Recurrent GlioblastomaPhase 2NCT01349036

A Phase 2 Study of PLX3397 in Patients With Recurrent Glioblastoma

A Phase 2 study testing PLX3397 in people with Recurrent Glioblastoma, run by Daiichi Sankyo at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The objective of this study is to evaluate the response of subjects with recurrent glioblastoma to continuous therapy of PLX3397. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Glioblastoma
What is being tested?: PLX3397
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 6 sitesUnited States
Study dates: 3 Dec 2011to 5 Nov 2013
Phase: Phase 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 with a life expectancy of at least 8 weeks
Radiographically proven recurrent (≥ first relapse), intracranial Glioblastoma (GBM)
For all patients, availability of at least 10 unstained slides (or archival tumor block sufficient to generate at least 10 unstained slides) from any previous GBM surgery
Previous treatment with external beam radiation and temozolomide chemotherapy
Before the first dose of PLX3397,adequate recovery from toxicity of prior therapy as follows:
>28 days for cytotoxic therapy >42 days for nitrosoureas >28 days for bevacizumab >7 days for non cytotoxic therapy such as interferon, tamoxifen, thalidomide, cis-retinoic acid, or erlotinib

Show all 10Show fewer

Women of child-bearing potential must have a negative pregnancy test within 7 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.
Karnofsky performance status of ≥60
Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.0 x 109/L, Hgb >9 g/dL, platelet count ≥50 x 109/L, Aspartate aminotransferase/Alanine aminotransferase (AST/ALT) ≤2.5x Upper Limit of Normal (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

Investigational drug use within 28 days of the first dose of PLX3397
GBM progression within 3 months of previous radiation by Response Assessment in Neuro-Oncology (RANO) criteria
History of Grade 2 Common Toxicity Criteria for Adverse Events (CTCAE v4) or greater acute intracranial hemorrhage
Previous failure of bevacizumab or other vascular endothelial growth factor (VEGF) therapy except in a first line setting
History of malignant glioma with co-deletion of 1p/19q
A concurrent active cancer that requires non-surgical therapy (e.g. chemotherapy, radiation, adjuvant therapy). Prior history of other cancer is allowed, as long as there was no active disease within the prior 3 years.

Show all 10Show fewer

Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption
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
corrected QT interval (QTc) ≥450 msec at Screening

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Dana Faber Cancer Institute
Boston, Massachusetts, 02115
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
University California, Los Angeles
Los Angeles, California, 90095
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Huntsman Cancer Institute University of Utah
Salt Lake City, Utah, 84132
University California, San Francisco
San Francisco, California, 94143

Other trials in United States

About this study

Official title: A Phase 2 Study of Orally Administered PLX3397 in Patients With Recurrent Glioblastoma

The objective of this study is to evaluate the response of subjects with recurrent glioblastoma to continuous therapy of PLX3397.

Conditions: Recurrent Glioblastoma
Being tested: PLX3397
Keywords: Glioblastoma, brain cancer
Medical subject headings: Glioblastoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PLX3397Drug
Also called Pexidartinib
Capsules administered once or twice daily, continuous dosing

Study groups in NCT01349036
Study group	Role	What they receive
PLX3397-Cohort 1	Experimental	10 patients with recurrent glioblastoma who require reoperation will be treated with PLX3397 for 7 days prior to surgery and their tumor tissue will be evaluated for pharmacokinetic levels and pharmacodynamic effects. Receives: Drug: PLX3397
PLX3397-Cohort 2	Experimental	30 patients will be orally dosed with PLX3397 continuously on 28 day cycles. Receives: Drug: PLX3397

What is being measured

The primary outcome is the main question the study is designed to answer.

Summary of Response Rates in Participants on Treatment With PLX3397
Response to treatment was evaluated using the Response Assessment in Neuro-Oncology (RANO) criteria. All participants were evaluated for progression free survival (PFS), and overall survival (OS). The six-month PFS rate was defined as the number of subjects with PFS of at least 6-month duration, with PFS measured from the first day of treatment (Cycle 1, Day 1) to the date of the first documented disease progression or date of death, whichever occurs first, over a 6-month period and evaluated using the Kaplan Meier method. The rate of OS was defined as the number of subjects that survived until study exit.
Measured: 6 months post dose
Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15
A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters, include time to maximum concentration (Tmax) and will be calculated from the Cycle 1, Day 15 values.
Measured: Pre-dose and up to 6 post dose during cycle 1, Day 15
Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15
A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters include maximum concentration (Cmax) and will be calculated from the Cycle 1, Day 15 values.
Measured: Pre-dose and up to 6 post dose during cycle 1, Day 15
Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15
A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters include an assessment of area under the curve over 0-4 hours (AUC0-4), and will be calculated from the Cycle 1, Day 15 values.
Measured: Pre-dose and up to 6 post dose during cycle 1, Day 15
Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15
A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters include an assessment of area under the curve over 0-6 hours (AUC0-6), and will be calculated from the Cycle 1, Day 15 values.
Measured: Pre-dose and up to 6 post dose during cycle 1, Day 15

Secondary outcomes (1)

Incidence (Number and Percentage of Participants) With Treatment-Emergent Adverse Events Related to Study Drug Occurring in ≥10% Participants During Treatment With PLX3397 (Safety Population)
Measured: Up to 1 year post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 20115 Nov 2013

First posted6 May 2011 (estimated)
Study start3 Dec 2011
Primary completion5 Nov 2013
Study completion5 Nov 2013

Why it stopped: Business Decision

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 (1)Papers the sponsor has linked to this study.
Other trials for Recurrent 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01349036
Sponsor's protocol ID: PLX108-04
Status last verified: Feb 2020
First submitted: 4 May 2011
Last updated: 3 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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

Lamborn KR, Yung WK, Chang SM, Wen PY, Cloughesy TF, DeAngelis LM, Robins HI, Lieberman FS, Fine HA, Fink KL, Junck L, Abrey L, Gilbert MR, Mehta M, Kuhn JG, Aldape KD, Hibberts J, Peterson PM, Prados MD; North American Brain Tumor Consortium. Progression-free survival: an important end point in evaluating therapy for recurrent high-grade gliomas. Neuro Oncol. 2008 Apr;10(2):162-70. doi: 10.1215/15228517-2007-062. Epub 2008 Mar 4.
PubMed 18356283

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Recurrent Glioblastoma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study of Orally Administered PLX3397 in Patients With Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT01349036
Acronym / sponsor ID: PLX108-04
Conditions: Recurrent Glioblastoma
Keywords: Glioblastoma, brain cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business Decision
Enrolment: 38 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Collaborators: Plexxikon
Study start: 3 Dec 2011 (actual)
Primary completion: 5 Nov 2013 (actual)
Study completion: 5 Nov 2013 (actual)
First posted: 6 May 2011 (estimated)
Results: Posted 9 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to evaluate the response of subjects with recurrent glioblastoma to continuous therapy of PLX3397.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PLX3397-Cohort 1	Experimental	Drug: PLX339710 patients with recurrent glioblastoma who require reoperation will be treated with PLX3397 for 7 days prior to surgery and their tumor tissue will be evaluated for pharmacokinetic levels and pharmacodynamic effects.
PLX3397-Cohort 2	Experimental	Drug: PLX339730 patients will be orally dosed with PLX3397 continuously on 28 day cycles.

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 with a life expectancy of at least 8 weeks
Radiographically proven recurrent (≥ first relapse), intracranial Glioblastoma (GBM)
For all patients, availability of at least 10 unstained slides (or archival tumor block sufficient to generate at least 10 unstained slides) from any previous GBM surgery
Previous treatment with external beam radiation and temozolomide chemotherapy
Before the first dose of PLX3397,adequate recovery from toxicity of prior therapy as follows:

Key exclusion criteria (10 listed)

Investigational drug use within 28 days of the first dose of PLX3397
GBM progression within 3 months of previous radiation by Response Assessment in Neuro-Oncology (RANO) criteria
History of Grade 2 Common Toxicity Criteria for Adverse Events (CTCAE v4) or greater acute intracranial hemorrhage
Previous failure of bevacizumab or other vascular endothelial growth factor (VEGF) therapy except in a first line setting
History of malignant glioma with co-deletion of 1p/19q

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: PexidartinibCapsules administered once or twice daily, continuous dosing	Drug	PLX3397-Cohort 1, PLX3397-Cohort 2

Primary outcome

Summary of Response Rates in Participants on Treatment With PLX3397
Time frame: 6 months post dose
Response to treatment was evaluated using the Response Assessment in Neuro-Oncology (RANO) criteria. All participants were evaluated for progression free survival (PFS), and overall survival (OS). The six-month PFS rate was defined as the number of subjects with PFS of at least 6-month duration, with PFS measured from the first day of treatment (Cycle 1, Day 1) to the date of the first documented disease progression or date of death, whichever occurs first, over a 6-month period and evaluated using the Kaplan Meier method. The rate of OS was defined as the number of subjects that survived until study exit.
Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15
Time frame: Pre-dose and up to 6 post dose during cycle 1, Day 15
A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters, include time to maximum concentration (Tmax) and will be calculated from the Cycle 1, Day 15 values.
Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15
Time frame: Pre-dose and up to 6 post dose during cycle 1, Day 15
A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters include maximum concentration (Cmax) and will be calculated from the Cycle 1, Day 15 values.
Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15
Time frame: Pre-dose and up to 6 post dose during cycle 1, Day 15
A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters include an assessment of area under the curve over 0-4 hours (AUC0-4), and will be calculated from the Cycle 1, Day 15 values.
Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15
Time frame: Pre-dose and up to 6 post dose during cycle 1, Day 15
A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters include an assessment of area under the curve over 0-6 hours (AUC0-6), and will be calculated from the Cycle 1, Day 15 values.

1 secondary outcome

Incidence (Number and Percentage of Participants) With Treatment-Emergent Adverse Events Related to Study Drug Occurring in ≥10% Participants During Treatment With PLX3397 (Safety Population)
Time frame: Up to 1 year post dose

Results and safety

Results posted to the registry on 9 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PLX3397 - Cohort 1 (Surgical)	14	0
PLX3397 - Cohort 2 (Non-surgical)	24	0

Primary outcome: Summary of Response Rates in Participants on Treatment With PLX3397

Time frame: 6 months post dose. Count of participants. Unit: Participants

Measure	Surgical Cohort 1 (N=14) n = 13	Non-Surgical Cohort 2 (N=24) n = 22
Six-month PFS rate	1	2
Overall survival	10	21
Complete response rate	0	0
Partial response rate	0	0
Stable disease rate	3	4
Progressive disease rate	10	18
Not Evaluable	1	2

Population analysed: Response rates were assessed in the modified intent-to-treat population.

Primary outcome: Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15

Time frame: Pre-dose and up to 6 post dose during cycle 1, Day 15. Mean (Standard Deviation). Unit: hours

Measure	PLX3397 - Cohort 1 (Surgical) n = 11	PLX3397 - Cohort 2 (Non-surgical) n = 21
Value	2.09 (1.04)	1.71 (0.90)

Primary outcome: Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15

Time frame: Pre-dose and up to 6 post dose during cycle 1, Day 15. Mean (Standard Deviation). Unit: ng/mL

Measure	PLX3397 - Cohort 1 (Surgical) n = 11	PLX3397 - Cohort 2 (Non-surgical) n = 21
Value	7760 (2330)	8030 (2790)

Primary outcome: Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15

Time frame: Pre-dose and up to 6 post dose during cycle 1, Day 15. Mean (Standard Deviation). Unit: hr*ng/mL

Measure	PLX3397 - Cohort 1 (Surgical) n = 11	PLX3397 - Cohort 2 (Non-surgical) n = 21
Value	24900 (6700)	26100 (9260)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected from after the first dose to 28 days after the last dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PLX3397 - Cohort 1 (Surgical)	8 of 14 (57.1%)	14 of 14 (100%)	0 of 14
PLX3397 - Cohort 2 (Non-surgical)	11 of 24 (45.8%)	22 of 24 (91.7%)	1 of 24

Limitations and caveats (from the sponsor): Study was terminated due to results noted in primary outcome measure 1. The sponsor felt that the PFS 6 goal of 25% (Lamborn, 2008) was unlikely to be met upon further enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18356283Lamborn KR, Yung WK, Chang SM, Wen PY, Cloughesy TF, DeAngelis LM, Robins HI, Lieberman FS, Fine HA, Fink KL, Junck L, Abrey L, Gilbert MR, Mehta M, Kuhn JG, Aldape KD, Hibberts J, Peterson PM, Prados MD; North American Brain Tumor Consortium. Progression-free survival: an important end point in evaluating therapy for recurrent high-grade gliomas. Neuro Oncol. 2008 Apr;10(2):162-70. doi: 10.1215/15228517-2007-062. Epub 2008 Mar 4.
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/

Related trials for Recurrent Glioblastoma

RecruitingPhase 1/2
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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.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PLX3397 in people with Recurrent Glioblastoma, run by Daiichi Sankyo at 6 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 10 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: stopped early, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 phase mean?

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 Jan 2020). 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 Response Rates in Participants on Treatment With PLX3397 (time frame: 6 months post dose). The study lists 5 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 NCT01349036, which also lists 1 linked publication.

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 3 Mar 2020.