Trial · NCT00405587
Safety Study of PLX4032 in Patients With Solid Tumors
NCT00405587, Phase 1, Completed, Plexxikon; results first posted 2017-08-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study of PLX4032 in Patients With Solid Tumors. Trials, record NCT00405587. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00405587
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of PLX4032 in Patients With Solid Tumors
- NCT number
- NCT00405587
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 109 participants, actual
- Lead sponsor
- Plexxikon
- Conditions
- Malignant Melanoma, Colorectal Carcinoma
- Interventions
- PLX4032
- First posted
- 2006-11-30
- Last updated
- 2017-08-22
- Results first posted
- 2017-08-22
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 1 - Dose Escalation: Original Formulation | Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose | AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule. |
| Primary | Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 15 - Dose Escalation: Original Formulation | Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose | AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule. |
| Primary | Peak Concentration (Cmax) of RO5185426 on Day 1 - Dose Escalation: Original Formulation | Pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8 | |
| Primary | Peak Concentration (Cmax) of RO5185426 on Day 15 - Dose Escalation: Original Formulation | Pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose on Day 15, pre-morning dose on Day 16 | |
| Primary | Time to Peak Concentration (Tmax) of RO5185426 on Day 1 - Dose Escalation: Original Formulation | Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8 | |
| Primary | Time to Peak Concentration (Tmax) of RO5185426 on Day 15 - Dose Escalation: Original Formulation | Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, pre-morning dose on Day 16 | |
| Primary | AUC of RO5185426 on Day 1 - Dose Escalation: MBP Formulation | Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose | AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule. |
| Primary | AUC of RO5185426 on Day 15 - Dose Escalation: MBP Formulation | Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose | AUC (0-8 hour) was defined as the area under the plasma concentration-time curve from time equals zero (0) to 8 hours post-dose. AUC (0-24 hour) was defined as the area under the plasma concentration-time curve from time equals 0 to 24 hours post-dose. AUC (0-8 hour) and AUC (0-24 hour) were computed using the linear trapezoidal rule. |
| Primary | Mean RO5185426 Accumulation Ratios - Dose Escalation: MBP Formulation | Day 1 and Day 15: pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose | Accumulation ratio is the ratio of AUC (0-8 hour) on Day 15 / AUC (0-8 hour) on Day 1. |
| Primary | Mean RO5185426 Accumulation Ratios - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC | Day 1 and Day 15: pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose | Accumulation ratio is the ratio of AUC (0-8 hour) on Day 15 / AUC (0-8 hour) on Day 1. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 1 - Dose Escalation: Original Formulation | Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose | Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category. | ug*hr/mL | MEAN |
| PRIMARY | Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 15 - Dose Escalation: Original Formulation | Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose | PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category. | ug*hr/mL | MEAN |
| PRIMARY | Peak Concentration (Cmax) of RO5185426 on Day 1 - Dose Escalation: Original Formulation | Pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8 | PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome. | Micrograms per milliliter | MEAN |
| PRIMARY | Peak Concentration (Cmax) of RO5185426 on Day 15 - Dose Escalation: Original Formulation | Pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose on Day 15, pre-morning dose on Day 16 | PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome. | Micrograms per milliliter | MEAN |
| PRIMARY | Time to Peak Concentration (Tmax) of RO5185426 on Day 1 - Dose Escalation: Original Formulation | Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1, pre-morning dose on Day 2 and Day 8 | PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome. | hours | MEDIAN |
| PRIMARY | Time to Peak Concentration (Tmax) of RO5185426 on Day 15 - Dose Escalation: Original Formulation | Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, pre-morning dose on Day 16 | PK Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome. | hours | MEDIAN |
| PRIMARY | AUC of RO5185426 on Day 1 - Dose Escalation: MBP Formulation | Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose | Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category. | ug*hr/mL | MEAN |
| PRIMARY | AUC of RO5185426 on Day 15 - Dose Escalation: MBP Formulation | Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose | Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category. | mcg*hr/mL | MEAN |
| PRIMARY | Mean RO5185426 Accumulation Ratios - Dose Escalation: MBP Formulation | Day 1 and Day 15: pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose | Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category. | ratio | MEAN |
| PRIMARY | Mean RO5185426 Accumulation Ratios - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC | Day 1 and Day 15: pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose | Pharmacokinetic (PK) Population: Participants who received all RO5185426 doses without dose reduction up to and including Day 15 and provided at least PK assessments up to and including 8 to 10 hours after first dose on Day 15. Number of participants analyzed=participants evaluable for this outcome; n=participants evaluable for specified category. | ratio | MEAN |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group134
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 1 - Dose Escalation: Original Formulation | Dose Escalation: Original Formulation - 200 mg | AUC (0-8 hour) (n= 6, 4, 4, 4) | 2.02 | Standard Deviation 1.03 | ug*hr/mL |
| Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 1 - Dose Escalation: Original Formulation | Dose Escalation: Original Formulation - 400 mg | AUC (0-8 hour) (n= 6, 4, 4, 4) | 3.28 | Standard Deviation 1.66 | ug*hr/mL |
| Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 1 - Dose Escalation: Original Formulation | Dose Escalation: Original Formulation - 800 mg | AUC (0-8 hour) (n= 6, 4, 4, 4) | 4.47 | Standard Deviation 0.61 | ug*hr/mL |
| Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 1 - Dose Escalation: Original Formulation | Dose Escalation: Original Formulation - 1600 mg | AUC (0-8 hour) (n= 6, 4, 4, 4) | 4.23 | Standard Deviation 2.0 | ug*hr/mL |
| Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 1 - Dose Escalation: Original Formulation | Dose Escalation: Original Formulation - 200 mg | AUC (0-24 hour) (n= 6, 4, 4, 4) | 8.43 | Standard Deviation 4.84 | ug*hr/mL |
| Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 1 - Dose Escalation: Original Formulation | Dose Escalation: Original Formulation - 400 mg | AUC (0-24 hour) (n= 6, 4, 4, 4) | 14.86 | Standard Deviation 7.89 | ug*hr/mL |
| Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 1 - Dose Escalation: Original Formulation | Dose Escalation: Original Formulation - 800 mg | AUC (0-24 hour) (n= 6, 4, 4, 4) | 21.66 | Standard Deviation 10.59 | ug*hr/mL |
| Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 1 - Dose Escalation: Original Formulation | Dose Escalation: Original Formulation - 1600 mg | AUC (0-24 hour) (n= 6, 4, 4, 4) | 22.34 | Standard Deviation 10.59 | ug*hr/mL |
| Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 15 - Dose Escalation: Original Formulation | Dose Escalation Original Formulation - 200 mg | AUC (0-8 hour) (n=6, 3, 3, 4) | 9.37 | Standard Deviation 6.18 | ug*hr/mL |
| Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 15 - Dose Escalation: Original Formulation | Dose Escalation: Original Formulation - 400 mg | AUC (0-8 hour) (n=6, 3, 3, 4) | 30.90 | Standard Deviation 11.44 | ug*hr/mL |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Escalation: Original Formulation | 26 | |
| Overall Study | STARTED | Dose Escalation: MBP Formulation | 30 | |
| Overall Study | STARTED | Extension: BRAFV600E- Positive Melanoma | 32 | |
| Overall Study | STARTED | Extension: BRAFV600E- Positive CRC | 21 | |
| Overall Study | COMPLETED | Dose Escalation: Original Formulation | 0 | |
| Overall Study | COMPLETED | Dose Escalation: MBP Formulation | 2 | |
| Overall Study | COMPLETED | Extension: BRAFV600E- Positive Melanoma | 10 | |
| Overall Study | COMPLETED | Extension: BRAFV600E- Positive CRC | 1 | |
| Overall Study | NOT COMPLETED | Dose Escalation: Original Formulation | 26 | |
| Overall Study | NOT COMPLETED | Dose Escalation: MBP Formulation | 28 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4,212
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 | Fatigue | General disorders | Dose Escalation: MBP Formulation - 160 mg | 1 | 4 | |
| other | Fatigue | General disorders | Dose Escalation: MBP Formulation - 240 mg | 2 | 4 | |
| other | Fatigue | General disorders | Dose Escalation: MBP Formulation - 320 mg | 1 | 3 | |
| other | Fatigue | General disorders | Dose Escalation: MBP Formulation - 360 mg | 4 | 5 | |
| other | Fatigue | General disorders | Dose Escalation: MBP Formulation - 720 mg | 3 | 7 | |
| other | Fatigue | General disorders | Dose Escalation: MBP Formulation - 1120 mg | 4 | 6 | |
| other | Fatigue | General disorders | Dose Escalation: Original Formulation - 200 mg | 2 | 6 | |
| other | Fatigue | General disorders | Dose Escalation: Original Formulation - 400 mg | 3 | 6 | |
| other | Fatigue | General disorders | Dose Escalation: Original Formulation - 800 mg | 6 | 10 | |
| other | Fatigue | General disorders | Dose Escalation: Original Formulation - 1600 mg | 0 | 4 |
1 to 10 of 4,212Source ClinicalTrials.gov
See all 4,212 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation: MBP Formulation - 160 mg | ||
| Total, all-cause mortality | Dose Escalation: MBP Formulation - 240 mg | ||
| Total, all-cause mortality | Dose Escalation: MBP Formulation - 320 mg | ||
| Total, all-cause mortality | Dose Escalation: MBP Formulation - 360 mg | ||
| Total, all-cause mortality | Dose Escalation: MBP Formulation - 720 mg | ||
| Total, all-cause mortality | Dose Escalation: MBP Formulation - 1120 mg | ||
| Total, all-cause mortality | Dose Escalation: Original Formulation - 200 mg | ||
| Total, all-cause mortality | Dose Escalation: Original Formulation - 400 mg | ||
| Total, all-cause mortality | Dose Escalation: Original Formulation - 800 mg | ||
| Total, all-cause mortality | Dose Escalation: Original Formulation - 1600 mg |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
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.
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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/NCT00405587
GET https://conductscience.org/api/trials/v1/NCT00405587/registered?page=2