=20% increase in the sum of diameters of target lesions (also demonstrating an absolute increase of at least 5mm) or the appearance of new lesions. |
| 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 | Overall survival (Dose escalation Binimetinib/PF-02341066). |
| 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 | To investigate the pharmacokinetics (PK) plasma Cmax of Binimetinib (and its metabolite AR00426032) with PF-023241066 when administered in combination. |
| 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 | To investigate the pharmacokinetic (PK) minimum plasma trough concentration (Cmin) of PF-02341066 and binimetinib in blood. |
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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