Trial · NCT02510001
MEK and MET Inhibition in Colorectal Cancer
NCT02510001, Phase 1, Completed, University of Oxford; results first posted 2021-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MEK and MET Inhibition in Colorectal Cancer. Trials, record NCT02510001. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02510001
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MEK and MET Inhibition in Colorectal Cancer
- NCT number
- NCT02510001
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 82 participants, actual
- Lead sponsor
- University of Oxford
- Conditions
- Solid Tumor, Colorectal Cancer
- Interventions
- PF-02341066, PD-0325901, Binimetinib
- First posted
- 2015-07-28
- Last updated
- 2021-07-13
- Results first posted
- 2021-04-26
- Limitations and caveats
- Few patients stayed on treatment beyond cycle 2 so long term tolerability has not been evaluated in depth.
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group173
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximal Tolerated Dose (MTD) of PD-0325901 and PF-02341066 /PF-02341066 or Binimetinib With PF-02341066 | Dose Escalation Phase Cohort 1 Dose Level 1 | 0 | Dose Limiting Toxicities (DLTs) | ||
| Maximal Tolerated Dose (MTD) of PD-0325901 and PF-02341066 /PF-02341066 or Binimetinib With PF-02341066 | Dose Escalation Phase Cohort 2 Dose Level 2 | 0 | Dose Limiting Toxicities (DLTs) | ||
| Maximal Tolerated Dose (MTD) of PD-0325901 and PF-02341066 /PF-02341066 or Binimetinib With PF-02341066 | Dose Escalation Phase Cohort 3 Dose Level 3 | 0 | Dose Limiting Toxicities (DLTs) | ||
| Maximal Tolerated Dose (MTD) of PD-0325901 and PF-02341066 /PF-02341066 or Binimetinib With PF-02341066 | Dose Escalation Phase Cohort 4 Dose Level 4 | 1 | Dose Limiting Toxicities (DLTs) | ||
| Clinical Response to Binimetinib Combined With PF-02341066 | Dose Expansion Phase | Stable Disease | 7 | Participants | |
| Clinical Response to Binimetinib Combined With PF-02341066 | Dose Expansion Phase | Progressive Disease | 22 | Participants | |
| Clinical Response to Binimetinib Combined With PF-02341066 | Dose Expansion Phase | Early death from malignant disease | 1 | Participants | |
| Maximal Tolerated Dose (MTD) of Binimetinib and PF-02341066 | Dose Escalation Phase Cohort 7 Dose Level 5 | 2 | Dose Limiting Toxicities (DLTs) | ||
| Maximal Tolerated Dose (MTD) of Binimetinib and PF-02341066 | Dose Escalation Phase Cohort 12 Dose Level 5 (Interval Dosing) | 2 | Dose Limiting Toxicities (DLTs) | ||
| Maximal Tolerated Dose (MTD) of Binimetinib and PF-02341066 | Dose Escalation Phase Cohort 13 Dose Level 5a | 1 | Dose Limiting Toxicities (DLTs) |
1 to 10 of 173Source ClinicalTrials.gov
See all 173 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Escalation Phase Dose 1. | 6 | |
| Overall Study | STARTED | Dose Escalation Phase Dose 2. | 5 | |
| Overall Study | STARTED | Dose Escalation Phase Dose 3. | 6 | |
| Overall Study | STARTED | Dose Escalation Phase Dose 4. | 8 | |
| Overall Study | STARTED | Dose Escalation Phase 5. | 8 | |
| Overall Study | STARTED | Dose Escalation Phase Dose 5a | 7 | |
| Overall Study | STARTED | Dose Escalation Phase Dose 5 (Interval Dosing) | 5 | |
| Overall Study | STARTED | Dose Expansion Phase | 37 | |
| Overall Study | COMPLETED | Dose Escalation Phase Dose 1. | 6 | |
| Overall Study | COMPLETED | Dose Escalation Phase Dose 2. | 5 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events873
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal abscess | Infections and infestations | Dose Escalation Phase 1 PF-02341066 and PD-0325901 | 1 | 25 | 1 |
| other | Abdominal abscess | Infections and infestations | Dose Escalation Phase 2 PF-0341066 and Binimetinib | 0 | 20 | 0 |
| other | Abdominal abscess | Infections and infestations | Dose Expansion Phase | 0 | 36 | 0 |
| other | Abdominal Distension | Gastrointestinal disorders | Dose Escalation Phase 1 PF-02341066 and PD-0325901 | 0 | 25 | 0 |
| other | Abdominal Distension | Gastrointestinal disorders | Dose Escalation Phase 2 PF-0341066 and Binimetinib | 0 | 20 | 0 |
| other | Abdominal Distension | Gastrointestinal disorders | Dose Expansion Phase | 1 | 36 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Dose Escalation Phase 1 PF-02341066 and PD-0325901 | 3 | 25 | 3 |
| other | Abdominal Pain | Gastrointestinal disorders | Dose Escalation Phase 2 PF-0341066 and Binimetinib | 1 | 20 | 3 |
| other | Abdominal Pain | Gastrointestinal disorders | Dose Expansion Phase | 5 | 36 | 7 |
| other | Abdominal Pain Lower | Gastrointestinal disorders | Dose Escalation Phase 1 PF-02341066 and PD-0325901 | 0 | 25 | 0 |
1 to 10 of 873Source ClinicalTrials.gov
See all 873 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation Phase 1 PF-02341066 and PD-0325901 | 18 | 25 |
| Total, all-cause mortality | Dose Escalation Phase 2 PF-0341066 and Binimetinib | 15 | 20 |
| Total, all-cause mortality | Dose Expansion Phase | 27 | 36 |
| Total, other adverse events | Dose Escalation Phase 1 PF-02341066 and PD-0325901 | 25 | 25 |
| Total, other adverse events | Dose Escalation Phase 2 PF-0341066 and Binimetinib | 20 | 20 |
| Total, other adverse events | Dose Expansion Phase | 36 | 36 |
| Total, serious adverse events | Dose Escalation Phase 1 PF-02341066 and PD-0325901 | 9 | 25 |
| Total, serious adverse events | Dose Escalation Phase 2 PF-0341066 and Binimetinib | 12 | 20 |
| Total, serious adverse events | Dose Expansion Phase | 18 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02510001
GET https://conductscience.org/api/trials/v1/NCT02510001/registered?page=2