Glioblastoma MultiformePhase 1/2NCT00394628
AQ4N in Combination With Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma Multiforme
A Phase 1/2 study testing AQ4N, Temozolomide and Radiotherapy in people with Glioblastoma Multiforme, run by Novacea at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- AQ4N, Temozolomide and Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2006to not given
- Phase
- Phase 1/2
- 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
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Lilia Gallot, 312-695-1363
Jeffrey Raizer, MD
- Recruiting
Baylor Research Institute
Dallas, Texas
Stephanie Peschka, RN, 214-820-8685
Karen Fink, MD
- Recruiting
Henry Ford Health Systems
Detroit, Michigan, 48202
Ruth Ann Beasse, 313-916-3731, rbeasse1@hfhs.org
Tom Mikkelsen, MD
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Velmeca McCrea, 919-684-5632, velmeca.mccrea@duke.edu
David Reardon, MD
- Recruiting
University of California, Los Angeles
Los Angeles, California
Emese Filka, 310-794-3521
Tim Clughsey, MD
About this study
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
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.
- Conditions
- Glioblastoma Multiforme
- Being tested
- AQ4N, Temozolomide, Radiotherapy
- Keywords
- Glioblastoma Multiforme, Radiotherapy, temozolomide, adjuvant temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQ4NDrug
TemozolomideDrug
RadiotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novacea
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394628
- Sponsor's protocol ID
- 021-003
- Status last verified
- May 2007
- First submitted
- 31 Oct 2006
- Last updated
- 30 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00394628
- Acronym / sponsor ID
- 021-003
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma Multiforme, Radiotherapy, temozolomide, adjuvant temozolomide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NovaceaIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- First posted
- 1 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AQ4N | Drug | – |
| Temozolomide | Drug | – |
| Radiotherapy | Procedure or surgery | – |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AQ4N, Temozolomide and Radiotherapy in people with Glioblastoma Multiforme, run by Novacea at 5 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 9 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: status not confirmed, as of the sponsor's last update on 30 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2007.