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Status:

COMPLETED

BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Glioma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Phase I Part: To determine the maximum tolerated dose (MTD) and pharmacokinetics of BIBW 2992 administered in combination with TMZ in patients with recurrent malignant gliomas (WHO Grade III and IV). ...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Phase I Part:
  • Histologically-confirmed WHO Grade III or IV malignant glioma that is recurrent after prior chemoradiotherapy. Patients with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO Grade III or IV malignant glioma.
  • Age at least 18 years at entry
  • KPS at least 60%
  • Patients must have recovered from previous surgery and chemotherapy.
  • Written informed consent that is consistent with local law and ICH-GCP guidelines.
  • Phase II Part:
  • Histologically-confirmed WHO Grade IV malignant glioma at first episode of recurrence after prior combined chemoradiotherapy. Patients with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO Grade IV malignant glioma and if prior treatment included temozolomide chemotherapy and radiotherapy.
  • Bi-dimensionally measurable disease with a minimum measurement of 1 cm (10 mm) in one diameter on Gd MRI performed within 14 days prior to first treatment (Day 1).
  • Age at least 18 years at entry
  • KPS at least 70%
  • Patients must have recovered from previous surgery and chemotherapy.
  • Written informed consent that is consistent with local law and ICH-GCP guidelines.
  • Patients receiving corticosteroids have to receive a stable or decreasing dose for at least 14 days before start of study treatment.
  • Exclusion criteria:
  • Phase I and Phase II Parts:
  • Less than 12 weeks between radiotherapy and start of study treatment, unless new enhancing lesion outside of radiation field or radiologically progressive on two consecutive MRI scans at least four weeks apart or biopsy-proven recurrence.
  • Less than two weeks from surgical resection (one week from prior stereotactic biopsy) or major surgical procedure.
  • Less than two weeks after previous chemotherapy (6 weeks from nitrosureas).
  • Treatment with other investigational drugs; participation in another clinical study within the past 2 weeks before start of therapy or concomitantly with this study.
  • Progressive disease or toxicity =CTCAEv3 Grade 3 to protracted temozolomide dosing (defined as temozolomide administered more than 5 days/28 day cycle).
  • Active infectious disease requiring intravenous therapy.
  • Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
  • Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
  • Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
  • Patient is \<3 years free of another primary malignancy except: if the other primary malignancy is either not currently clinically significant or does not require active intervention (such as a basal cell skin cancer or a cervical carcinoma in situ). Existence of any other malignant disease is not allowed.
  • Cardiac left ventricular function with resting ejection fraction \<50%.
  • Absolute neutrophil count (ANC) less than 1500/mm3.
  • Platelet count less than 100,000/mm3.
  • Bilirubin greater than 1.5 x upper limit of institutional norm.
  • Aspartate amino transferase (AST) greater than 3 x upper limit of institutional norm.
  • Serum creatinine greater than 1.5 x upper limit of institutional norm.
  • Patients who are sexually active and unwilling to use a medically acceptable method of contraception.
  • Pregnancy or breast-feeding.
  • Patients unable to comply with the protocol.
  • Known pre-existing interstitial lung disease (ILD).
  • Phase I part only:
  • 1\. Less than four weeks from prior treatment with bevacizumab.
  • Phase II Part only:
  • Prior EGFR-directed therapy.
  • Prior bevacizumab therapy.
  • Patients presenting with second or higher number of episodes of recurrence.
  • Requirement of treatment with any of the prohibited concomitant medications listed in Section 4.2.2 (Restrictions regarding concomitant treatment).

Exclusion

    Key Trial Info

    Start Date :

    July 14 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 25 2016

    Estimated Enrollment :

    151 Patients enrolled

    Trial Details

    Trial ID

    NCT00727506

    Start Date

    July 14 2008

    End Date

    May 25 2016

    Last Update

    August 15 2017

    Active Locations (28)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 7 (28 locations)

    1

    1200.36.0016 Boehringer Ingelheim Investigational Site

    Birmingham, Alabama, United States

    2

    1200.36.0012 Boehringer Ingelheim Investigational Site

    Phoenix, Arizona, United States

    3

    1200.36.0005 Boehringer Ingelheim Investigational Site

    Duarte, California, United States

    4

    1200.36.0014 Boehringer Ingelheim Investigational Site

    Los Angeles, California, United States