Patients With Newly Diagnosed GlioblastomaPhase 1/2NCT01790503
A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma
A Phase 1/2 study testing PLX3397, Radiation Therapy and Temozolomide in people with Patients With Newly Diagnosed Glioblastoma, run by Daiichi Sankyo at 9 sites in United States.
Trial summary
The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed glioblastoma (GBM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Newly Diagnosed Glioblastoma
- What is being tested?
- PLX3397, Radiation Therapy and Temozolomide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 9 sitesUnited States
- Study dates
- 18 Jul 2013to 4 Mar 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥18 years old.
- Histologically confirmed definitive GBM or gliosarcoma by partial or complete surgical resection (i.e. not by biopsy only) within 5 weeks prior to PLX3397 administration (C1D1). Tumor must have a supratentorial component. For all patients, availability of a surgical paraffin tumor block sufficient to generate at least 20 unstained slides; or, if a paraffin tumor block is unavailable, at least 20 unstained slides.
- The patient must have recovered from the effects of surgery, post-operative infection, and other complications before study registration.
- A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days (preferably 14 days) prior to C1D1.
- Patients unable to undergo MR imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality.
- Patients must receive RT at the participating institution.
Show all 10Show fewer
- Women of child-bearing potential must have a negative pregnancy test within 14 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug, and for 3 months after the last dose.
- Karnofsky performance status of ≥70.
- Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.5x 109/L, Hgb >10 g/dL, platelet count ≥100 x 109/L, AST/ALT ≤2.5x ULN, creatinine ≤1.5x ULN).
- Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.
Who cannot join
- Evidence of recurrent GBM or metastases detected outside of the cranial vault.
- Investigational drug use within 28 days of the first dose of PLX3397 or concurrently.
- Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment.
- Prior radiation or chemotherapy for glioblastoma or glioma.
- Prior chemotherapy or radiosensitizers for cancer of the head and neck (except for T1 glottic cancer) that would result in an overlap of radiation fields.
- Prior allergic reaction to temozolomide.
Show all 13Show fewer
- History of Grade 2 (CTCAE v4) or greater acute intracranial hemorrhage.
- Active cancer (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g. chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix.
- Chronic active hepatitis B or C.
- Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption of study drug.
- Patients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.
- Women of child-bearing potential who are pregnant or breast feeding.
- At Screening QTcF ≥450 msec for males and ≥470 msec for females.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Northwestern Memorial Hospital
Chicago, Illinois, 60611
James Cancer Hospital/Ohio State University
Columbia, Ohio, 43210
Henry Ford Hospital
Detroit, Michigan, 48202
Columbia University Medical Center
New York, New York, 10032
Huntsman Cancer Institute University of Utah
Salt Lake City, Utah, 84132
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: An Open Label Phase 1b/2 Study of Orally Administered PLX3397 in Combination With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed glioblastoma (GBM).
Read the detailed description
Study drug will be administered twice daily for 7 days prior to the initiation of RT (radiation therapy)and will continue twice daily during the course of RT. The RT schedule will be once daily for 5 days per week for 6 weeks (total radiation dose of 60 Gy. Oral temozolomide will be administered once daily (7 days per week) for the duration of RT. Four weeks after the completion of the course of RT, patients will be started on once-daily adjuvant temozolomide (Day 1-5 of a 28 day cycle) and PLX3397 twice daily (28 days of a 28 day cycle) for up to 12 cycles in the absence of progressive disease or unacceptable toxicities. After discontinuation of study drug, patients will continue to be followed for OS every 6 months. For patients participating in the run-in Phase 1b of the study, intra patient dose escalation will be permitted after a RP2D has been established. The Phase 2 portion of the study will enroll patients to be treated with PLX3397 at RP2D.
For the Phase 1b portion of the study, 2 cohorts (800 mg/day and 1000 mg/day) are planned to be enrolled at approximately 7-10 sites. Each cohort will consist of approximately 7 patients. Therefore, a minimum of 14 patients are planned to be enrolled in Phase 1b. Additional patients may be required for replacement patients, or if lower dose cohorts (600 mg or 400 mg) are required. For the Phase 2 portion of the study, enrollment is planned to include approximately 44 patients.
- Being tested
- PLX3397, Radiation Therapy, Temozolomide
- Keywords
- glioblastoma, GBM
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLX3397Drug
Also called Pexidartinib
Radiation TherapyRadiation
TemozolomideDrug
Also called TMZ, Temodar
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b dose escalation - 600mg/day PLX3397 cohort | Experimental | 600mg/day PLX3397, Radiation Therapy, and Temozolomide Receives: Drug: PLX3397; Radiation: Radiation Therapy; Drug: Temozolomide |
| Phase 1b dose escalation - 800mg/day PLX3397 | Experimental | 800mg/day PLX3397, Radiation Therapy, and Temozolomide Receives: Drug: PLX3397; Radiation: Radiation Therapy; Drug: Temozolomide |
| Phase 1b dose escalation - 1000 mg/day PLX3397 cohort | Experimental | 1000 mg/day PLX3397, Radiation Therapy, and Temozolomide Receives: Drug: PLX3397; Radiation: Radiation Therapy; Drug: Temozolomide |
| Phase 2 - Recommended phase 2 dose of PLX3397 | Experimental | Recommended phase 2 dose of PLX3397 (800mg/day), Radiation therapy, and Temozolomide Receives: Drug: PLX3397; Radiation: Radiation Therapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group
Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method.
Measured: Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.
Summary of the Median Progression-free Survival (mPFS) in the Study Group Compared With Historical Control From Medical Literature
mPFS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure.
Measured: Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.
Secondary outcomes (9)
Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method. mPFS was analyzed by age group, extent of surgery, baseline Karnofsky Performance Status (KPS), and O6-methylguanine-DNA methyltransferase status (MGMT).
The scale range for the baseline Karnofsky Performance Status is from 0-100, with 0 indicating that the participant is dead and 100 indicating that the participant is Normal no complaints, no evidence of disease. The higher the number, the better the outcome.
Measured: Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.
Summary of the Overall Survival in The Study Population
Overall Survival (OS) was defined as the number of days from the first day of treatment (C1D1) to the date of death and analyzed using a non-parametric Kaplan Meier method.
Measured: Assessed from date of first dose administered to date of death from any cause, assessed up to 4 years 4 months
Summary of the Overall Survival in the Study Group Compared With Historical Control From Medical Literature
Overall Survival was calculated using a parametric model. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure
Measured: Assessed from date of first dose administered to the date of death from any cause, assessed up to 4 years 4 months.
Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Overall Survival was calculated using a non-parametric Kaplan-Meier analysis method. Median OS was analyzed by age group, extent of surgery, baseline Karnofsky Performance Status (KPS), and O6-methylguanine-DNA methyltransferase status (MGMT).
The scale range for the baseline Karnofsky Performance Status is from 0-100, with 0 indicating that the participant is dead and 100 indicating that the participant is Normal no complaints, no evidence of disease. The higher the number, the better the outcome.
Measured: Assessed from date of first dose administered to the date of death from any cause, assessed up to 4 years 4 months.
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Best Overall Response (based on the RANO response) was defined as the highest overall response recorded from the start of study treatment until the end of treatment. Per the Response Assessment in Neuro-Oncology (RANO) criteria for measurable lesions and assessed by Cranial MRI scan, summarized as: Complete Response (CR), Disappearance of all enhancing disease (measurable and non-measurable); Partial Response (PR), >=50% decrease of all measurable enhancing lesions; Stable disease, does not qualify for complete response, partial response, or progression, and progression, >25% increase in enhancing lesions despite stable or increasing steroid use or any new lesions.
Measured: Assessed from Baseline and every 8 weeks, up to 4 years 4 months
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Measured: Baseline up to 30 days after last dose, up to 4 years 4 months
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Measured: Baseline up to 30 days after last dose, up to 4 years 4 months
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
Measured: Baseline up to 30 days after last dose, up to 4 years 4 months
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Measured: Baseline up to 30 days after last dose, up to 4 years 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study start18 Jul 2013
- Primary completion3 Nov 2017
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients With Newly Diagnosed GlioblastomaStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Plexxikon
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790503
- Sponsor's protocol ID
- PLX108-08
- Status last verified
- Jun 2020
- First submitted
- 7 Feb 2013
- Last updated
- 30 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Publications
Gilbert MR, Wang M, Aldape KD, Stupp R, Hegi ME, Jaeckle KA, Armstrong TS, Wefel JS, Won M, Blumenthal DT, Mahajan A, Schultz CJ, Erridge S, Baumert B, Hopkins KI, Tzuk-Shina T, Brown PD, Chakravarti A, Curran WJ Jr, Mehta MP. Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial. J Clin Oncol. 2013 Nov 10;31(32):4085-91. doi: 10.1200/JCO.2013.49.6968. Epub 2013 Oct 7.
PubMed 24101040Gilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, Colman H, Chakravarti A, Pugh S, Won M, Jeraj R, Brown PD, Jaeckle KA, Schiff D, Stieber VW, Brachman DG, Werner-Wasik M, Tremont-Lukats IW, Sulman EP, Aldape KD, Curran WJ Jr, Mehta MP. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):699-708. doi: 10.1056/NEJMoa1308573.
PubMed 24552317
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 1b/2 Study of Orally Administered PLX3397 in Combination With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT01790503
- Acronym / sponsor ID
- PLX108-08
- Keywords
- glioblastoma, GBM
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Plexxikon
- Study start
- 18 Jul 2013 (actual)
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Posted 9 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed glioblastoma (GBM).
Detailed description
Study drug will be administered twice daily for 7 days prior to the initiation of RT (radiation therapy)and will continue twice daily during the course of RT. The RT schedule will be once daily for 5 days per week for 6 weeks (total radiation dose of 60 Gy. Oral temozolomide will be administered once daily (7 days per week) for the duration of RT. Four weeks after the completion of the course of RT, patients will be started on once-daily adjuvant temozolomide (Day 1-5 of a 28 day cycle) and PLX3397 twice daily (28 days of a 28 day cycle) for up to 12 cycles in the absence of progressive disease or unacceptable toxicities. After discontinuation of study drug, patients will continue to be followed for OS every 6 months. For patients participating in the run-in Phase 1b of the study, intra patient dose escalation will be permitted after a RP2D has been established. The Phase 2 portion of the study will enroll patients to be treated with PLX3397 at RP2D.
For the Phase 1b portion of the study, 2 cohorts (800 mg/day and 1000 mg/day) are planned to be enrolled at approximately 7-10 sites. Each cohort will consist of approximately 7 patients. Therefore, a minimum of 14 patients are planned to be enrolled in Phase 1b. Additional patients may be required for replacement patients, or if lower dose cohorts (600 mg or 400 mg) are required. For the Phase 2 portion of the study, enrollment is planned to include approximately 44 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1b dose escalation - 600mg/day PLX3397 cohort | Experimental | Drug: PLX3397, Radiation: Radiation Therapy, Drug: Temozolomide600mg/day PLX3397, Radiation Therapy, and Temozolomide |
| Phase 1b dose escalation - 800mg/day PLX3397 | Experimental | Drug: PLX3397, Radiation: Radiation Therapy, Drug: Temozolomide800mg/day PLX3397, Radiation Therapy, and Temozolomide |
| Phase 1b dose escalation - 1000 mg/day PLX3397 cohort | Experimental | Drug: PLX3397, Radiation: Radiation Therapy, Drug: Temozolomide1000 mg/day PLX3397, Radiation Therapy, and Temozolomide |
| Phase 2 - Recommended phase 2 dose of PLX3397 | Experimental | Drug: PLX3397, Radiation: Radiation Therapy, Drug: TemozolomideRecommended phase 2 dose of PLX3397 (800mg/day), Radiation therapy, and Temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients ≥18 years old.
- Histologically confirmed definitive GBM or gliosarcoma by partial or complete surgical resection (i.e. not by biopsy only) within 5 weeks prior to PLX3397 administration (C1D1). Tumor must have a supratentorial component. For all patients, availability of a surgical paraffin tumor block sufficient to generate at least 20 unstained slides; or, if a paraffin tumor block is unavailable, at least 20 unstained slides.
- The patient must have recovered from the effects of surgery, post-operative infection, and other complications before study registration.
- A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days (preferably 14 days) prior to C1D1.
- Patients unable to undergo MR imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality.
Key exclusion criteria (13 listed)
- Evidence of recurrent GBM or metastases detected outside of the cranial vault.
- Investigational drug use within 28 days of the first dose of PLX3397 or concurrently.
- Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment.
- Prior radiation or chemotherapy for glioblastoma or glioma.
- Prior chemotherapy or radiosensitizers for cancer of the head and neck (except for T1 glottic cancer) that would result in an overlap of radiation fields.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLX3397Also: Pexidartinib | Drug | Phase 1b dose escalation - 1000 mg/day PLX3397 cohort, Phase 1b dose escalation - 600mg/day PLX3397 cohort, Phase 1b dose escalation - 800mg/day PLX3397, Phase 2 - Recommended phase 2 dose of PLX3397 |
| Radiation Therapy | Radiation | Phase 1b dose escalation - 1000 mg/day PLX3397 cohort, Phase 1b dose escalation - 600mg/day PLX3397 cohort, Phase 1b dose escalation - 800mg/day PLX3397, Phase 2 - Recommended phase 2 dose of PLX3397 |
| TemozolomideAlso: TMZ, Temodar | Drug | Phase 1b dose escalation - 1000 mg/day PLX3397 cohort, Phase 1b dose escalation - 600mg/day PLX3397 cohort, Phase 1b dose escalation - 800mg/day PLX3397, Phase 2 - Recommended phase 2 dose of PLX3397 |
Primary outcome
Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group
Time frame: Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.
Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method.
Summary of the Median Progression-free Survival (mPFS) in the Study Group Compared With Historical Control From Medical Literature
Time frame: Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.
mPFS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure.
9 secondary outcomes
Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Time frame: Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.
Summary of the Overall Survival in The Study Population
Time frame: Assessed from date of first dose administered to date of death from any cause, assessed up to 4 years 4 months
Summary of the Overall Survival in the Study Group Compared With Historical Control From Medical Literature
Time frame: Assessed from date of first dose administered to the date of death from any cause, assessed up to 4 years 4 months.
Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Time frame: Assessed from date of first dose administered to the date of death from any cause, assessed up to 4 years 4 months.
Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose
Time frame: Assessed from Baseline and every 8 weeks, up to 4 years 4 months
Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population
Time frame: Baseline up to 30 days after last dose, up to 4 years 4 months
Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population
Time frame: Baseline up to 30 days after last dose, up to 4 years 4 months
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population
Time frame: Baseline up to 30 days after last dose, up to 4 years 4 months
Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population
Time frame: Baseline up to 30 days after last dose, up to 4 years 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24101040Gilbert MR, Wang M, Aldape KD, Stupp R, Hegi ME, Jaeckle KA, Armstrong TS, Wefel JS, Won M, Blumenthal DT, Mahajan A, Schultz CJ, Erridge S, Baumert B, Hopkins KI, Tzuk-Shina T, Brown PD, Chakravarti A, Curran WJ Jr, Mehta MP. Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial. J Clin Oncol. 2013 Nov 10;31(32):4085-91. doi: 10.1200/JCO.2013.49.6968. Epub 2013 Oct 7.
- Results publication: PubMed 24552317Gilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, Colman H, Chakravarti A, Pugh S, Won M, Jeraj R, Brown PD, Jaeckle KA, Schiff D, Stieber VW, Brachman DG, Werner-Wasik M, Tremont-Lukats IW, Sulman EP, Aldape KD, Curran WJ Jr, Mehta MP. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):699-708. doi: 10.1056/NEJMoa1308573.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PLX3397, Radiation Therapy and Temozolomide in people with Patients With Newly Diagnosed Glioblastoma, run by Daiichi Sankyo at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group (time frame: Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years 4 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01790503, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.