GlioblastomaPhase 2NCT01259869
A Study of PX-866 in Patients With Glioblastoma Multiforme at Time of First Relapse or Progression
A Phase 2 study testing PX-866 in people with Glioblastoma, run by NCIC Clinical Trials Group at 7 sites in Canada.
Trial summary
The purpose of this study is to find out whether the new drug PX-866 will slow the growth of your glioblastoma multiforme. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- PX-866
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 7 sitesCanada
- Study dates
- 1 Apr 2011to 13 Feb 2015
- 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
- Patients must have histologically confirmed diagnosis of glioblastoma multiforme (GBM), with recurrent or progressive disease following or during primary treatment not curable with standard therapies.
- All patients must have formalin fixed paraffin embedded tissue available for translational studies.
- Presence of bidimensionally measurable enhancing lesions on CT or MRI, with at least one lesion with a minimum dimension of 1 cm x 1 cm (i.e. both dimensions must be ≥ 1.0 cm). Baseline CT or MRI must be done within 14 days prior to registration.
- ECOG performance of 0, 1 or 2.
- Age ≥ 18 years of age. Previous Therapy
- Chemotherapy:
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- Patients may have received prior adjuvant chemotherapy and/or concurrent chemoradiation as part of primary therapy, but must have received no therapy for recurrent/ progressive GBM (i.e. PX-866 must be first treatment for recurrence/ progression). A minimum of 28 days since the last dose of chemotherapy must have elapsed prior to registration.
- Targeted Therapy:
- No prior therapy with a phosphatidylinositol 3-kinase (PI-3K) inhibitor. Other targeted agents are permissible provided they were given as part of front line treatment. A minimum of 56 days (8 weeks) must have elapsed since last day for anti-angiogenic therapy and minimum of 28 days for other targeted agents.
- Radiation:
- Patients may have had prior radiation therapy provided at least 28 days have elapsed from the day of the last fraction of radiation to the date of registration.
- Previous Surgery: Previous surgery is permitted provided that wound healing has occurred and at least 14 days have elapsed prior to registration.
- 5.1.7 Laboratory Requirements (must be done within 7 days prior to registration)
- Hematology:
- Granulocytes (AGC) ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L
- Chemistry:
- Serum creatinine ≤ 1.5 x UNL Total bilirubin ≤ 1.5 x UNL ALT and AST ≤ 1.5 x UNL Glucose ≤ 8.9 mmol/L (≤ Grade 1)
- Women must be post menopausal, surgically sterile or use a reliable form of contraception while on study and for 30 days after discontinuing therapy. Women of childbearing potential must have a pregnancy test taken and proven negative within 7 days prior to registration and must not be lactating.
- Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is provided. A copy of the initial full board REB approval and approved consent form must be sent to the central office. The patient must sign the consent form prior to registration (exception for translations). Please note that the consent form for this study must contain a statement which gives permission for the NCIC CTG and monitoring agencies to review patient records Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.
- Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 2 hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves that the patients registered on this trial will be available for complete documentation of the treatment, adverse events, response assessment and follow-up.
- In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient registration.
Who cannot join
- Patients who have other active malignancies (i.e. documented by imaging, clinical exam or marker) are to be excluded. (Please call NCIC CTG if any questions about the interpretation of this criterion).
- Known HIV-positive patients.
- Uncontrolled diabetes mellitus.
- Patients should be on a stable dose of steroid (i.e. no change in dose for 2 weeks prior to registration) when entered on study. Patients recently started on steroids or whose steroid dose was increased in the recent past should not be started on protocol treatment until at least 2 weeks have passed from the time of steroid dose increment or initiation. Under these circumstances, baseline CT or MRI scan for purposes of assessment of response to protocol treatment should be done at the time of initiation of protocol therapy (i.e., these patients must be re-imaged to control for steroid effects).
- Note:
- The idea behind this is to restrict entry to a subset of patients who are not rapidly changing: especially rapidly deteriorating. If a patient being worked up for the trial appears to need to have steroid introduced or increased, the patient should be treated as is medically appropriate (i.e., have the steroid introduced or increased). Steroid should NOT be withheld if clinically indicated just so that patients can be registered on study!
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- Patients with upper gastrointestinal or other conditions that would preclude compliance or absorption of oral medication are not eligible.
- Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
- Patients are not eligible if they have a known hypersensitivity to the study drugs or their components.
- Patients who have had prior treatment with a PI3 kinase inhibitor.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
London Regional Cancer Program
London, Ontario, N6A 4L6
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: A Phase II Study of PX-866 in Patients With Glioblastoma Multiforme at Time of First Relapse or Progression
The purpose of this study is to find out whether the new drug PX-866 will slow the growth of your glioblastoma multiforme.
- Conditions
- Glioblastoma
- Being tested
- PX-866
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PX-866Drug
1 cycle = 8 weeks on study PX-866 - 8mg PO Daily
| Study group | Role | What they receive |
|---|---|---|
| PX-866 | Experimental | Not described Receives: Drug: PX-866 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Assessed by evaluation of change in product of bidimensional measurement of enhancing brain tumour on CT scan or MRI
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study start1 Apr 2011
- Primary completion29 Oct 2014
- Study completion13 Feb 2015
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 GlioblastomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- Cascadian Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Marshall Pitz, Study chair, CancerCare Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259869
- Sponsor's protocol ID
- I204
- Status last verified
- May 2020
- First submitted
- 9 Dec 2010
- Last updated
- 22 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pitz MW, Eisenhauer EA, MacNeil MV, Thiessen B, Easaw JC, Macdonald DR, Eisenstat DD, Kakumanu AS, Salim M, Chalchal H, Squire J, Tsao MS, Kamel-Reid S, Banerji S, Tu D, Powers J, Hausman DF, Mason WP. Phase II study of PX-866 in recurrent glioblastoma. Neuro Oncol. 2015 Sep;17(9):1270-4. doi: 10.1093/neuonc/nou365. Epub 2015 Jan 20.
PubMed 25605819
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of PX-866 in Patients With Glioblastoma Multiforme at Time of First Relapse or Progression
- ClinicalTrials.gov ID
- NCT01259869
- Acronym / sponsor ID
- I204
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Collaborators
- Cascadian Therapeutics Inc.
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 29 Oct 2014 (actual)
- Study completion
- 13 Feb 2015 (actual)
- First posted
- 14 Dec 2010 (estimated)
- Results
- Posted 22 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether the new drug PX-866 will slow the growth of your glioblastoma multiforme.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PX-866 | Experimental | Drug: PX-866 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must have histologically confirmed diagnosis of glioblastoma multiforme (GBM), with recurrent or progressive disease following or during primary treatment not curable with standard therapies.
- All patients must have formalin fixed paraffin embedded tissue available for translational studies.
- Presence of bidimensionally measurable enhancing lesions on CT or MRI, with at least one lesion with a minimum dimension of 1 cm x 1 cm (i.e. both dimensions must be ≥ 1.0 cm). Baseline CT or MRI must be done within 14 days prior to registration.
- ECOG performance of 0, 1 or 2.
- Age ≥ 18 years of age. Previous Therapy
Key exclusion criteria (10 listed)
- Patients who have other active malignancies (i.e. documented by imaging, clinical exam or marker) are to be excluded. (Please call NCIC CTG if any questions about the interpretation of this criterion).
- Known HIV-positive patients.
- Uncontrolled diabetes mellitus.
- Patients should be on a stable dose of steroid (i.e. no change in dose for 2 weeks prior to registration) when entered on study. Patients recently started on steroids or whose steroid dose was increased in the recent past should not be started on protocol treatment until at least 2 weeks have passed from the time of steroid dose increment or initiation. Under these circumstances, baseline CT or MRI scan for purposes of assessment of response to protocol treatment should be done at the time of initiation of protocol therapy (i.e., these patients must be re-imaged to control for steroid effects).
- The idea behind this is to restrict entry to a subset of patients who are not rapidly changing: especially rapidly deteriorating. If a patient being worked up for the trial appears to need to have steroid introduced or increased, the patient should be treated as is medically appropriate (i.e., have the steroid introduced or increased). Steroid should NOT be withheld if clinically indicated just so that patients can be registered on study!
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 |
|---|---|---|
| PX-8661 cycle = 8 weeks on study PX-866 - 8mg PO Daily | Drug | PX-866 |
Primary outcome
Objective Response Rate
Time frame: 18 months
Assessed by evaluation of change in product of bidimensional measurement of enhancing brain tumour on CT scan or MRI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25605819Pitz MW, Eisenhauer EA, MacNeil MV, Thiessen B, Easaw JC, Macdonald DR, Eisenstat DD, Kakumanu AS, Salim M, Chalchal H, Squire J, Tsao MS, Kamel-Reid S, Banerji S, Tu D, Powers J, Hausman DF, Mason WP. Phase II study of PX-866 in recurrent glioblastoma. Neuro Oncol. 2015 Sep;17(9):1270-4. doi: 10.1093/neuonc/nou365. Epub 2015 Jan 20.
- Individual participant dataSharing planned: No
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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.
Marshall Pitz study chair
CancerCare Manitoba
7 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 PX-866 in people with Glioblastoma, run by NCIC Clinical Trials Group at 7 sites in Canada.
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 21 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: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. 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 22 May 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?
Objective Response Rate (time frame: 18 months). 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 NCT01259869, 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 22 Aug 2023.