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

NCT01259869 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: I204
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 7

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Assessed by evaluation of change in product of bidimensional measurement of enhancing brain tumour on CT scan or MRI

  18 months

Study Arms (1)

PX-866

EXPERIMENTAL

Drug: PX-866

Interventions

PX-866 DRUG

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

PX-866

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Laboratory Requirements (must be done within 7 days prior to registration)
• Hematology:
• Granulocytes (AGC) ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L

You may not qualify if:

• 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.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• Cascadian Therapeutics Inc.: collaborator

Study Sites (7)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

• 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.

  PMID: 25605819 RESULT

MeSH Terms

Conditions

Glioblastoma

Interventions

PX-866

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Lesley Seymour
• Organization: Canadian Cancer Trials Group

lseymour@ctg.queensu.ca

6135336430

Study Officials

• Marshall Pitz

  CancerCare Manitoba

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 14, 2010
• Study Start: April 1, 2011
• Primary Completion: October 29, 2014
• Study Completion: February 13, 2015
• Last Updated: August 22, 2023
• Results First Posted: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)