GlioblastomaPhase 1NCT00609999
Ph I Dasatinib + Erlotinib in Recurrent MG
A Phase 1 study testing Erlotinib and Dasatinib in people with Glioblastoma and Gliosarcoma, run by Duke University at 1 site in United States.
Trial summary
Primary: To determine maximum tolerated dose \& dose limiting toxicity of dasatinib when combined w erlotinib among pts w recurrent MG Secondary: To further evaluate safety \& tolerability of dasatinib + erlotinib To evaluate pharmacokinetics of dasatinib when administered w erlotinib among recurrent MG pts who are on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Gliosarcoma
- What is being tested?
- Erlotinib and Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jul 2010
- 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
- Diagnosis of recurrent/progressive WHO grade IV MG or WHO grade III MG. Pts with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO grade III / IV MG
- >18 yrs
- Karnofsky Performance Status >70 percent
- Pts presenting in 1st, 2nd / 3rd relapse. Prior therapy must have included external beam XRT
- Adequate bone marrow, liver \& renal function as assessed by following:
- Hemoglobin>9.0g/dl
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- ANC>1,500/mm3
- Platelet count>100,000/mm3
- Total bilirubin<1.5 x ULN
- ALT \& AST<2.5 x ULN
- INR<1.5 or PT/PTT within normal limits. Pts receiving anti-coagulation treatment w low-molecular weight heparin allowed to participate, oral warfarin is not permitted
- Creatinine<1.5 x ULN
- Serum Na, K+, Mg2+, Phosphate \& Ca2+ >LLN
- Interval<2 wks between prior surgical resection \& initiation of study regimen
- Interval <12 weeks from completion of standard, daily XRT, unless one of following occurs: new area of enhancement on MRI imaging that is outside XRT field; biopsy proven recurrent tumor; / radiographic evidence of progressive tumor on 2 consecutive scans >4 wks apart.
- Interval <4weeks from prior chemotherapy unless there is unequivocal evidence of tumor progression \& pt has recovered from all anticipated toxicities from prior therapy
- Interval <4weeks from prior investigational agent unless there is unequivocal evidence of tumor progression \& pt has recovered from all anticipated toxicities from prior therapy
- Signed written informed consent including HIPAA according to institutional guidelines. Signed informed consent must be obtained prior to any study specific procedures
- If sexually active, pts will take contraceptive measures for duration of treatments \& for 4 weeks following discontinuation of dasatinib \& Erlotinib.
- Women of childbearing potential must have negative serum or urine pregnancy test within 72 hrs prior to start of study drug administration
Who cannot join
- No prior dasatinib / oral EGFR-inhibitor therapy
- Pregnancy/breast feeding
- History of significant concurrent illness
- ->3 prior episodes of progressive disease
- Significant cardiac disease
- Excessive risk of bleeding as defined by stroke <6 months, history of CNS / intraocular bleed,/ septic endocarditis.
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- Concurrent severe and/or uncontrolled medical disease that could compromise participation in study including any of following: pleural / pericardial effusion of any grade; uncontrolled diabetes; uncontrolled hypertension; active clinically serious infection >CTCAEv3 Gr2 requiring active intervention; history of clinically-significant bleeding diathesis or coagulopathy including platelet function disorder or acquired bleeding disorder within 1yr; impairment of GI function /GI disease that may significantly alter absorption of study regimen; ongoing or recent significant gastrointestinal bleeding
- Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks <6 months
- Any hemorrhage/bleeding event >CTCAEv3AE Gr3 within 4wks of 1st dose of study drug
- Serious non-healing wound, ulcer, /bone fracture
- Major surgery, open biopsy /significant traumatic injury <4 weeks of 1st study drug
- Known HIV infection/chronic Hepatitis B/C
- Pt is <3yrs free of another primary malignancy except: if other primary malignancy is either not currently clinically significant/does not require active intervention. Existence of any other malignant disease is not allowed.
- Pts unwilling to/unable to comply with protocol including ability to swallow whole pills/presence of any malabsorption syndrome
- Concurrent administration of warfarin, rifampin/St. John's Wort
- Subjects w hypokalemia/hypomagnesemia if it cannot be corrected
- Prisoners/subjects who are compulsorily detained for treatment of either psychiatric/physical illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Phase I Study of Dasatinib Plus Erlotinib in Recurrent Malignant Glioma
Primary:
To determine maximum tolerated dose \& dose limiting toxicity of dasatinib when combined w erlotinib among pts w recurrent MG
Secondary:
To further evaluate safety \& tolerability of dasatinib + erlotinib To evaluate pharmacokinetics of dasatinib when administered w erlotinib among recurrent MG pts who are on \& not on CYP-3A enzyme inducing anti-epileptic drugs To evaluate for anti-tumor activity with this regimen in this patient population
Read the detailed description
Tarceva administered on continuous oral dosing schedule at 150 mg/day for pts not on EIAEDs \& 450 mg/day for pts on EIAEDs. Starting dose level of dasatinib will be 100 mg once day via continuous oral daily dosing. Dasatinib will be increased in successive cohorts of enrolled pts. Pts will remain on treatment until excessive toxicity, progressive disease, withdrawal of consent/death.
Pts have confirmed diagnosis of recurrent/progressive WHO gr IV MG / WHO grade III MG. Phase I 3+3 dose escalation design w 2 independently escalated stratum: stratum A-pts not on CYP3A-enzyme inducing anti-epileptic drugs; stratum B-pts on EIAEDs. Assessment of safety will be based mainly on frequency of adverse events, particularly adverse events leading to discontinuation of treatment \& on number of significant lab abnormalities.
- Conditions
- Glioblastoma, Gliosarcoma
- Being tested
- Erlotinib and Dasatinib
- Keywords
- Glioblastoma, Gliosarcoma, GBM, Recurrent MG, Erlotinib, Dasatinib, Brain tumor, Malignant glioma, Tarceva, Sprycel
- Medical subject headings
- Glioblastoma, Gliosarcoma, Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib and DasatinibDrug
Also called Dasatinib, Erlotinib, Tarceva, Sprycel
You will begin study drug regimen on day 1 of cycle 1 w Dasatinib. If you are undergoing Dasatinib pharmacokinetic blood analysis, Dasatinib will be taken alone until initial PK assessments are collected. Erlotinib will be begin after initial Dasatinib PK assessments are collected \& will continue to be administered w Dasatinib on continuous daily dosing schedule. Initial Dasatinib PK assessments will be collected over 24hrs between days 3-7 of cycle 1 \& at end of cycle 1. If you are not undergoing Dasatinib PK collections you will begin both Dasatinib \& Erlotinib together on day 1 of cycle 1. Both drugs will be given in continuous daily oral manner. Cycle is defined as Dasatinib \& Erlotinib given daily for 28 days for purpose of scheduling evaluations.
| Study group | Role | What they receive |
|---|---|---|
| Stratum A | Experimental | Pts not on EIAEDs Receives: Drug: Erlotinib and Dasatinib |
| Stratum B | Experimental | Pts on EIAEDs Receives: Drug: Erlotinib and Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine MTD & DLT of Dasatinib when combined w Erlotinib among pts w Recurrent MG
Measured: 12 months
Secondary outcomes (3)
To further evaluate safety & tolerability of Dasatinib + Erlotinib
Measured: 12 months
To evaluate the PK of Dasatinib when administered w Erlotinib among Recurrent MG pts who are on & not on EIAEDs
Measured: 12 months
To evaluate for anti-tumor activity w this regimen in this pt population
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Annick Desjardins, MD, FRCPC, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609999
- Sponsor's protocol ID
- Pro00002272
- Status last verified
- Apr 2012
- First submitted
- 25 Jan 2008
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Dasatinib Plus Erlotinib in Recurrent Malignant Glioma
- ClinicalTrials.gov ID
- NCT00609999
- Acronym / sponsor ID
- Pro00002272
- Conditions
- Glioblastoma, Gliosarcoma
- Keywords
- Glioblastoma, Gliosarcoma, GBM, Recurrent MG, Erlotinib, Dasatinib, Brain tumor, Malignant glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Genentech, Inc.
- Study start
- Jan 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Feb 2008 (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.
Primary:
To determine maximum tolerated dose \& dose limiting toxicity of dasatinib when combined w erlotinib among pts w recurrent MG
Secondary:
To further evaluate safety \& tolerability of dasatinib + erlotinib To evaluate pharmacokinetics of dasatinib when administered w erlotinib among recurrent MG pts who are on \& not on CYP-3A enzyme inducing anti-epileptic drugs To evaluate for anti-tumor activity with this regimen in this patient population
Detailed description
Tarceva administered on continuous oral dosing schedule at 150 mg/day for pts not on EIAEDs \& 450 mg/day for pts on EIAEDs. Starting dose level of dasatinib will be 100 mg once day via continuous oral daily dosing. Dasatinib will be increased in successive cohorts of enrolled pts. Pts will remain on treatment until excessive toxicity, progressive disease, withdrawal of consent/death.
Pts have confirmed diagnosis of recurrent/progressive WHO gr IV MG / WHO grade III MG. Phase I 3+3 dose escalation design w 2 independently escalated stratum: stratum A-pts not on CYP3A-enzyme inducing anti-epileptic drugs; stratum B-pts on EIAEDs. Assessment of safety will be based mainly on frequency of adverse events, particularly adverse events leading to discontinuation of treatment \& on number of significant lab abnormalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratum A | Experimental | Drug: Erlotinib and DasatinibPts not on EIAEDs |
| Stratum B | Experimental | Drug: Erlotinib and DasatinibPts on EIAEDs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Diagnosis of recurrent/progressive WHO grade IV MG or WHO grade III MG. Pts with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO grade III / IV MG
- >18 yrs
- Karnofsky Performance Status >70 percent
- Pts presenting in 1st, 2nd / 3rd relapse. Prior therapy must have included external beam XRT
- Adequate bone marrow, liver \& renal function as assessed by following:
Key exclusion criteria (17 listed)
- No prior dasatinib / oral EGFR-inhibitor therapy
- Pregnancy/breast feeding
- History of significant concurrent illness
- ->3 prior episodes of progressive disease
- Significant cardiac disease
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 |
|---|---|---|
| Erlotinib and DasatinibAlso: Dasatinib, Erlotinib, Tarceva, SprycelYou will begin study drug regimen on day 1 of cycle 1 w Dasatinib. If you are undergoing Dasatinib pharmacokinetic blood analysis, Dasatinib will be taken alone until initial PK assessments are collected. Erlotinib will be begin after initial Dasatinib PK assessments are collected \& will continue to be administered w Dasatinib on continuous daily dosing schedule. Initial Dasatinib PK assessments will be collected over 24hrs between days 3-7 of cycle 1 \& at end of cycle 1. If you are not undergoing Dasatinib PK collections you will begin both Dasatinib \& Erlotinib together on day 1 of cycle 1. Both drugs will be given in continuous daily oral manner. Cycle is defined as Dasatinib \& Erlotinib given daily for 28 days for purpose of scheduling evaluations. | Drug | Stratum A, Stratum B |
Primary outcome
To determine MTD & DLT of Dasatinib when combined w Erlotinib among pts w Recurrent MG
Time frame: 12 months
3 secondary outcomes
To further evaluate safety & tolerability of Dasatinib + Erlotinib
Time frame: 12 months
To evaluate the PK of Dasatinib when administered w Erlotinib among Recurrent MG pts who are on & not on EIAEDs
Time frame: 12 months
To evaluate for anti-tumor activity w this regimen in this pt population
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- The Preston Robert Tisch Brain Tumor Center at DUKELink provided by the sponsor.
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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.
Annick Desjardins, MD, FRCPC principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erlotinib and Dasatinib in people with Glioblastoma and Gliosarcoma, run by Duke University at 1 site 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 20 inclusion and 17 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 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To determine MTD & DLT of Dasatinib when combined w Erlotinib among pts w Recurrent MG (time frame: 12 months). 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 16 Jul 2014; AzTrials last refreshed its copy on 6 Nov 2026.