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BIBW 2992 With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, December 2008
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00727506
  Purpose

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).

Phase II Part: To estimate the efficacy and safety of BIBW 2992 monotherapy and BIBW 2992 / TMZ combination therapy compared to TMZ monotherapy (three treatment arms) in patients with recurrent GBM. To evaluate molecular determinants of response to BIBW 2992.


Condition Intervention Phase
Glioma
Drug: BIBW 2992
Drug: TMZ
Phase II

Drug Information available for: Temozolomide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase I/II Trial of BIBW 2992 in Treating Patients With Recurrent Glioblastoma Multiforme

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Phase I Part: Occurrence of Dose limiting toxicity (DLT). Phase II Part: 6 month progression free survival rate. [ Time Frame: Undue toxicity or progression. ]

Secondary Outcome Measures:
  • Pharmacokinetics Safety Objective tumor response PFS Molecular determinants [ Time Frame: Undue toxicity or progression. ]

Estimated Enrollment: 140
Study Start Date: July 2008
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically-confirmed WHO Grade III or IV malignant glioma that is recurrent (Part II 1st recurrence only) after prior chemoradiotherapy. Patients with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO Grade III or IV malignant glioma. (Part II: Grade IV only)
  2. 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). (Part II only).
  3. Age 18 years at entry
  4. KPS 60% (70% Part II)
  5. Patients must have recovered from previous surgery and chemotherapy.
  6. Written informed consent that is consistent with local law and ICH-GCP guidelines.

Exclusion Criteria:

Phase I Part:

  1. 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.
  2. Less than two weeks from surgical resection (one week from prior stereotactic biopsy) or major surgical procedure.
  3. Less than two weeks after previous chemotherapy (6 weeks from nitrosureas).
  4. Less than four weeks from prior treatment with bevacizumab.
  5. Treatment with other investigational drugs; participation in another clinical study within the past 2 weeks before start of therapy or concomitantly with this study.
  6. Progressive disease or toxicity CTCAEv3 Grade 3 to protracted temozolomide dosing (defined as temozolomide administered more than 5 days/28 day cycle).
  7. Active infectious disease requiring intravenous therapy.
  8. Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
  9. Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
  10. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
  11. 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.
  12. Cardiac left ventricular function with resting ejection fraction <50%.
  13. Absolute neutrophil count (ANC) less than 1500/mm3.
  14. Platelet count less than 100,000/mm3.
  15. Bilirubin greater than 1.5 x upper limit of institutional norm.
  16. Aspartate amino transferase (AST) greater than 3 x upper limit of institutional norm.
  17. Serum creatinine greater than 1.5 x upper limit of institutional norm.
  18. Patients who are sexually active and unwilling to use a medically acceptable method of contraception.
  19. Pregnancy or breast-feeding.
  20. Patients unable to comply with the protocol.

Phase II part only:

  1. Prior EGFR-directed therapy.
  2. Patients presenting with second or higher number of episodes of recurrence.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727506

Contacts
Contact: Boehringer Ingelheim Study Coordinator 800-542-6257 ext Option 4 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, Alabama
1200.36.0016 Boehringer Ingelheim Investigational Site Not yet recruiting
Birmingham, Alabama, United States
United States, Arizona
1200.36.0012 Boehringer Ingelheim Investigational Site Recruiting
Phoenix, Arizona, United States
United States, California
1200.36.0005 Boehringer Ingelheim Investigational Site Recruiting
Duarte, California, United States
1200.36.0014 Boehringer Ingelheim Investigational Site Recruiting
Los Angeles, California, United States
United States, Colorado
1200.36.0013 Boehringer Ingelheim Investigational Site Not yet recruiting
Aurora, Colorado, United States
United States, Indiana
1200.36.0015 Boehringer Ingelheim Investigational Site Not yet recruiting
Indianapolis, Indiana, United States
United States, Kentucky
1200.36.0008 Boehringer Ingelheim Investigational Site Recruiting
Louisville, Kentucky, United States
United States, Massachusetts
1200.36.0002 Boehringer Ingelheim Investigational Site Not yet recruiting
Boston, Massachusetts, United States
United States, Michigan
1200.36.0003 Boehringer Ingelheim Investigational Site Recruiting
Detroit, Michigan, United States
United States, New Hampshire
1200.36.0004 Boehringer Ingelheim Investigational Site Not yet recruiting
Lebanon, New Hampshire, United States
United States, New York
1200.36.0009 Boehringer Ingelheim Investigational Site Not yet recruiting
New York, New York, United States
1200.36.0018 Boehringer Ingelheim Investigational Site Not yet recruiting
New York, New York, United States
United States, North Carolina
1200.36.0001 Boehringer Ingelheim Investigational Site Recruiting
Durham, North Carolina, United States
United States, South Carolina
1200.36.0007 Boehringer Ingelheim Investigational Site Recruiting
Charleston, South Carolina, United States
United States, Texas
1200.36.0017 Boehringer Ingelheim Investigational Site Recruiting
Dallas, Texas, United States
1200.36.0010 Boehringer Ingelheim Investigational Site Not yet recruiting
Houston, Texas, United States
United States, Virginia
1200.36.0011 Boehringer Ingelheim Investigational Site Recruiting
Charlotteville, Virginia, United States
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1200.36
Study First Received: July 31, 2008
Last Updated: December 10, 2008
ClinicalTrials.gov Identifier: NCT00727506  
Health Authority: Canada: Health Canada, The Health Products and Food Branch;   United States: Food and Drug Administration

Study placed in the following topic categories:
Neuroectodermal Tumors
Glioblastoma
Glioblastoma multiforme
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Temozolomide
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 14, 2009