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A Study of PX-866 in Patients With Glioblastoma Multiforme at Time of First Relapse or Progression

Study Purpose

The purpose of this study is to find out whether the new drug PX-866 will slow the growth of your glioblastoma multiforme.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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: 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.

Exclusion Criteria:

  • - 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!
  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01259869
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NCIC Clinical Trials Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marshall Pitz
Principal Investigator Affiliation CancerCare Manitoba
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Completed
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Arms & Interventions

Arms

Experimental: PX-866

Interventions

Drug: - PX-866

1 cycle = 8 weeks on study PX-866 - 8mg PO Daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Status

Address

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2

BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

Status

Address

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Status

Address

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9

QEII Health Sciences Centre, Halifax, Nova Scotia, Canada

Status

Address

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7

London Regional Cancer Program, London, Ontario, Canada

Status

Address

London Regional Cancer Program

London, Ontario, N6A 4L6

Toronto, Ontario, Canada

Status

Address

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9

Allan Blair Cancer Centre, Regina, Saskatchewan, Canada

Status

Address

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1