A Phase 2 Study of PLX3397 in Patients With Recurrent Glioblastoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Plexxikon
ClinicalTrials.gov Identifier:
NCT01349036
First received: May 4, 2011
Last updated: April 3, 2013
Last verified: April 2013

May 4, 2011
April 3, 2013
August 2011
May 2013   (final data collection date for primary outcome measure)
  • Safety-Subject incidence of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Subjects will take oral doses of PLX3397 twice a day. Physical examinations, vital signs, 12-lead electrocardiograms (ECG), adverse events, hematology and serum chemistry will be used to assess safety throughout the study. Adverse events will be monitored and reviewed for safety issues/abnormal changes in the above mentioned tests.
  • Efficacy-6 month progression free survival rate (PFS6), median duration of response, overall survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    After discontinuation of PLX3397 for reasons other than progression of disease, patients will be followed every 3 months, or as clinically indicated, until progression of disease or death is documented.
  • Efficacy-Overall response rate (ORR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Subjects will have an MRI brain scan within 28 days of starting dosing with PLX3397 and then every 8 weeks thereafter. Response to treatment will be evaluated using the Response Assessment in Neuro-Oncology (RANO) criteria.
Same as current
Complete list of historical versions of study NCT01349036 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Phase 2 Study of PLX3397 in Patients With Recurrent Glioblastoma
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Recurrent Glioblastoma
Drug: PLX3397
Capsules administered once or twice daily, continuous dosing
  • Experimental: PLX3397-Cohort 1
    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.
    Intervention: Drug: PLX3397
  • Experimental: PLX3397-Cohort 2
    30 patients will be orally dosed with PLX3397 continuously on 28 day cycles.
    Intervention: Drug: PLX3397
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
September 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patients ≥18 years old with a life expectancy of at least 8 weeks
  • Radiographically proven recurrent (≥ first relapse), intracranial 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

  • 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, 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

Exclusion Criteria:

  • Investigational drug use within 28 days of the first dose of PLX3397
  • GBM progression within 3 months of previous radiation by RANO criteria
  • History of Grade 2 (CTCAE v4) or greater acute intracranial hemorrhage
  • Previous failure of bevacizumab or other 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.
  • 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
  • QTc ≥450 msec at Screening
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01349036
PLX108-04
No
Plexxikon
Plexxikon
Not Provided
Not Provided
Plexxikon
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP