GliomaPhase 2NCT02781792
Temozolomide Chronotherapy for High Grade Glioma
A Phase 2 study testing Temozolomide, Functional Assessment of Cancer Therapy - Brain and ActTrust Condor Instrument Watch in people with Glioma and Glioblastoma Multiforme, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Temozolomide (TMZ) is the chemotherapy drug approved by the FDA to increase survival in glioblastoma (GBM) patients beyond surgical resection and radiation therapy alone. Give its activity in astrocytomas, TMZ is commonly used in grade III anaplastic astrocytoma (AA) as well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioblastoma Multiforme
- What is being tested?
- Temozolomide, Functional Assessment of Cancer Therapy - Brain and ActTrust Condor Instrument Watch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2016to 18 Jul 2024
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed and recurrent high grade gliomas (WHO grades III \& IV) and high risk WHO grade II gliomas who are to begin treatment with monthly high dose temozolomide therapy.
- Scheduled to receive adjuvant temozolomide therapy after having completed concurrent temozolomide and radiation therapy.
- At least 18 years of age.
- Karnofsky performance status ≥ 60%
- Ability to understand and willingness to sign an IRB approved written informed consent document
Who cannot join
- -Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Randomized Feasibility Study Evaluating Temozolomide Chronotherapy for High Grade Glioma
Temozolomide (TMZ) is the chemotherapy drug approved by the FDA to increase survival in glioblastoma (GBM) patients beyond surgical resection and radiation therapy alone. Give its activity in astrocytomas, TMZ is commonly used in grade III anaplastic astrocytoma (AA) as well. Both grade III AA and grade IV GBM are high grade gliomas (HGG). The short half-life of this drug and known oscillations in DNA damage repair make it an ideal candidate for chronotherapy.
Chronotherapy is the improvement of treatment outcomes by minimizing treatment toxicity and maximizing efficacy through delivery of a medication according to the timing of biological rhythms within a patient. Chronotherapy has improved outcomes through the reduction of side effects and increase in anti-tumor activity for a variety of cancers, but has never been applied to the treatment of gliomas.
Based on the preliminary preclinical data for chronotherapeutic TMZ treatment of intracranial glioma xenografts and the success of chronotherapy in the treatment of other cancers, the investigators hypothesize that the timing of TMZ treatment will alter its efficacy and toxicity.
- Conditions
- Glioma, Glioblastoma Multiforme
- Being tested
- Temozolomide, Functional Assessment of Cancer Therapy - Brain, ActTrust Condor Instrument Watch
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodar
-Given standard of care
Functional Assessment of Cancer Therapy - BrainOther
Also called FACT-Br
- 23-item questionnaire that can be completed in 5 to 10 minutes with little or no assistance in patients who are not neurologically incapacitated. This brain subscale is usually used along with the core (general) questionnaire [2] that includes 27 items.
- Patients rate all 5 items using a five-point Likert scale ranging from 0 "not at all" to 4 "very much." Overall, higher ratings suggest higher QOL. Items are totaled to produce the following subscales, along with an overall QOL score: physical well-being (7 items); social/family well-being (7 items); emotional well-being (6 items); functional well-being (7 items); and concerns relevant to patients with brain tumors (23 items)
- The sleep portion of this questionnaire consists of 17 questions about sleeping patterns and the ability to rate severity of insomnia.
ActTrust Condor Instrument WatchOther
-Will be required to wear 24 hours per day and will only be removed at specified data collection time points
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Temozolomide morning | Experimental | * Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).
* FACT-Br quality of life at baseline, at the beginning of each cycle of chemotherapy, and 1 month after the final chemotherapy treatment Receives: Drug: Temozolomide; Other: Functional Assessment of Cancer Therapy - Brain; Other: ActTrust Condor Instrument Watch |
| Arm 2: Temozolomide evening | Experimental | * Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).
* FACT-Br quality of life at baseline, at the beginning of each cycle of chemotherapy, and 1 month after the final chemotherapy treatment Receives: Drug: Temozolomide; Other: Functional Assessment of Cancer Therapy - Brain; Other: ActTrust Condor Instrument Watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time
Compliance is defined as no more than one of five doses of temozolomide per cycle taken outside of the assigned administration time.
Measured: Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)
Duration of Response
- Response and progression will be evaluated in this study using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline [JCO 28(11): 1963-1972, 2010].
- The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Measured: Through completion of follow-up (estimated to be 30 months)
Secondary outcomes (11)
Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws
- Lymphopenia grade 3 is <500-200/mm^3 and grade 4 is <200/mm^3
- Leukopenia grade 3 is <2000-1000/mm^3 and grade 4 is <1000/mm^3
- Neutropenia grade 3 is <1000-500/mm^3 and grade 4 is <500/mm^3
- Thrombocytopenia grade 3 is <50,000-25,000/mm^3 and grade 4 is <25,000/mm^3
- Anemia grade 3 is <8.0-6.5 g/dL and grade 4 is <6.5 g/dL
Measured: Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)
Change in Quality of Life as Measured by FACT-Br Score - Physical Well-being Score
7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range is 0-28. A higher score indicates a lower physical well-being quality of life.
Measured: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Change in Quality of Life as Measured by FACT-Br Score - Social/Family Well-being Score
7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-28. A higher score indicates a higher social/family well-being quality of life.
Measured: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Change in Quality of Life as Measured by FACT-Br Score - Emotional Well-being Score
6-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-24. A higher score indicates a lower emotional well-being quality of life.
Measured: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Change in Quality of Life as Measured by FACT-Br Score - Functional Well-being Score
7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-28. A higher score indicates a higher emotional well-being quality of life.
Measured: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Median Progression-free Survival (PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Measured: Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days)
Median Overall Survival
Measured: Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days)
Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening
Sleep Questionnaire - 1 yes/no question of "do you have problems getting to sleep or staying asleep?"
Measured: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening
- Sleep Questionnaire:
- Difficulty falling asleep/difficulty staying asleep/problem waking up too early: Answers range from 0=none, mild=1, moderate=2, severe=3, very=4.
- How satisfied or dissatisfied are you with your current sleeping pattern question: Answers range from 0=very satisfied to 4=very dissatisfied.
- To what extent do you consider your sleep problem to interfere with your daily functioning question: Answers range from 0=not at all interfering, 1=a little, 2=somewhat, 3=much, 4=very much interfering.
- How noticeable to others do you think your sleep problem is in terms of impairing the quality of your life question: Answers range from 0=not at all noticeable, 1=barely, 2 = somewhat, 3 =much, 4=very noticeable.
- How worried or distressed are you about your current sleep problem question: Answers range from 0=not at all=0, 1=a little, 2=somewhat, 3=much, 4=very much.
Measured: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Mean Circadian Amplitude
- The ActTrust Condor Instrument watches are wrist actimetry/accelerometers. Patients will wear an accelerometer on their wrist to measure activity level during the day and at night until two months after the end of treatment.
- Circadian amplitude, refers to the difference between the highest and lowest points of a circadian rhythm over a 24-hour cycle, is typically measured in the units of the rhythm being quantified.
- The circadian mean amplitude was calculated per day for each patient with the mean and standard deviation reported across all days for each individual patient.
Measured: From start of treatment through 2 months after end of treatment (median length 100 days, full range 78-240 days)
Mean Sleep Regularity Index (SRI)
- The ActTrust Condor Instrument watches are wrist actimetry/accelerometers. Patients will wear an accelerometer on their wrist to measure activity level during the day and at night until two months after the end of treatment.
- Sleep regularity index (SRI) is the probability of being at rest, calculated per day for each patient. An SRI closer to 0 indicates irregular sleep patterns (i.e., more variable day to day), while values closer to 1 indicate regular sleep patterns. The SRI index scale is 0~1.
- The SRI was calculated per day for each patient with the mean and standard deviation reported across all days for each individual patient.
Measured: From start of treatment through 2 months after end of treatment (median length 100 days, full range 78-240 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study start11 Aug 2016
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milan Chheda, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781792
- Sponsor's protocol ID
- 201605081
- Status last verified
- Jun 2025
- First submitted
- 20 May 2016
- Last updated
- 27 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Damato AR, Katumba RGN, Luo J, Atluri H, Talcott GR, Govindan A, Slat EA, Weilbaecher KN, Tao Y, Huang J, Butt OH, Ansstas G, Johanns TM, Chheda MG, Herzog ED, Rubin JB, Campian JL. A randomized feasibility study evaluating temozolomide circadian medicine in patients with glioma. Neurooncol Pract. 2022 Jan 31;9(3):193-200. doi: 10.1093/nop/npac003. eCollection 2022 May.
PubMed 35601970
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Feasibility Study Evaluating Temozolomide Chronotherapy for High Grade Glioma
- ClinicalTrials.gov ID
- NCT02781792
- Acronym / sponsor ID
- 201605081
- Conditions
- Glioma, Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 24 May 2016 (estimated)
- Results
- Posted 27 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Temozolomide (TMZ) is the chemotherapy drug approved by the FDA to increase survival in glioblastoma (GBM) patients beyond surgical resection and radiation therapy alone. Give its activity in astrocytomas, TMZ is commonly used in grade III anaplastic astrocytoma (AA) as well. Both grade III AA and grade IV GBM are high grade gliomas (HGG). The short half-life of this drug and known oscillations in DNA damage repair make it an ideal candidate for chronotherapy.
Chronotherapy is the improvement of treatment outcomes by minimizing treatment toxicity and maximizing efficacy through delivery of a medication according to the timing of biological rhythms within a patient. Chronotherapy has improved outcomes through the reduction of side effects and increase in anti-tumor activity for a variety of cancers, but has never been applied to the treatment of gliomas.
Based on the preliminary preclinical data for chronotherapeutic TMZ treatment of intracranial glioma xenografts and the success of chronotherapy in the treatment of other cancers, the investigators hypothesize that the timing of TMZ treatment will alter its efficacy and toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Temozolomide morning | Experimental | Drug: Temozolomide, Other: Functional Assessment of Cancer Therapy - Brain, Other: ActTrust Condor Instrument Watch* Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00). * FACT-Br quality of life at baseline, at the beginning of each cycle of chemotherapy, and 1 month after the final chemotherapy treatment |
| Arm 2: Temozolomide evening | Experimental | Drug: Temozolomide, Other: Functional Assessment of Cancer Therapy - Brain, Other: ActTrust Condor Instrument Watch* Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00). * FACT-Br quality of life at baseline, at the beginning of each cycle of chemotherapy, and 1 month after the final chemotherapy treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed and recurrent high grade gliomas (WHO grades III \& IV) and high risk WHO grade II gliomas who are to begin treatment with monthly high dose temozolomide therapy.
- Scheduled to receive adjuvant temozolomide therapy after having completed concurrent temozolomide and radiation therapy.
- At least 18 years of age.
- Karnofsky performance status ≥ 60%
- Ability to understand and willingness to sign an IRB approved written informed consent document
Key exclusion criteria (1 listed)
- -Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
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 |
|---|---|---|
| TemozolomideAlso: Temodar-Given standard of care | Drug | Arm 1: Temozolomide morning, Arm 2: Temozolomide evening |
| Functional Assessment of Cancer Therapy - BrainAlso: FACT-Br* 23-item questionnaire that can be completed in 5 to 10 minutes with little or no assistance in patients who are not neurologically incapacitated. This brain subscale is usually used along with the core (general) questionnaire [2] that includes 27 items. * Patients rate all 5 items using a five-point Likert scale ranging from 0 "not at all" to 4 "very much." Overall, higher ratings suggest higher QOL. Items are totaled to produce the following subscales, along with an overall QOL score: physical well-being (7 items); social/family well-being (7 items); emotional well-being (6 items); functional well-being (7 items); and concerns relevant to patients with brain tumors (23 items) * The sleep portion of this questionnaire consists of 17 questions about sleeping patterns and the ability to rate severity of insomnia. | Other | Arm 1: Temozolomide morning, Arm 2: Temozolomide evening |
| ActTrust Condor Instrument Watch-Will be required to wear 24 hours per day and will only be removed at specified data collection time points | Other | Arm 1: Temozolomide morning, Arm 2: Temozolomide evening |
Primary outcome
Feasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time
Time frame: Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)
Compliance is defined as no more than one of five doses of temozolomide per cycle taken outside of the assigned administration time.
Duration of Response
Time frame: Through completion of follow-up (estimated to be 30 months)
* Response and progression will be evaluated in this study using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline [JCO 28(11): 1963-1972, 2010]. * The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
11 secondary outcomes
Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws
Time frame: Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)
Change in Quality of Life as Measured by FACT-Br Score - Physical Well-being Score
Time frame: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Change in Quality of Life as Measured by FACT-Br Score - Social/Family Well-being Score
Time frame: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Change in Quality of Life as Measured by FACT-Br Score - Emotional Well-being Score
Time frame: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Change in Quality of Life as Measured by FACT-Br Score - Functional Well-being Score
Time frame: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Median Progression-free Survival (PFS)
Time frame: Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days)
Median Overall Survival
Time frame: Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days)
Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening
Time frame: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening
Time frame: Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))
Mean Circadian Amplitude
Time frame: From start of treatment through 2 months after end of treatment (median length 100 days, full range 78-240 days)
Mean Sleep Regularity Index (SRI)
Time frame: From start of treatment through 2 months after end of treatment (median length 100 days, full range 78-240 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35601970Damato AR, Katumba RGN, Luo J, Atluri H, Talcott GR, Govindan A, Slat EA, Weilbaecher KN, Tao Y, Huang J, Butt OH, Ansstas G, Johanns TM, Chheda MG, Herzog ED, Rubin JB, Campian JL. A randomized feasibility study evaluating temozolomide circadian medicine in patients with glioma. Neurooncol Pract. 2022 Jan 31;9(3):193-200. doi: 10.1093/nop/npac003. eCollection 2022 May.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Milan Chheda, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide, Functional Assessment of Cancer Therapy - Brain and ActTrust Condor Instrument Watch in people with Glioma and Glioblastoma Multiforme, run by Washington University School of Medicine 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 5 inclusion and 1 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 27 Jun 2025. 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 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 27 Jun 2025). 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?
Feasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time (time frame: Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)). 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?
On the ClinicalTrials.gov record for NCT02781792, which also lists 1 linked publication.
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 27 Jun 2025.