AQ4N in Combination With Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma Multiforme
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00394628|
Recruitment Status : Unknown
Verified May 2007 by Novacea.
Recruitment status was: Recruiting
First Posted : November 1, 2006
Last Update Posted : May 30, 2007
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Phase 1b of the study, will evaluate the safety and tolerability of AQ4N treatment at three different dose levels.
Phase 2a of the study, will further evaluate the safety, tolerability, and in addition efficacy of AQ4N treatment at a tolerated dose selected from Phase 1b.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Drug: AQ4N Drug: Temozolomide Procedure: Radiotherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2a, Multicenter, Open-Label Study of AQ4N in Combination With Radiation Therapy and Temozolomide, to Evaluate the Safety, Tolerability, and Efficacy in Subjects With Newly Diagnosed Glioblastoma Multiforme|
|Study Start Date :||October 2006|
- Phase 1b: Evaluation of the safety and tolerability of AQ4N in combination with radiation therapy and temozolomide (TEMODAR®)for the treatment of glioblastoma multiforme (GBM). Dose levels for the Phase 2a will be selected.
- Phase 2a: Rate of progression-free survival at 6 months.
- Phase 2a: Rate of progression-free survival at 12 months
- Percent of subjects alive at 12 months
- Duration of progression-free survival
- Time to progression
- Duration of overall survival
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Histologically proven intracranial Glioblastoma Multiforme (GBM) with diagnosis established by biopsy or resection within 5 weeks prior to enrollment.
- Cranial MRI or contrast CT performed 14 days prior to study entry. Subjects without measurable or assessable disease are eligible.
- Plan to begin partial brain radiotherapy within 24-72 hours after beginning AQ4N, and within 35 days (5 weeks) of the surgery, or if surgery cannot be performed, the biopsy that confirms GBM diagnosis. Radiation therapy must be given by external beam to a partial brian field in daily fractions of 2.0 Gy, to a planned total dose to the tumor of 60.0 Gy over 6 weeks.
- Age equal to or greater than 18 years and life expectancy > 10 weeks.
- Karnofsky performance status of > 60.
- Adequate bone marrow, liver and renal functions (tests must be performed within 14 days prior to enrollment).
- Negative serum or urine pregnancy test (females of childbearing potential only).
- Willingness to use effective contraception (both males and females of child-bearing potential) throughout the study and for at least 2 months after study treatment.
- Able and willing to give informed consent.
- Previous radiotherapy to the brain.
- Previous cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy directed against the brain tumor. Subjects who received Gliadel wafers will be excluded.
- Subjects previously treated with enzyme-induced antiepileptic drugs (EIAEDs) must have discontinued treatment with these agent(s) greater than or equal to 2 weeks prior to enrollment.
- A history of any other primary malignancy that has not been treated with curative intent and that has not been in complete remission for at least 2 years (exempt from the two year limit are non-melanoma skin cancer and cervical carcinoma in-situ on biopsy or a squamous intraepithelial lesion on PAP smear).
- Active infection.
- Any significant medical illnesses or toxicities that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the subjects' ability to tolerate this therapy. Subjects must not have any disease that will obscure toxicity or dangerously alter drug metabolism, e.g. congestive heart failure, moderate to severe liver and renal disease, other cancers.
- Cardiac ejection fraction (LVEF) by multiple gated acquisition scan (MUGA) less than the institutional lower limit of normal.
- Prior investigational therapy within the past 28 days.
- Prior AQ4N therapy.
- Hypersensitivity to AQ4N or to any ingredients contained in the drug formulation.
- Hypersensitivity to temozolomide or to any ingredients contained in the drug formulation and dacarbazine (DTIC).
- Pregnant or lactating women.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394628
|United States, California|
|University of California, Los Angeles||Recruiting|
|Los Angeles, California, United States|
|Contact: Emese Filka 310-794-3521|
|Principal Investigator: Tim Clughsey, MD|
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|Northwestern University Feinberg School of Medicine||Recruiting|
|Chicago, Illinois, United States, 60611|
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|Henry Ford Health Systems||Recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Ruth Ann Beasse 313-916-3731 firstname.lastname@example.org|
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|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Velmeca McCrea 919-684-5632 email@example.com|
|Principal Investigator: David Reardon, MD|
|United States, Texas|
|Baylor Research Institute||Recruiting|
|Dallas, Texas, United States|
|Contact: Stephanie Peschka, RN 214-820-8685|
|Principal Investigator: Karen Fink, MD|
|Other Study ID Numbers:||
|First Posted:||November 1, 2006 Key Record Dates|
|Last Update Posted:||May 30, 2007|
|Last Verified:||May 2007|
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