Trial · NCT01004861
Safety Study of PLX108-01 in Patients With Solid Tumors
NCT01004861, Phase 1, Completed, Daiichi Sankyo; results first posted 2020-04-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study of PLX108-01 in Patients With Solid Tumors. Trials, record NCT01004861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01004861
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of PLX108-01 in Patients With Solid Tumors
- NCT number
- NCT01004861
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 132 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Solid Tumor
- Interventions
- PLX3397
- First posted
- 2009-10-30
- Last updated
- 2022-01-04
- Results first posted
- 2020-04-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population) | Every 2 months beginning Cycle 3, Day 1 until disease progression (up to approximately 30 months postdose) | Best overall tumor response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) is reported, including participants who were not evaluable (NE). RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Primary | Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Extension (Efficacy Evaluable Population) | Every 2 months beginning Cycle 3, Day 1 until disease progression (up to approximately 30 months postdose) | Best overall tumor response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) is reported, including participants who were not evaluable (NE). RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Primary | Duration of Response (Efficacy Evaluable Population) - Dose Extension | From initial response until disease progression or death, up to approximately 30 months postdose | Duration of Response (DOR) is defined as the number of days from the date of initial response (CR or PR confirmed at least 28 days later) to the date of first documented disease progression/relapse or death, whichever occurs first. If no disease progression or death is documented prior to study termination, analysis cutoff, or the start of confounding anticancer therapy, DOR is censored as of the date of their last imaging exam of target or non-target lesions prior to post-surgery and/or off-treatment scans. |
| Primary | Progression-free Survival (Efficacy Evaluable Population) - Dose Extension | From Cycle 1 Day 1 to disease progression or death | Progression-Free Survival (PFS) is defined as the number of days from the first day of treatment to the first documented disease progression or date of death, whichever occurs first. If no disease progression or death is documented prior to study termination, analysis cutoff, or the start of confounding anticancer therapy, PFS is censored at the date of last evaluable tumor assessment. |
| Primary | Best Overall Tumor Response (PVNS Cohort) Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Extension | Every 2 months beginning Cycle 3, Day 1 until disease progression | Best overall tumor response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) is reported, including participants who were not evaluable (NE). RECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Primary | Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Cmax, Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation | Cycle 1, Day 15 | Cycle 1 Day 15 pharmacokinetic (PK) timepoints taken are: For once daily (QD) dosing, obtained predose (morning) and 0.5, 1, 2, 4, and 8 hours postdose. For twice a day (BID) dosing predose (morning) and 1, 2, 4, and 7 hours postdose. The second dose will then be administered, and PK obtained 1 hour post the second dose (8 hours post the first dose). For BID dosing, no run-in is planned. |
| Primary | Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Tmax, Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation | Cycle 1, Day 15 | Cycle 1 Day 15 PK timepoints taken are: For QD dosing, obtained predose (morning) and 0.5, 1, 2, 4, and 8 hours postdose. For BID dosing predose (morning) and 1, 2, 4, and 7 hours postdose. The second dose will then be administered, and PK obtained 1 hour post the second dose (8 hours post the first dose). For BID dosing, no run-in is planned. |
| Primary | Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Area Under the Curve (AUC0-24), Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation | Cycle 1, Day 15 (QD dosing: predose [morning] and 0.5, 1, 2, 4, and 8 hours postdose; BID dosing: predose [morning] and 1, 2, 4, and 7 hours postdose) | Cycle 1 Day 15 PK timepoints taken are: For QD dosing, obtained predose (morning) and 0.5, 1, 2, 4, and 8 hours postdose. For BID dosing, predose (morning) and 1, 2, 4, and 7 hours postdose. The second dose will then be administered, and PK obtained 1 hour post the second dose (8 hours post the first dose). For BID dosing, no run-in is planned. |
| Primary | Numeric Rating Scale (NRS) for PVNS Symptoms Sum of Scores Through Cycle 2 (Efficacy Evaluable Population) - Dose Extension | Baseline, Cycle 1 Day 15, Cycle 2, Cycle 3, Cycle 12, Cycle 24, Cycle 36, and Cycle 46 (each cycle was 28 days) | The NRS for PVNS Symptoms instrument is a 5-item self-administered questionnaire to assess the "worst" of each of the symptoms pain, swelling, stiffness, instability and limited motion in the last 24 hours. A 0 to 10 NRS is provided for each symptom. For pain, 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine". For the other 4 symptoms, 0 indicates "no (symptom)" and 10 indicates "(symptom) worst imaginable", e.g., "swelling - worst imaginable." Higher scores indicated worse outcome. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population) | Every 2 months beginning Cycle 3, Day 1 until disease progression (up to approximately 30 months postdose) | Best overall tumor response was assessed in the Efficacy Evaluable Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Extension (Efficacy Evaluable Population) | Every 2 months beginning Cycle 3, Day 1 until disease progression (up to approximately 30 months postdose) | Best overall tumor response was assessed in the Efficacy Evaluable Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Duration of Response (Efficacy Evaluable Population) - Dose Extension | From initial response until disease progression or death, up to approximately 30 months postdose | Duration of response was assessed among participants with response of CR or PR in the Efficacy Evaluable Population. | days | MEDIAN |
| PRIMARY | Progression-free Survival (Efficacy Evaluable Population) - Dose Extension | From Cycle 1 Day 1 to disease progression or death | Progression-free survival was assessed in the Efficacy Evaluable Population. | days | MEDIAN |
| PRIMARY | Best Overall Tumor Response (PVNS Cohort) Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Extension | Every 2 months beginning Cycle 3, Day 1 until disease progression | Best overall tumor response was assessed in the Efficacy Evaluable Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Cmax, Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation | Cycle 1, Day 15 | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ng/mL | MEDIAN |
| PRIMARY | Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Tmax, Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation | Cycle 1, Day 15 | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | hour | MEDIAN |
| PRIMARY | Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Area Under the Curve (AUC0-24), Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation | Cycle 1, Day 15 (QD dosing: predose [morning] and 0.5, 1, 2, 4, and 8 hours postdose; BID dosing: predose [morning] and 1, 2, 4, and 7 hours postdose) | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ng*hr/mL | MEDIAN |
| PRIMARY | Numeric Rating Scale (NRS) for PVNS Symptoms Sum of Scores Through Cycle 2 (Efficacy Evaluable Population) - Dose Extension | Baseline, Cycle 1 Day 15, Cycle 2, Cycle 3, Cycle 12, Cycle 24, Cycle 36, and Cycle 46 (each cycle was 28 days) | NRS for PVNS symptoms were assessed in patients with available data in the Efficacy Evaluable Population. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group159
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population) | Dose Escalation Cohort 1: 200 mg QD | Censored participants | 0 | Participants | |
| Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population) | Dose Escalation Cohort 2: 300 mg QD | Censored participants | 1 | Participants | |
| Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population) | Dose Escalation Cohort 3: 400 mg QD | Censored participants | 2 | Participants | |
| Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population) | Dose Escalation Cohort 4: 600 mg QD | Censored participants | 0 | Participants | |
| Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population) | Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM) | Censored participants | 3 | Participants | |
| Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population) | Dose Escalation Cohort 6: 1200 mg/Day (600mg BID) | Censored participants | 0 | Participants | |
| Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population) | Dose Escalation Cohort 7: 1000 mg/Day (500mg BID) | Censored participants | 3 | Participants | |
| Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population) | All Participants | Censored participants | 9 | Participants | |
| Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population) | Dose Escalation Cohort 1: 200 mg QD | CR | 0 | Participants | |
| Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population) | Dose Escalation Cohort 2: 300 mg QD | CR | 0 | Participants |
1 to 10 of 159Source ClinicalTrials.gov
See all 159 results by groupParticipant flow39
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Escalation Cohort 1: 200 mg QD | 3 | |
| Overall Study | STARTED | Dose Escalation Cohort 2: 300 mg QD | 6 | |
| Overall Study | STARTED | Dose Escalation Cohort 3: 400 mg QD | 6 | |
| Overall Study | STARTED | Dose Escalation Cohort 4: 600 mg QD | 6 | |
| Overall Study | STARTED | Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM) | 7 | |
| Overall Study | STARTED | Dose Escalation Cohort 6: 1200 mg/Day (600mg BID) | 6 | |
| Overall Study | STARTED | Dose Escalation Cohort 7: 1000 mg/Day (500mg BID) | 7 | |
| Overall Study | STARTED | Dose Extension: MEC Cohort 1000 mg/Day (600mg AM, 400mg PM) | 4 | |
| Overall Study | STARTED | Dose Extension: PVNS Cohort PVNS Cohort 1000 mg/Day (600mg AM, 400mg PM) | 39 | |
| Overall Study | STARTED | Dose Extension: GIST Cohort 1000 mg/Day (600mg AM, 400mg PM) | 11 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 participant flowAdverse events4,069
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 Cohort 1: 200 mg QD | 0 | 3 | |
| other | Fatigue | General disorders | Dose Escalation Cohort 2: 300 mg QD | 3 | 6 | |
| other | Fatigue | General disorders | Dose Escalation Cohort 3: 400 mg QD | 1 | 6 | |
| other | Fatigue | General disorders | Dose Escalation Cohort 4: 600 mg QD | 3 | 6 | |
| other | Fatigue | General disorders | Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM) | 5 | 7 | |
| other | Fatigue | General disorders | Dose Escalation Cohort 6: 1200 mg/Day (600mg BID) | 2 | 6 | |
| other | Fatigue | General disorders | Dose Escalation Cohort 7: 1000 mg/Day (500mg BID) | 3 | 7 | |
| other | Fatigue | General disorders | MEC Cohort 1000 mg/Day (600mg AM, 400mg PM) | 2 | 4 | |
| other | Fatigue | General disorders | PVNS Cohort 1000 mg/Day (600mg AM, 400mg PM) | 36 | 39 | |
| other | Fatigue | General disorders | GIST Cohort 1000 mg/Day (600mg AM, 400mg PM) | 7 | 11 |
1 to 10 of 4,069Source ClinicalTrials.gov
See all 4,069 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation Cohort 1: 200 mg QD | 0 | 3 |
| Total, all-cause mortality | Dose Escalation Cohort 2: 300 mg QD | 1 | 6 |
| Total, all-cause mortality | Dose Escalation Cohort 3: 400 mg QD | 1 | 6 |
| Total, all-cause mortality | Dose Escalation Cohort 4: 600 mg QD | 0 | 6 |
| Total, all-cause mortality | Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM) | 0 | 7 |
| Total, all-cause mortality | Dose Escalation Cohort 6: 1200 mg/Day (600mg BID) | 1 | 6 |
| Total, all-cause mortality | Dose Escalation Cohort 7: 1000 mg/Day (500mg BID) | 0 | 7 |
| Total, all-cause mortality | MEC Cohort 1000 mg/Day (600mg AM, 400mg PM) | 1 | 4 |
| Total, all-cause mortality | PVNS Cohort 1000 mg/Day (600mg AM, 400mg PM) | 0 | 39 |
| Total, all-cause mortality | GIST Cohort 1000 mg/Day (600mg AM, 400mg PM) | 3 | 11 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse event totalsPapers3
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.
For software
Read this trial from software.
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