Brain and Central Nervous System TumorsPhase 1/2NCT00124657
Erlotinib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Glioma
A Phase 1/2 study testing Erlotinib hydrochloride in people with Brain and Central Nervous System Tumors, run by St. Jude Children's Research Hospital at 3 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It may also make tumor cells more sensitive to radiation therapy. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- Erlotinib hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2005to Sep 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Diagnosis of high-grade glioma of 1 of the following types:
- Unfavorable low-grade glioma
- Gliomatosis cerebri or bithalamic involvement
- Histologically confirmed high-grade glioma (WHO grade III or IV) of 1 of the following subtypes:
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic oligoastrocytoma
- Anaplastic ganglioglioma
- Pleomorphic xanthoastrocytoma with anaplastic features
- Malignant glioneuronal tumor
- Glioblastoma multiforme
- Gliosarcoma
- Newly diagnosed disease
- Intracranial or spinal cord tumors allowed
PATIENT CHARACTERISTICS:
Age
- 3 to 21
Performance status
- Karnofsky 40-100% (age 17 to 21 years) OR
- Lansky 40-100% (age 3 to 16 years)
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3 (transfusion independent)
- Hemoglobin ≥ 8 g/dL (transfusion allowed)
Hepatic
- Bilirubin < 1.5 times upper limit of normal (ULN)
- SGPT < 5 times ULN
- Albumin ≥ 2 g/dL
Renal
- Creatinine < 2 times normal OR
- Glomerular filtration rate > 70 mL/min
Cardiovascular
- No significant cardiovascular problem
Pulmonary
- No significant pulmonary problem
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No uncontrolled infection
- No significant medical illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior or concurrent biologic agents
Chemotherapy
- No prior or concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy
Surgery
- No more than 42 days since prior surgery
Other
- No other prior or concurrent anticancer or experimental treatment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke Children's Hospital and Health Center
Durham, North Carolina, 27710
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of California San Diego
San Diego, California, 92123-4282
About this study
Official title: A Phase I/II Trial of a New Tyrosine Kinase Inhibitor (Tarceva; Erlotinib Hydrochloride; OSI-774) During and After Radiotherapy in the Treatment of Patients With Newly Diagnosed High Grade Glioma and Unfavorable Low-Grade Glioma
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with erlotinib may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with radiation therapy and to see how well they work in treating young patients with newly diagnosed glioma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicity of erlotinib when administered during and after radiotherapy in young patients with newly diagnosed high-grade glioma and unfavorable low-grade glioma.
- Determine the 1- and 2-year progression-free survival of patients treated with this regimen.
Secondary
- Determine the toxic effects of this regimen in these patients.
- Correlate genetic abnormalities in epidermal growth factor receptor (EGFR) and components of downstream pathways with treatment response in patients treated with this regimen.
- Determine the ability of erlotinib to inhibit EGFR signaling in patients with high-grade glioma who require second surgery.
- Determine the pharmacokinetics of erlotinib and its metabolites in these patients.
- Correlate plasma and cerebrospinal fluid levels of vascular endothelial growth factor and basic fibroblast growth factor with tumor response in patients treated with this regimen.
- Correlate irradiation dosimetry with patterns of failure, standard and investigational imaging, and toxicity in patients treated with this regimen.
OUTLINE: This is a phase I dose-escalation study of erlotinib followed by a phase II study.
- Phase I: Patients undergo radiotherapy once daily, 5 days week, for approximately 6½ weeks. Beginning on the first day of radiotherapy, patients receive oral erlotinib once daily for up to 2 years.
Cohorts of patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
- Phase II: Patients will receive erlotinib as in phase I at the MTD and undergo radiotherapy as in phase I.
PROJECTED ACCRUAL: A total of 75-80 patients (15-20 for the phase I portion and 60 for the phase II portion) will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- Erlotinib hydrochloride
- Keywords
- adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma, adult mixed glioma, childhood mixed glioma, untreated childhood cerebellar astrocytoma, childhood high-grade cerebral astrocytoma, childhood low-grade cerebral astrocytoma, childhood oligodendroglioma, childhood spinal cord neoplasm
- Medical subject headings
- Central Nervous System Neoplasms, Astrocytoma, Oligodendroglioma, Glioblastoma, Gliosarcoma, Glioma, Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib hydrochlorideDrug
Also called Tarceva, OSI-774, NSC#718781
This study has 2 components: a Phase I component which estimated the MTD and DLT(s) of erlotinib given once a day during and after conventionally fractionated RT for a period of 8 weeks (DLT-evaluation period), followed by continuous administration of this medication for up to 3 years; and a Phase II component where erlotinib will be given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study is 120mg/m2 per day (maximum dose of 200mg per day).
| Study group | Role | What they receive |
|---|---|---|
| Patients with High-Grade/Low-Grade Glioma | Experimental | Patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) are not eligible for this study. Patients with spinal cord tumors will be eligible for the Phase I and Phase II component of this study, but they will not be taken into consideration to estimate PFS in the Phase II component of this trial because of their notoriously worse prognosis. Patients receive erlotinib hydrochloride. Receives: Drug: Erlotinib hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-limiting Toxicity (DLT)
DLT was defined as any of the following toxicities attributable to erlotinib therapy: thrombocytopenia grade 3 and 4; neutropenia grade 4; or any grade 3 and 4 non-hematologic toxicity except for grade 3 diarrhea and grade 3 nausea and vomiting lasting ≤48 hours in participants not receiving optimal supportive therapy, grade 3 skin rash, which did not affect normal daily activities, grade 3 fever or nonneutropenic infection, grade 3 seizures, grade 3 weight gain or loss, and grade 3 transaminase elevation that returned to grade 1 or baseline within 7 days. After enrollment of the first 4 participants, grade 3 and 4 electrolyte abnormalities that resolved to ≤grade 2 within 7 days were excluded as DLT. Toxicities were graded according to the Common Terminology Criteria for Adverse Events version 3.0.
Measured: During the first 8 weeks of therapy
Maximum Tolerated Dose (MTD) of Erlotinib
MTD was defined as the highest dosage level in which no more than one of six assessable participants experienced dose-limiting toxicities (DLT). The dosage of erlotinib was increased by approximately 30% in each dosage level starting at 80% of the MTD in adults with solid tumors. A traditional 3+3 dose escalation scheme was used to estimate the MTD.
Measured: During the first 8 weeks of therapy.
Progression Free Survival (PFS)
Progression-free survival (PFS) distributions for the Phase II participants with anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM) were calculated using Kaplan-Meier estimates (n=41). PFS was defined as the interval between treatment start and initial failure, including clinical or radiologic progression or death from any cause.
PFS was not calculated for the other disease types.
Measured: 1 and 2 years after end of therapy
Secondary outcomes (9)
Cmax of Erlotinib and Its Metabolite OSI-420
Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.
Measured: After first dose of therapy, and Day 8 of therapy
Erlotinib Tmax
Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.
Measured: After first dose of therapy
AUC Time 0-infinite (AUCinf) of Erlotinib and Its Metabolite OSI-420
Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.
Measured: After first dose of therapy, and Day 8 of therapy
Number of Positive Mutations of EGFR and Downstream Pathways
Statistical analyses of genomic changes, expression profiles and validation studies should be considered in an exploratory and hypothesis-generating context.
Fresh frozen tumor tissue was obtained at the time of tumor resection and diagnosis. DNA was extracted from formalin-fixed, paraffin-embedded tissue. The entire PTEN coding sequence (exons 1-9), exons 1, 9 and 20 of PIK3CA, and exons 17-24 of EGFR were evaluated using exon-specific PCR amplification, and immunohistochemistry was done. Tumor lesions were considered positive if >25% cells were immunoreactive.
Measured: Once at tumor resection and diagnosis
Ability of Erlotinib to Inhibit EGFR Signaling
The objective was to test the ability of erlotinib to inhibit the EGFR signaling in patients with high-grade glioma who required a second surgery.
This outcome was not assessed due to insufficient availability of tumor and control samples for analysis.
Measured: 5 Years
Correlation Between Standard Magnetic Resonance Imaging and Investigational Radiologic Techniques in Assessing Tumor Response to This Treatment
This objective was to prospectively investigate the correlation between standard magnetic resonance imaging (MRI) and investigational radiologic techniques (MR spectroscopy, perfusion/diffusion, PET scan, DEMRI/BLAST) in assessing tumor response to this treatment.
Measured: at diagnosis and regular intervals during therapy (up to 2 years after start of therapy)
To Prospectively Investigate the Technical Factors Involved in Planning and Administering Conformal Fractionated RT as Outlined in This Study, and to Correlate RT Dosimetry With Patterns of Failure, Standard and Investigational Imaging and Toxicity
Measured: 5 Years
Plasma and CSF Levels of VEGF, bFGF, and SDF1
This objective was to determine the plasma and CSF levels of the VEGF, bFGF, and SDF1 at diagnosis, and the plasma levels of these factors at regular intervals during therapy, and to analyze the association of these results with tumor response.
Measured: at diagnosis and regular intervals during therapy (up to 2 years after start of therapy)
Number of Participants Experiencing Grade 3 or 4 Toxicity Events
Adverse events were collected systematically for each of the 44 Phase II participants from the time of enrollment to the completion of therapy (approximately 2 years from start of therapy).
Measured: From start of therapy through 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startMar 2005
- Primary completionJul 2012
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rady Children's Hospital, San Diego, Duke University
- Responsible party
- Sponsor
- Investigators
- Alberto Broniscer, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124657
- Sponsor's protocol ID
- SJHG04
- Status last verified
- Oct 2015
- First submitted
- 26 Jul 2005
- Last updated
- 4 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of a New Tyrosine Kinase Inhibitor (Tarceva; Erlotinib Hydrochloride; OSI-774) During and After Radiotherapy in the Treatment of Patients With Newly Diagnosed High Grade Glioma and Unfavorable Low-Grade Glioma
- ClinicalTrials.gov ID
- NCT00124657
- Acronym / sponsor ID
- SJHG04
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma, adult mixed glioma, childhood mixed glioma, untreated childhood cerebellar astrocytoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- Rady Children's Hospital, San Diego, Duke University
- Study start
- Mar 2005
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 28 Jul 2005 (estimated)
- Results
- Posted 29 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with erlotinib may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with radiation therapy and to see how well they work in treating young patients with newly diagnosed glioma.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicity of erlotinib when administered during and after radiotherapy in young patients with newly diagnosed high-grade glioma and unfavorable low-grade glioma.
- Determine the 1- and 2-year progression-free survival of patients treated with this regimen.
Secondary
- Determine the toxic effects of this regimen in these patients.
- Correlate genetic abnormalities in epidermal growth factor receptor (EGFR) and components of downstream pathways with treatment response in patients treated with this regimen.
- Determine the ability of erlotinib to inhibit EGFR signaling in patients with high-grade glioma who require second surgery.
- Determine the pharmacokinetics of erlotinib and its metabolites in these patients.
- Correlate plasma and cerebrospinal fluid levels of vascular endothelial growth factor and basic fibroblast growth factor with tumor response in patients treated with this regimen.
- Correlate irradiation dosimetry with patterns of failure, standard and investigational imaging, and toxicity in patients treated with this regimen.
OUTLINE: This is a phase I dose-escalation study of erlotinib followed by a phase II study.
- Phase I: Patients undergo radiotherapy once daily, 5 days week, for approximately 6½ weeks. Beginning on the first day of radiotherapy, patients receive oral erlotinib once daily for up to 2 years.
Cohorts of patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
- Phase II: Patients will receive erlotinib as in phase I at the MTD and undergo radiotherapy as in phase I.
PROJECTED ACCRUAL: A total of 75-80 patients (15-20 for the phase I portion and 60 for the phase II portion) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with High-Grade/Low-Grade Glioma | Experimental | Drug: Erlotinib hydrochloridePatients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) are not eligible for this study. Patients with spinal cord tumors will be eligible for the Phase I and Phase II component of this study, but they will not be taken into consideration to estimate PFS in the Phase II component of this trial because of their notoriously worse prognosis. Patients receive erlotinib hydrochloride. |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 hydrochlorideAlso: Tarceva, OSI-774, NSC#718781This study has 2 components: a Phase I component which estimated the MTD and DLT(s) of erlotinib given once a day during and after conventionally fractionated RT for a period of 8 weeks (DLT-evaluation period), followed by continuous administration of this medication for up to 3 years; and a Phase II component where erlotinib will be given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study is 120mg/m2 per day (maximum dose of 200mg per day). | Drug | Patients with High-Grade/Low-Grade Glioma |
Primary outcome
Number of Participants With Dose-limiting Toxicity (DLT)
Time frame: During the first 8 weeks of therapy
DLT was defined as any of the following toxicities attributable to erlotinib therapy: thrombocytopenia grade 3 and 4; neutropenia grade 4; or any grade 3 and 4 non-hematologic toxicity except for grade 3 diarrhea and grade 3 nausea and vomiting lasting ≤48 hours in participants not receiving optimal supportive therapy, grade 3 skin rash, which did not affect normal daily activities, grade 3 fever or nonneutropenic infection, grade 3 seizures, grade 3 weight gain or loss, and grade 3 transaminase elevation that returned to grade 1 or baseline within 7 days. After enrollment of the first 4 participants, grade 3 and 4 electrolyte abnormalities that resolved to ≤grade 2 within 7 days were excluded as DLT. Toxicities were graded according to the Common Terminology Criteria for Adverse Events version 3.0.
Maximum Tolerated Dose (MTD) of Erlotinib
Time frame: During the first 8 weeks of therapy.
MTD was defined as the highest dosage level in which no more than one of six assessable participants experienced dose-limiting toxicities (DLT). The dosage of erlotinib was increased by approximately 30% in each dosage level starting at 80% of the MTD in adults with solid tumors. A traditional 3+3 dose escalation scheme was used to estimate the MTD.
Progression Free Survival (PFS)
Time frame: 1 and 2 years after end of therapy
Progression-free survival (PFS) distributions for the Phase II participants with anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM) were calculated using Kaplan-Meier estimates (n=41). PFS was defined as the interval between treatment start and initial failure, including clinical or radiologic progression or death from any cause. PFS was not calculated for the other disease types.
9 secondary outcomes
Cmax of Erlotinib and Its Metabolite OSI-420
Time frame: After first dose of therapy, and Day 8 of therapy
Erlotinib Tmax
Time frame: After first dose of therapy
AUC Time 0-infinite (AUCinf) of Erlotinib and Its Metabolite OSI-420
Time frame: After first dose of therapy, and Day 8 of therapy
Number of Positive Mutations of EGFR and Downstream Pathways
Time frame: Once at tumor resection and diagnosis
Ability of Erlotinib to Inhibit EGFR Signaling
Time frame: 5 Years
Correlation Between Standard Magnetic Resonance Imaging and Investigational Radiologic Techniques in Assessing Tumor Response to This Treatment
Time frame: at diagnosis and regular intervals during therapy (up to 2 years after start of therapy)
To Prospectively Investigate the Technical Factors Involved in Planning and Administering Conformal Fractionated RT as Outlined in This Study, and to Correlate RT Dosimetry With Patterns of Failure, Standard and Investigational Imaging and Toxicity
Time frame: 5 Years
Plasma and CSF Levels of VEGF, bFGF, and SDF1
Time frame: at diagnosis and regular intervals during therapy (up to 2 years after start of therapy)
Number of Participants Experiencing Grade 3 or 4 Toxicity Events
Time frame: From start of therapy through 2 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink 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.
Alberto Broniscer, MD principal investigator
St. Jude Children's Research Hospital
3 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 Erlotinib hydrochloride in people with Brain and Central Nervous System Tumors, run by St. Jude Children's Research Hospital at 3 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?
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 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 29 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Dose-limiting Toxicity (DLT) (time frame: During the first 8 weeks of therapy). The study lists 3 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 4 Dec 2015.