GlioblastomaPhase 2NCT02844439
Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma
A Phase 2 study testing Tesevatinib in people with Glioblastoma and Recurrent Glioblastoma, run by Kadmon Corporation, LLC at 11 sites in United States.
Trial summary
This is a multicenter, Phase 2 study to assess the activity of tesevatinib in patients with recurrent glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Recurrent Glioblastoma, Brain Tumor
- What is being tested?
- Tesevatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2016to 30 Apr 2020
- 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
- Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator
- Age ≥ 18 years old
- Kamofsky performance status ≥70%
- Stable or decreasing dose of corticosteroids within 5 days prior to study 5. enrollment.
- For women who are not postmenopausal (i.e., < 12 months after last menstruation) or surgically sterile (absence of ovaries and/or uterus) and who are sexually active: agreement to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly) during the treatment period and for at least 6 months after the last dose of study drug.
- For male patients who are sexually active and who are partners of premenopausal women: agreement to use a barrier method of contraception during the treatment period and for at least 6 months after the last dose of study drug.
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- Histologically confirmed glioblastoma. A local pathology report constitutes adequate documentation of histology for study inclusion. Patients with an initial diagnosis of a lower-grade glioma are eligible if a subsequent biopsy was determined to be glioblastoma.
- First recurrence after concurrent or adjuvant chemoradiotherapy. Imaging confirmation of first tumor progression or regrowth as defined by the RANO criteria . A minimum of 12 weeks must have elapsed from the completion of radiotherapy to study entry to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progression of disease, unless there is a new lesion outside the radiation field or unequivocal evidence of viable tumor on histopathological sampling.
- Prior treatment with TMZ for low grade glioma or glioblastoma.
- No more than one prior line of systemic treatment for glioblastoma. Concurrent and adjuvant TMZ-based chemotherapy, including the combination of TMZ with an investigational agent, is considered one line of therapy.
- Prior therapy with gamma knife or other focal high-dose radiotherapy is allowed, but the patient must have subsequent histologic documentation of recurrence, unless the recurrence is a new lesion outside the irradiated field.
- Recovery from the toxic effects of prior therapy, with a minimum time of:
- ≥ 28 days elapsed from the administration of any prior cytotoxic agents, except ≥ 14 days from vincristine, ≥ 21 days from procarbazine, and ≥ 42 days from nitrosureas
- ≥ 28 days elapsed from the administration of any investigational agent
- ≥ 14 days elapsed from administration of any non-cytotoxic agent (e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid)
- Patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that:
- Surgery must have confirmed the recurrence
- There must be residual disease
- A minimum of 28 days must have elapsed from the day of surgery to first dose of the study drug. For core or needle biopsy, a minimum of 7 days must have elapsed prior to study entry
- Availability of formalin-fixed paraffin-embedded tumor tissue diagnostic of glioblastoma.
Who cannot join
- Concurrent therapeutic intervention (including radiation therapy and NovoTTF).
- Prior exposure to EGFR inhibitors.
- Prior exposure to bevacizumab or other VEGF- or VEGF-receptor-targeted agent within 8 weeks of study start.
- Prior treatment with prolifeprospan 20 with carmustine wafer.
- Prior intracerebral agent.
- Evidence of recent hemorrhage on baseline MRI of the brain. However, patients with clinically asymptomatic presence of hemosiderin, resolving hemorrhagic changes related to surgery, or presence of punctuate hemorrhage in the tumor are eligible.
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- Need for urgent palliative intervention for primary disease (e.g., rapidly increasing intracranial pressure, impending herniation, uncontrolled seizures).
- Hematology:
- ANC < 1.5 x109/L; Plt < 100 x109/L Hgb < 9.0 g/dL within 7 days prior to enrollment. The use of transfusion or other intervention to achieve Hb ≥ 9 g/dL is acceptable.
- T.Bili. ≥ 1.5 x ULN (except in patients diagnosed with Gilbert's disease).
- AST(SGOT), ALT(SGPT), or alkaline phosphatase (ALP) ≥ 2.5 x ULN.
- S. Creat. > 1.5 x ULN.
- K+ or Mg+ < LLN.
- In the absence of therapeutic intent to anticoagulate the patient: INR > 1.5 or PT > 1.5 xULN or aPTT > 1.5 xULN Therapeutic anticoagulation.
- Known contraindication to MRI, such as cardiac pacemaker, shrapnel or ocular foreign body.
- Used any prescription medication during the prior 2 weeks that the investigator judges is likely to interfere with the study or to pose an additional risk to the patient in participating, specifically inhibitors or inducers of cytochrome P450 (CYP)3A4 (refer to Appendix 5). A stable regimen (≥ 4 weeks) of antidepressants of the selective serotonin re-uptake inhibitor (SSRI) class is allowed (common SSRIs include escitalopram oxalate, citalopram, fluvoxamine, paroxetine, sertraline, and fluoxetine).
- Taking any drugs associated with torsades de pointes or known to moderately or severely prolong the QTc(F) interval
- History of torsades de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (< 50 bpm), heart block (excluding first degree block, being PR interval only), or congenital long QT syndrome. Patients with a history of atrial arrhythmias should be discussed with the Medical Monitor.
- Uncontrolled diabetes, as evidenced by fasting serum glucose level >200 mg/dL
- New York Heart Association (NYHA) Grade II or greater congestive cardiac failure.
- Has marked prolongation of QTc(F) interval at screening or baseline (QTc[F] interval > 470 msec) using the Fridericia method of correction for heart rate.
- History of myocardial infarction (within 12 months) or unstable angina (within 6 months) prior to study enrolment.
- History of stroke or transient ischemic attacks within 6 months prior to study enrolment.
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study enrolment.
- Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
- History of intracranial abscess within 6 months prior to study enrolment.
- History of another malignancy in the previous 3 years, with a disease-free interval of < 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
- Evidence of any active infection requiring hospitalization or IV antibiotics within 2 weeks prior to study enrolment.
- Known hypersensitivity to any excipients of tesevatinib.
- Inability to swallow or absorb orally-administered medication.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Hospital
Detroit, Michigan, 48202
City of Hope
Duarte, California, 91010
UT MD Anderson Cancer Center
Houston, Texas, 77030
Columbia University, Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of California, San Francisco (UCSF)
San Francisco, California, 94143
Center for Neurosciences
Tucson, Arizona, 85718
About this study
Official title: A Phase 2, Multicenter Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma
This is a multicenter, Phase 2 study to assess the activity of tesevatinib in patients with recurrent glioblastoma.
Read the detailed description
This is a multicenter, Phase 2 study to assess the activity of tesevatinib in subjects (n = 40) with recurrent glioblastoma. This study will be conducted at up to 10 sites in the United States.
The availability of paraffin-embedded tumor sample diagnostic of glioblastoma is mandatory for entry into the study. Tumor samples will be evaluated for the EGFRvIII mutation and for EGFR gene amplification. Tissue from recurrent surgery is preferred, but tissue from initial surgery is sufficient for study entry. Baseline MRI is mandatory.
After completion of the screening assessments and confirmation of study eligibility by the Medical Monitor upon review of an inclusion package, tesevatinib will be orally administered to all patients at a dose of 300 mg once daily. A cycle will be considered as 28 days. Patients will be evaluated for efficacy according to the Response Assessment in Neuro-Oncology (RANO) criteria.
Patients who develop ≥ Grade 3 adverse event(s) considered by the investigator to be related to study drug will have study treatment interrupted until the drug-related toxicities have resolved to ≤ Grade 1. Once toxicities have resolved to ≤ Grade 1, the patient may resume study treatment at a reduced dose of 250 mg/day. No more than 1 dose reduction is permitted. Patients who require more than one dose reduction will have study drug discontinued and enter the Follow-up Period.
Patients for whom toxicity persists beyond 21 days despite dose interruption may resume study treatment only with permission from the responsible Medical Monitor.
If study treatment is withheld, the patient should be instructed not to make up the withheld doses.
Study treatment will continue until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death. Assessments for disease response will occur at Week 4 and Week 8 and then every 8 weeks thereafter using the RANO criteria.
Upon treatment discontinuation, patients will be followed every 8 weeks for survival.
Tumor samples will be used for exploratory biomarker research including, but not limited to, evaluation of EGFRvIII expression by immunohistochemistry or real-time Polymerase Chain Reaction. An appropriate definition and cutoff for EGFRvIII^pos tumors will be established, and outcome in this subpopulation will be evaluated in addition to the overall study population.
To characterize the safety and tolerability profile of tesevatinib, patients will be monitored throughout the study for adverse events (all grades), serious adverse events, and any adverse events requiring drug interruption or discontinuation. Patients will undergo safety evaluations, including physical examinations, Karnofsky Performance Status (KPS), vital sign measurements, hematology, serum chemistry, urinalysis and electrocardiogram.
Magnetic resonance imaging (MRI) will be used to evaluate the tumor at baseline. All MRIs taken on study patients will be submitted to the sponsor for possible retrospective analysis.
- Conditions
- Glioblastoma, Recurrent Glioblastoma, Brain Tumor
- Being tested
- Tesevatinib
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesevatinibDrug
Also called KD019, XL647
| Study group | Role | What they receive |
|---|---|---|
| Glioblastoma | Experimental | The single arm design assessing progression-free survival at 6 months (PFS-6) in the overall population with the ability to detect a rate of 25% is appropriate as a preliminary test of activity in patients with glioblastoma. The sample size of this study is also designed to permit the comparison of results with EGFR amplified and non-amplified tumors, as well as EGFRvIII mutated versus wild-type. The sample size is adequate to characterize the safety profile in patients with glioblastoma. Receives: Drug: Tesevatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Median Progression-free Survival (PFS) Rate at 6 Months (PFS-6)
Proportion (%) of subjects who did not have progressive disease after treatment with tesevatinib at 6 months (PFS-6) after baseline
Measured: 6 months
Secondary outcomes (9)
Efficacy: Median PFS
Median duration (months) of subjects who were progression-free of disease from baseline
Measured: Until disease progression, unacceptable toxicity, subject or clinician decision to discontinue, death, or up to 3 years, whichever occurred first
Efficacy: Median Overall Survival Rate at 9 Months (OS-9)
Median proportion (%) of subjects who survived 9 months after baseline
Measured: 9 months
Efficacy: Median OS
Median duration (months) subjects survived from baseline until death
Measured: Until unacceptable toxicity, subject or investigator decision to discontinue, death, or up to 3 years, whichever occurred first
Efficacy: Best Overall Response
Best overall response that subjects had to treatment with tesevatinib: complete response (CR), partial response (PR), stable disease (SD), or non-response/progressive disease (PD)
Measured: Until disease progression, unacceptable toxicity, subject or investigator decision to discontinue, death, or up to 3 years, whichever occurred first
Efficacy: Objective Response Rate (ORR)
Proportion (%) of subjects who had either a complete response (CR) or a partial response (PR) to treatment with tesevatinib
Measured: Until disease progression, unacceptable toxicity, subject or investigator decision to discontinue, death, or 3 years, whichever occurred first
Exposure to Tesevatinib: Overall Mean
Mean total amount of tesevatinib (mg) subjects received during the study
Measured: Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first
Exposure to Tesevatinib: Overall Median
Median amount of tesevatinib (mg) subjects received during the study
Measured: Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first
Exposure to Tesevatinib: Mean Number of Cycles
Mean number of 28-day cycles of treatment with tesevatinib subjects received during the study
Measured: Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first.
Exposure to Tesevatinib: Median Number of Cycles
Median number of 28-day cycles of treatment with tesevatinib subjects received during the study
Measured: Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJun 2016
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
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 GlioblastomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kadmon Corporation, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844439
- Sponsor's protocol ID
- KD019-208
- Status last verified
- Aug 2021
- First submitted
- 24 Jun 2016
- Last updated
- 22 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT02844439
- Acronym / sponsor ID
- KD019-208
- Conditions
- Glioblastoma, Recurrent Glioblastoma, Brain Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kadmon Corporation, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Posted 22 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, Phase 2 study to assess the activity of tesevatinib in patients with recurrent glioblastoma.
Detailed description
This is a multicenter, Phase 2 study to assess the activity of tesevatinib in subjects (n = 40) with recurrent glioblastoma. This study will be conducted at up to 10 sites in the United States.
The availability of paraffin-embedded tumor sample diagnostic of glioblastoma is mandatory for entry into the study. Tumor samples will be evaluated for the EGFRvIII mutation and for EGFR gene amplification. Tissue from recurrent surgery is preferred, but tissue from initial surgery is sufficient for study entry. Baseline MRI is mandatory.
After completion of the screening assessments and confirmation of study eligibility by the Medical Monitor upon review of an inclusion package, tesevatinib will be orally administered to all patients at a dose of 300 mg once daily. A cycle will be considered as 28 days. Patients will be evaluated for efficacy according to the Response Assessment in Neuro-Oncology (RANO) criteria.
Patients who develop ≥ Grade 3 adverse event(s) considered by the investigator to be related to study drug will have study treatment interrupted until the drug-related toxicities have resolved to ≤ Grade 1. Once toxicities have resolved to ≤ Grade 1, the patient may resume study treatment at a reduced dose of 250 mg/day. No more than 1 dose reduction is permitted. Patients who require more than one dose reduction will have study drug discontinued and enter the Follow-up Period.
Patients for whom toxicity persists beyond 21 days despite dose interruption may resume study treatment only with permission from the responsible Medical Monitor.
If study treatment is withheld, the patient should be instructed not to make up the withheld doses.
Study treatment will continue until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death. Assessments for disease response will occur at Week 4 and Week 8 and then every 8 weeks thereafter using the RANO criteria.
Upon treatment discontinuation, patients will be followed every 8 weeks for survival.
Tumor samples will be used for exploratory biomarker research including, but not limited to, evaluation of EGFRvIII expression by immunohistochemistry or real-time Polymerase Chain Reaction. An appropriate definition and cutoff for EGFRvIII^pos tumors will be established, and outcome in this subpopulation will be evaluated in addition to the overall study population.
To characterize the safety and tolerability profile of tesevatinib, patients will be monitored throughout the study for adverse events (all grades), serious adverse events, and any adverse events requiring drug interruption or discontinuation. Patients will undergo safety evaluations, including physical examinations, Karnofsky Performance Status (KPS), vital sign measurements, hematology, serum chemistry, urinalysis and electrocardiogram.
Magnetic resonance imaging (MRI) will be used to evaluate the tumor at baseline. All MRIs taken on study patients will be submitted to the sponsor for possible retrospective analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glioblastoma | Experimental | Drug: TesevatinibThe single arm design assessing progression-free survival at 6 months (PFS-6) in the overall population with the ability to detect a rate of 25% is appropriate as a preliminary test of activity in patients with glioblastoma. The sample size of this study is also designed to permit the comparison of results with EGFR amplified and non-amplified tumors, as well as EGFRvIII mutated versus wild-type. The sample size is adequate to characterize the safety profile in patients with glioblastoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator
- Age ≥ 18 years old
- Kamofsky performance status ≥70%
- Stable or decreasing dose of corticosteroids within 5 days prior to study 5. enrollment.
- For women who are not postmenopausal (i.e., < 12 months after last menstruation) or surgically sterile (absence of ovaries and/or uterus) and who are sexually active: agreement to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly) during the treatment period and for at least 6 months after the last dose of study drug.
Key exclusion criteria (30 listed)
- Concurrent therapeutic intervention (including radiation therapy and NovoTTF).
- Prior exposure to EGFR inhibitors.
- Prior exposure to bevacizumab or other VEGF- or VEGF-receptor-targeted agent within 8 weeks of study start.
- Prior treatment with prolifeprospan 20 with carmustine wafer.
- Prior intracerebral agent.
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 |
|---|---|---|
| TesevatinibAlso: KD019, XL647 | Drug | Glioblastoma |
Primary outcome
Efficacy: Median Progression-free Survival (PFS) Rate at 6 Months (PFS-6)
Time frame: 6 months
Proportion (%) of subjects who did not have progressive disease after treatment with tesevatinib at 6 months (PFS-6) after baseline
9 secondary outcomes
Efficacy: Median PFS
Time frame: Until disease progression, unacceptable toxicity, subject or clinician decision to discontinue, death, or up to 3 years, whichever occurred first
Efficacy: Median Overall Survival Rate at 9 Months (OS-9)
Time frame: 9 months
Efficacy: Median OS
Time frame: Until unacceptable toxicity, subject or investigator decision to discontinue, death, or up to 3 years, whichever occurred first
Efficacy: Best Overall Response
Time frame: Until disease progression, unacceptable toxicity, subject or investigator decision to discontinue, death, or up to 3 years, whichever occurred first
Efficacy: Objective Response Rate (ORR)
Time frame: Until disease progression, unacceptable toxicity, subject or investigator decision to discontinue, death, or 3 years, whichever occurred first
Exposure to Tesevatinib: Overall Mean
Time frame: Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first
Exposure to Tesevatinib: Overall Median
Time frame: Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first
Exposure to Tesevatinib: Mean Number of Cycles
Time frame: Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first.
Exposure to Tesevatinib: Median Number of Cycles
Time frame: Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tesevatinib in people with Glioblastoma and Recurrent Glioblastoma, run by Kadmon Corporation, LLC at 11 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 20 inclusion and 30 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 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 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 22 Sep 2021). 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?
Efficacy: Median Progression-free Survival (PFS) Rate at 6 Months (PFS-6) (time frame: 6 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 22 Sep 2021.