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Adult Anaplastic AstrocytomaPhase 1NCT01234740

Bafetinib in Treating Patients With Recurrent High-Grade Glioma or Brain Metastases

A Phase 1 study testing bafetinib, microdialysis and pharmacological study in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Ependymoma, run by City of Hope Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Bafetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This clinical trial studies bafetinib in treating patients with recurrent high-grade glioma or brain metastases. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bafetinib, microdialysis and pharmacological study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
2 sitesUnited States
Study dates
Dec 2010to Mar 2013
Phase
Phase 1
Are there results?
None posted in the registry

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 radiographic findings consistent with either:
  • Recurrent high-grade glioma, or
  • Metastatic disease to the brain that has progressed after treatment with whole brain radiation therapy or stereotactic radiosurgery; patients who have a resectable brain metastasis as the only site of disease (i.e., no evidence of systemic disease), are not eligible to participate
  • Patients who are in need of a surgical debulking or a stereotactic biopsy for the purpose of diagnosis or differentiating between tumor progression versus treatment-induced effects following radiation therapy +/- chemotherapy will be eligible to participate in the microdialysis part of the study prior to beginning cycle 1 of bafetinib if the study neurosurgeon thinks there is a likelihood of being able to place the microdialysis catheter into residual tumor (enhancing brain tissue)
  • Patients who choose not to participate in the microdialysis part of the study may enroll in the study and start treatment at cycle 1 of bafetinib
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for 3 months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
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  • Patients must have a Karnofsky Performance Status (KPS) >= 60%
  • If corticosteroids are required for controlling cerebral edema, patients must be on a stable dose for at least 1 week prior to enrollment
  • Patients must not be taking any hepatic enzyme-inducing anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone, oxcarbazepine) for at least 2 weeks prior to enrollment
  • Absolute neutrophil count >= 1500 cells/mm^3
  • Platelet count >= 100,000 cells/mm^3
  • Total bilirubin =< 2.0 mg/dl
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 3 times the institutional upper limit of normal
  • Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 3 times the institutional upper limit of normal
  • Serum creatinine =< 1.5 x the institutional upper limit of normal
  • QTc interval < 480 msec on electrocardiogram (ECG)
  • All subjects must have the ability to understand and the willingness to sign a written informed consent
  • Patients must have recovered from any toxicity of prior therapies (including brain radiation); an interval of at least 6 weeks must have elapsed since the completion of a nitrosourea-containing chemotherapy regimen; patients who have undergone a recent craniotomy cannot begin bafetinib until at least 2 weeks after the surgery

Who cannot join

  • Patients who are currently receiving chemotherapy or are enrolled in another treatment clinical trial
  • Patients with a coagulopathy or bleeding disorder
  • Patients on anticoagulant drug therapy or medications that inhibit platelet function, such as ibuprofen or other non-steroidal anti-inflammatory drugs
  • Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines
  • Clinically significant cardiac arrhythmias
  • Patients taking a drug that can prolong the QT interval; if a potential study patient is taking one of the prohibited drugs but s/he can safely stop it, then a washout period of >= 7 days is required prior to starting bafetinib
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  • History or signs of active coronary artery disease with or without angina pectoris
  • Patients who have a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol or may not be able to comply with the safety monitoring requirements of the study
  • Human immunodeficiency virus (HIV)-positive patients receiving anti-retroviral therapy are excluded from the study due to the possibility of pharmacokinetic (PK) interactions with bafetinib; however, patients will not be routinely screened for HIV
  • Female patients who are pregnant or breast-feeding
  • Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals
  • Patients who have not recovered from the toxicities of prior chemotherapy or radiotherapy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • City of Hope Medical Center

    Duarte, California, 91010

  • South Pasadena Cancer Center

    South Pasadena, California, 91030

Other trials in United States

About this study

Official title: BAFETINIB-P1-GBM-01: A Pilot Study Using Intracerebral Microdialysis to Determine the Neuropharmacokinetics of Bafetinib in Patients With Recurrent Brain Tumors

RATIONALE: Bafetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This clinical trial studies bafetinib in treating patients with recurrent high-grade glioma or brain metastases.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the neuropharmacokinetics (nPK) and systemic levels of bafetinib in patients with recurrent malignant brain tumors.

SECONDARY OBJECTIVES:

  1. To investigate the intrapatient variability of nPK parameters as assessed by intracerebral microdialysis.

II. To document the toxicity of bafetinib in this cohort of patients. III. To describe the response rate, progression-free survival, and overall survival in patients with malignant brain tumors treated with bafetinib.

IV. To assess for the expression of Lyn and Fyn kinases and phosphorylation status in pre-treatment tumor samples.

OUTLINE:Patients undergo intracerebral microdialysis during debulking craniotomy or stereotactic biopsy. Beginning 24 hours later, patients receive oral bafetinib twice daily for 1 day. Beginning at least 2 weeks after craniotomy or 1 week after biopsy, patients continue to receive oral bafetinib twice daily in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then every 8 weeks thereafter.

Being tested
bafetinib, microdialysis, pharmacological study, liquid chromatography, mass spectrometry
Keywords
Los Angeles
Medical subject headings
Astrocytoma, Ependymoma, Oligodendroglioma, Glioblastoma, Gliosarcoma, Glioma, Brain Neoplasms

What participants receive

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

  • bafetinibDrug

    Also called dual Bcr-Abl/Lyn tyrosine kinase inhibitor INNO-406, INNO-406, NS-187

    Given orally

  • microdialysisProcedure or surgery

    Catheter placed intracerebrally during debulking craniotomy or stereotactic biopsy

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • liquid chromatographyOther

    Also called LC

    Correlative studies

  • mass spectrometryOther

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

  • protein expression analysisGenetic

    Correlative studies

  • western blottingGenetic

    Also called Blotting, Western, Western Blot

    Correlative studies

  • immunohistochemistry staining methodOther

    Also called immunohistochemistry

    Correlative studies

  • therapeutic conventional surgeryProcedure or surgery

    debulking craniotomy

Study groups in NCT01234740
Study groupRoleWhat they receive
Arm IExperimentalPatients undergo intracerebral microdialysis during debulking craniotomy or stereotactic biopsy. Beginning 24 hours later, patients receive oral bafetinib twice daily for 1 day. Beginning at least 2 weeks after surgery, patients continue to receive oral bafetinib twice daily in the absence of disease progression or unacceptable toxicity.
Receives: Drug: bafetinib; Procedure: microdialysis; Other: pharmacological study; Other: liquid chromatography; Other: mass spectrometry; Other: laboratory biomarker analysis; Genetic: protein expression analysis; Genetic: western blotting; Other: immunohistochemistry staining method; Procedure: therapeutic conventional surgery

What is being measured

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

  1. Area-under-the-concentration-time-curve (AUC) of bafetinib in dialysate

    Measured: every hour for 24 hours after first dose of bafetinib

  2. Peak concentration (Cmax) of bafetinib in dialysate

    Measured: every hour for 24 hours after first dose of bafetinib

  3. AUC of bafetinib in plasma

    Measured: 1, 2, 3, 4, 6, 8, and 12 hours after the first dose of bafetinib and then 1, 2, 3, 4, 6, 8, and 12 hours after the second dose of bafetinib

  4. Cmax of bafetinib in plasma

    Measured: 1, 2, 3, 4, 6, 8, and 12 hours after the first dose of bafetinib and then 1, 2, 3, 4, 6, 8, and 12 hours after the second dose of bafetinib

Secondary outcomes (5)

  1. Determination of adverse events associated with bafetinib in patient with recurrent malignant brain tumors

    Measured: 30 days after last dose of bafetinib

  2. Response rate in patients with malignant brain tumors treated with bafetinib

    Measured: 30 days after last dose of bafetinib

  3. Progression-free survival in patients with malignant brain tumors treated with bafetinib

    Measured: 1 year after last dose of bafetinib

  4. Overall survival in patients with malignant brain tumors treated with bafetinib

    Measured: 2 years after last dose of bafetinib

  5. Assessment for expression of Lyn and Fyn kinases and phosphorylation status in pre-treatment tumor samples.

    Measured: Pre-treatment tumor samples

Timeline

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

  1. First posted4 Nov 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01234740
Sponsor's protocol ID
10134
Other IDs
NCI-2010-01963
Status last verified
Apr 2018
First submitted
28 Sep 2010
Last updated
17 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Portnow J, Badie B, Markel S, Liu A, D'Apuzzo M, Frankel P, Jandial R, Synold TW. A neuropharmacokinetic assessment of bafetinib, a second generation dual BCR-Abl/Lyn tyrosine kinase inhibitor, in patients with recurrent high-grade gliomas. Eur J Cancer. 2013 May;49(7):1634-40. doi: 10.1016/j.ejca.2013.01.001. Epub 2013 Feb 4.

    PubMed 23380277

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing bafetinib, microdialysis and pharmacological study in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Ependymoma, run by City of Hope Medical Center at 2 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 18 inclusion and 12 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 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Area-under-the-concentration-time-curve (AUC) of bafetinib in dialysate (time frame: every hour for 24 hours after first dose of bafetinib). The study lists 4 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 NCT01234740, 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 17 Apr 2018.

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