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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00405587
Registration number
NCT00405587
Ethics application status
Date submitted
28/11/2006
Date registered
30/11/2006
Date last updated
22/08/2017
Titles & IDs
Public title
Safety Study of PLX4032 in Patients With Solid Tumors
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Scientific title
A Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX4032 in Patients With Solid Tumors
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Secondary ID [1]
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PLX06-02
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malignant Melanoma
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0
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Colorectal Carcinoma
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0
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Condition category
Condition code
Cancer
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Malignant melanoma
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Cancer
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0
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PLX4032
Experimental: PLX4032 - Open-label, sequential dose escalation
Treatment: Drugs: PLX4032
Oral capsules administered BID
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 1 - Dose Escalation: Original Formulation
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Assessment method [1]
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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.
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Timepoint [1]
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Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose
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Primary outcome [2]
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Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 on Day 15 - Dose Escalation: Original Formulation
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Assessment method [2]
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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.
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Timepoint [2]
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Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose
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Primary outcome [3]
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Peak Concentration (Cmax) of RO5185426 on Day 1 - Dose Escalation: Original Formulation
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Assessment method [3]
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Timepoint [3]
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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
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Primary outcome [4]
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Peak Concentration (Cmax) of RO5185426 on Day 15 - Dose Escalation: Original Formulation
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Assessment method [4]
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Timepoint [4]
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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
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Primary outcome [5]
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Time to Peak Concentration (Tmax) of RO5185426 on Day 1 - Dose Escalation: Original Formulation
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Assessment method [5]
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Timepoint [5]
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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
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Primary outcome [6]
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Time to Peak Concentration (Tmax) of RO5185426 on Day 15 - Dose Escalation: Original Formulation
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Assessment method [6]
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Timepoint [6]
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Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, pre-morning dose on Day 16
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Primary outcome [7]
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AUC of RO5185426 on Day 1 - Dose Escalation: MBP Formulation
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Assessment method [7]
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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.
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Timepoint [7]
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0
Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose
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Primary outcome [8]
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AUC of RO5185426 on Day 15 - Dose Escalation: MBP Formulation
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Assessment method [8]
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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.
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Timepoint [8]
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Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose
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Primary outcome [9]
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Mean RO5185426 Accumulation Ratios - Dose Escalation: MBP Formulation
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Assessment method [9]
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Accumulation ratio is the ratio of AUC (0-8 hour) on Day 15 / AUC (0-8 hour) on Day 1.
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Timepoint [9]
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Day 1 and Day 15: pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose
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Primary outcome [10]
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Mean RO5185426 Accumulation Ratios - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC
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Assessment method [10]
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Accumulation ratio is the ratio of AUC (0-8 hour) on Day 15 / AUC (0-8 hour) on Day 1.
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Timepoint [10]
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Day 1 and Day 15: pre-morning dose and at 0.5, 1, 2, 4, and 8 hours post-morning dose
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Primary outcome [11]
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Cmax of RO5185426 on Day 1 - Dose Escalation: MBP Formulation
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Assessment method [11]
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Timepoint [11]
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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
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Primary outcome [12]
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Cmax of RO5185426 on Day 15 - Dose Escalation: MBP Formulation
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Assessment method [12]
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0
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Timepoint [12]
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Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, and pre-morning dose on Day 16
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Primary outcome [13]
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Tmax of RO5185426 on Day 1 - Dose Escalation: MBP Formulation
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Assessment method [13]
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0
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Timepoint [13]
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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
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Primary outcome [14]
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0
Tmax of RO5185426 on Day 15 - Dose Escalation: MBP Formulation
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Assessment method [14]
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0
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Timepoint [14]
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Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, and pre-morning dose on Day 16
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Primary outcome [15]
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AUC of RO5185426 on Day 1 - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC
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Assessment method [15]
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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.
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Timepoint [15]
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0
Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose
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Primary outcome [16]
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AUC of RO5185426 on Day 15 - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC
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Assessment method [16]
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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.
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Timepoint [16]
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0
Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose
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Primary outcome [17]
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Cmax of RO5185426 on Day 1 - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC
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Assessment method [17]
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Timepoint [17]
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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
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Primary outcome [18]
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0
Cmax of RO5185426 on Day 15 - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- Positive CRC
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Assessment method [18]
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0
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Timepoint [18]
0
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Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15 and pre-morning dose on Day 16
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Primary outcome [19]
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0
Tmax of RO5185426 on Day 1 - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- CRC
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Assessment method [19]
0
0
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Timepoint [19]
0
0
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
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Primary outcome [20]
0
0
Tmax of RO5185426 on Day 15 - Extension: BRAFV600E- Positive Melanoma and BRAFV600E- CRC
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Assessment method [20]
0
0
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Timepoint [20]
0
0
Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 15, and pre-morning dose on Day 16
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Primary outcome [21]
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Percentage of Participants With a Confirmed and an Unconfirmed Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST Version (v) 1.0 - Extension: BRAFV600E- Positive Melanoma
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Assessment method [21]
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BOR of confirmed /unconfirmed (total) response was defined as CR or PR recorded from baseline until disease progression/recurrence according to Response Evaluation Criteria In Solid Tumors (RECIST) v 1.0 criteria. For target lesions (TLs), CR was defined as the disappearance of all TLs, and PR was defined as at least a 30 percent (%) decrease in the sum of longest diameters of the TLs, taking as a reference the baseline (BL) sum of longest diameters. For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Confirmed responses were those which were confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met. Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.
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Timepoint [21]
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0
Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)
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Primary outcome [22]
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Percentage of Participants With BOR of CR or PR According to RECIST v1.0 - Extension: BRAFV600E- Positive CRC
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Assessment method [22]
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BOR of CR or PR was recorded from baseline until disease progression/recurrence according to RECIST v 1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of longest diameters of the TLs, taking as a reference the BL sum of longest diameters. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Confirmed responses were those which were confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.
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Timepoint [22]
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0
Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)
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Primary outcome [23]
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Percentage of Participants With BOR of CR or PR According to RECIST v1.0 - Dose Escalation: Original Formulation
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Assessment method [23]
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BOR of CR or PR was recorded from baseline until disease progression/recurrence according to RECIST v 1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of longest diameters of the TLs, taking as a reference the BL sum of longest diameters. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.
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Timepoint [23]
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0
Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)
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Primary outcome [24]
0
0
Percentage of Participants With BOR of CR or PR According to RECIST v1.0 - Dose Escalation: MBP Formulation
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Assessment method [24]
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0
BOR of CR or PR was recorded from baseline until disease progression/recurrence according to RECIST v 1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of longest diameters of the TLs, taking as a reference the BL sum of longest diameters. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with best overall response rate was calculated as the (number of participants with CR or PR) divided by (total number of participants in the cohort), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.
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Timepoint [24]
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0
Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)
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Secondary outcome [1]
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Duration of CR or PR Using RECIST v 1.0 - Extension BRAFV600E- Positive Melanoma
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Assessment method [1]
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Duration of response for participants with confirmed CR or PR was the period of time measured between the date that the criteria for objective CR or PR (whichever status was recorded first) was met, and the first date that recurrent or PD was objectively documented (or death if before progression). PD was at least a 20% increase in the sum of longest diameters of TLs taking as reference the smallest sum of longest diameters recorded since the baseline measurements, or the appearance of one or more new lesion(s). In the event of no disease progression or documented death prior to study termination, analysis cutoff, or initiation of confounding anticancer therapy, duration of response was censored at the date of the last evaluable tumor assessment.
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Timepoint [1]
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0
Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 337 days)
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Secondary outcome [2]
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Percentage of Participants With Progression-Free Survival (PFS) Using RECIST v 1.0 - Melanoma Extension Cohort
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Assessment method [2]
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PFS was the period of time measured from the date of initiation of therapy to the date of the appearance of new metastatic lesions, objective tumor progression, or death if before progression. PD was defined according to the RECIST criteria (v 1.0) as increase by at least 20% in the sum of the longest diameters of each TL, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. For Non-TLs, PD was defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs.
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Timepoint [2]
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0
Month 1, 3, 4, 6, 9, and Last event (350) days
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Secondary outcome [3]
0
0
PFS Using RECIST v1.0 - Extension BRAFV600E Positive Melanoma
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Assessment method [3]
0
0
PFS was the period of time measured from the date of initiation of therapy to the date of the appearance of new metastatic lesions, objective tumor progression, or death if before progression. PD was at least a 20% increase in the sum of longest diameters of TLs taking as reference the smallest sum of longest diameters recorded since the baseline measurements, or the appearance of one or more new lesion(s). For Non-TLs, disease progression was defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs. In the event of no disease progression or documented death prior to study termination, analysis cutoff, or start of confounding anticancer therapy, PFS was censored at the date of the last evaluable tumor assessment.
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Timepoint [3]
0
0
Screening, BL, until PD, or end of efficacy follow-up, up to data cutoff (up to 421 days)
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Secondary outcome [4]
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0
Percentage of Participants Who Died - Extension: BRAFV600E- Positive Melanoma
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Assessment method [4]
0
0
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Timepoint [4]
0
0
Screening, BL, until PD, or end of efficacy follow-up, up to 444 days
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Secondary outcome [5]
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0
Overall Survival (OS) - Extension: BRAFV600E- Positive Melanoma
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Assessment method [5]
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0
OS was the period of time measured from the date of initiation of therapy to the date of the death. In the event of no death prior to study termination or analysis data cutoff, OS was censored at the last known date that the patient was alive as documented on the follow-up case report form. If this date was not available, then the last known alive date from the database was used.
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Timepoint [5]
0
0
Screening, BL, until PD, or end of efficacy follow-up, up to 444 days
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Secondary outcome [6]
0
0
Time to CR or PR Using RECIST v1.0 - Extension: BRAFV600E- Positive Melanoma
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Assessment method [6]
0
0
Time to CR or PR was defined as the interval between the date of the first treatment to the date of the first documentation of confirmed CR or PR whichever occurred first, and not the date of confirmation at the subsequent tumor assessment. Time to response = Date of first response - initial dose date + 1.
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Timepoint [6]
0
0
Screening, BL, and up to 168 days
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Secondary outcome [7]
0
0
Mean Dose-Normalized Steady-State AUC of RO5185426 80 mg and 120 mg Capsules - Dose Escalation: MBP Formulation and Extension: BRAFV600E- Positive Melanoma
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Assessment method [7]
0
0
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.
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Timepoint [7]
0
0
Pre-morning dose and at 0.5, 1, 2, 4, and 8, and 24 hours post-morning dose
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Secondary outcome [8]
0
0
Mean Dose-Normalized Steady-State Cmax of RO5185426 80 mg and 120 mg Capsules - Dose Escalation: MBP Formulation and Extension: BRAFV600E- Positive Melanoma
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Assessment method [8]
0
0
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Timepoint [8]
0
0
Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1 and 15, pre-morning dose on Day 2 and Day 8, and Day 16
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Secondary outcome [9]
0
0
Decrease in Tumor Uptake of 18F-fluorodeoxyglucose (FDG)
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Assessment method [9]
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0
Tumor uptake of FDG was assessed by means of positron-emission tomography (PET)
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Timepoint [9]
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0
BL and Day 15
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Secondary outcome [10]
0
0
Cmax of RO5185426 - Food Effect
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Assessment method [10]
0
0
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Timepoint [10]
0
0
Pre-morning dose, 0.5, 1, 2, 4, and 8 hour post-morning dose on Day 1 and 15, pre-morning dose on Day 2, Day 8, and Day 16
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Secondary outcome [11]
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0
Tumor Levels of Phosphorylated Extracellular Signal-Regulated Kinapse (ERK), Cyclin D1, and Ki-67
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Assessment method [11]
0
0
The immunohisto-chemical analyses of the expression of phosphorylated ERK, cyclin D1, and Ki-67 in tumor-biopsy specimens was performed using hematoxylin and eosin staining.
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Timepoint [11]
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BL and Day 15
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Eligibility
Key inclusion criteria
- Solid tumors confirmed histologically whose tumors are refractory to standard therapy,
or for whom standard or curative therapy does not exist
- Patients from whom paired melanoma biopsies are planned must have a V600E+ BRAF
mutation confirmed prior to the administration of PLX4032
- Previous chemotherapy, immunotherapy, or radiation therapy must have been completed at
least 2 weeks prior to starting PLX4032 therapy, and all associated toxicity must be
resolved prior to administration of PLX4032
- Patients in the Extension cohorts (melanoma or adenocarcinoma of the colon or rectum)
must have both a V600E+ BRAF mutation and measurable disease (by RECIST V 1.0
criteria) prior to the administration of PLX4032. All patients enrolled must provide
archival or fresh melanoma tumor biopsy for confirmation of V600E+ BRAF mutation
status by TaqMan assay
- ECOG performance status 0 or 1
- Life expectancy = 3 months
- Adequate hematologic, hepatic, and renal function
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Brain metastases that are progressing or have been documented to be stable for less
than 3 months, or for which systemic corticosteroids are required
- Investigational drug use within 28 days of the first dose of PLX4032
- Uncontrolled intercurrent illness
- Refractory nausea and vomiting, malabsorption, or significant bowel resection that
would preclude adequate absorption
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2016
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Sample size
Target
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Accrual to date
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Final
109
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
0
0
Peter MacCallum Cancer Centre - East Melbourne
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Recruitment hospital [2]
0
0
Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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0
3002 - East Melbourne
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Recruitment postcode(s) [2]
0
0
- Parkville
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
New York
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Pennsylvania
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Tennessee
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Plexxikon
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
0
0
Roche Pharma AG
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this FIH study is to assess the safety and pharmacokinetics of
PLX4032 in patients with solid tumors. The secondary objective is to assess the
pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant
melanoma who have the V600E BRAF oncogenic mutation.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00405587
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Henry Hsu, MD
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Address
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0
Plexxikon
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
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0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00405587
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