Squamous Cell Carcinoma of the LungPhase 1/2PrE0504NCT02713828
Study of Glembatumumab Vedotin in gpNMB-Expressing, Advanced or Metastatic SCC of the Lung
A Phase 1/2 study testing Phase I: Glembatumumab Vedotin and Phase II: Glembatumumab Vedotin in people with Squamous Cell Carcinoma of the Lung, run by PrECOG, LLC. at 10 sites in United States.
Trial summary
Patients with advanced or metastatic, gpNMB-expressing Squamous Cell Carcinoma (SCC) of the lung who have failed a prior platinum-based chemotherapy regimen will receive glembatumumab vedotin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Lung
- What is being tested?
- Phase I: Glembatumumab Vedotin and Phase II: Glembatumumab Vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 10 sitesUnited States
- Study dates
- 10 Apr 2016to 26 Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures.
- Male or female patients with metastatic, histologically- or cytologically-confirmed unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC) of squamous histology (Staging per American Joint Committee on Cancer [AJCC], Edition 7). Mixed histology adenosquamous NSCLC will also be permitted.
- Experienced progression/recurrence of disease during or subsequent to the most recent anti-cancer regimen.
- Any number of prior lines of systemic therapy may have been received for advanced (recurrent, locally advanced, or metastatic) SCC of the lung, but at least one must have been a platinum-based chemotherapy regimen. Platinum therapy may be given on-label or as part of a clinical trial.
- Lung cancer confirmed to express gpNMB, as assessed by immunohistochemistry at a central lab (using expression in ≥ 5% of tumor epithelial cells as a cut-off for positivity). This can be tested on archived tissue if available, although preferred tumor specimen is a biopsy after the most recent therapy.
- Age ≥ 18 years.
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- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.
- Measurable disease by RECIST 1.1 criteria. Target lesions selected for tumor measurements should be those where surgical resection or radiation are not indicated or anticipated.
- Resolution of all toxicities related to prior therapies to ≤ NCI-CTCAE Grade 1 severity, except for alopecia, vitiligo, or endocrinopathies on replacement therapy.
- Adequate bone marrow function as assessed by absolute neutrophil count (ANC) ≥ 1500/mm3; hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 100,000/mm3.
- Adequate renal function as assessed by serum creatinine ≤ 2.0 mg/dL; or calculated or 24-hour urine creatinine clearance >40 mL/min.
- Serum albumin ≥ 3 g/dL.
- Adequate liver function as assessed by total bilirubin ≤ 1.5x upper limit of normal (ULN), and alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5x ULN (≤ 5.0x ULN in the case of liver metastases). Patients with known Gilbert's syndrome may be enrolled with total bilirubin ≤ 3.0 mg/dL.
- Both male and female patients of childbearing potential enrolled in this trial must use adequate birth control measures during the course of the trial and for at least one month after discontinuing study drug.
- Willing to provide blood samples for research purposes.
Who cannot join
- Received glembatumumab vedotin (CR011-vcMMAE; CDX-011) or other MMAE-containing agents previously.
- Chemotherapy within 21 days or at least 5 half-lives prior to the planned start of study treatment; radiation outside the thorax within 14 days prior to the planned start of study treatment or thoracic radiation; antibody based therapy or investigational therapy within 28 days prior to the planned start of study treatment.
- Neuropathy >NCI-CTCAE Grade 1.
- Subjects with a history of allergic reactions attributed to compounds of similar composition to dolastatin or auristatin. Compounds of similar composition include Auristatin PHE as an anti-fungal agent, Auristatin PE (TZT-1027, Soblidotin, NSC-654663) as an anti-tumor agent and Symplostatin 1 as an anti-tumor agent.
- Known brain metastases, unless previously treated and patients are neurologically returned to baseline except for residual signs and symptoms related to Central Nervous System (CNS) treatment and CNS lesions are not progressive in size and number for 4 weeks.
- Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, and congestive heart failure related to primary cardiac disease, a history of a serious uncontrollable arrhythmia despite treatment, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
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- Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.
- Subjects on immunosuppressive medications such as azathioprine, mycophenolate mofetil, cyclosporine or require chronic corticosteroid use (defined as ≥ 3 months of prednisone dose equivalent of ≥ 10 mg).
- The MMAE component of glembatumumab vedotin is primarily metabolized by CYP3A. Patients taking strong CYP3A inhibitor and inducers are excluded in Phase I (the dose escalation portion), to minimize the effect of these modulators on exposure, tolerability and dose selection.
- History of other malignancy except for adequately treated basal or squamous cell skin cancer, curatively treated in situ disease, or any other cancer from which the patient has been disease-free for ≥ 2 years.
- Pregnant or breast-feeding women.
- Subjects must not be on home oxygen therapy (intermittent or continuous).
- Any underlying medical condition that, in the Investigator's opinion, will make the administration of study treatment hazardous to the patient, or would obscure the interpretation of adverse events.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033
Gundersen Health System
La Crosse, Wisconsin, 54601
University of Miami Hospital
Miami, Florida, 33136
West Virginia University
Morgantown, West Virginia, 26506
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Ochsner Medical Center
New Orleans, Louisiana, 70121
Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
Stony Brook University
Stony Brook, New York, 11794-9446
About this study
Official title: A Phase I/II Study of Glembatumumab Vedotin in Patients With gpNMB-Expressing, Advanced or Metastatic Squamous Cell Carcinoma of the Lung
Patients with advanced or metastatic, gpNMB-expressing Squamous Cell Carcinoma (SCC) of the lung who have failed a prior platinum-based chemotherapy regimen will receive glembatumumab vedotin.
Glembatumumab vedotin consists of an antibody (a type of human protein) attached to a drug called Monomethyl Auristatin E (MMAE) that can kill cancer cells. Glembatumumab vedotin is intended to work by specifically directing the drug to the cancer cell. It attaches to a molecule on the cancer cell called gpNMB, and then releases the MMAE inside the tumor cell, which in turn causes the cell to die.
The purpose of this study is to see whether glembatumumab vedotin is effective in treating people who have advanced or metastatic squamous cell lung cancer that contains gpNMB, to examine how the body handles the drug and the side effects associated with glembatumumab vedotin.
Read the detailed description
Lung cancer is the most frequent cancer in the world, with annual cases worldwide currently estimated at one million and increasing to 10 million by the year 2025. In the United States, despite the declining incidence in white males in recent years, lung cancer is still the second most frequent cancer in both men (next to prostate) and women (next to breast cancer).
This is an open-label, single arm study of glembatumumab vedotin, a fully-human IgG2 monoclonal antibody. The activity of glembatumumab vedotin may be greatest in patients who overexpress the target, gpNMB.
This study will include a dose-escalation phase to determine the maximum safe and tolerated dose. This will be followed by a 2-stage Phase II expansion. During Phase II Stage 1, approximately 20 eligible, treated patients will be enrolled. If ≥ 2 patients achieve a tumor response [Partial Response (PR) or Complete Response (CR)]; an additional 15 eligible, treated patients will be enrolled in Stage 2, for a maximum total of 35 eligible, treated patients.
Glembatumumab vedotin will be administered once every 3 weeks, as a 90-minute intravenous (IV) infusion.
Patients will continue treatment until disease progression or intolerance. Tumor assessments will be performed every six (±1) weeks for six months, and every nine (±2) weeks thereafter, until progression.
A tumor tissue sample (i.e., obtained during a previous procedure or biopsy) will be sent to a central laboratory and tested for gpNMB. Research blood samples will also be required.
- Conditions
- Squamous Cell Carcinoma of the Lung
- Being tested
- Phase I: Glembatumumab Vedotin, Phase II: Glembatumumab Vedotin
- Keywords
- gpNMB-Expressing Squamous Cell Carcinoma of the Lung, Stage IIIb, Stage IV, Advanced Squamous Cell Cancer of the Lung, Metastatic Squamous Cell Cancer of the Lung, gpNMB-Expressing, Glembatumumab Vedotin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I: Glembatumumab VedotinDrug
Also called CDX-011; CR011-vcMMAE
Escalation Phase: Three to 6 patients will be enrolled in each dose cohort based on a standard Phase I dose escalation scheme. For the dose-escalation, the starting dose of glembatumumab vedotin will be 1.9 mg/kg q3w (Cohort 1). In the event of ≥ 2 DLTs, the dose will de-escalate to Cohort -1 (1.3 mg/kg).
Dose escalation from Cohort 1 to Cohort 2 (2.2 mg/kg) may proceed if three patients in Cohort 1 complete the DLT observation period with 0 DLTs, or if six patients in Cohort 1 complete the DLT observation period with 0 or 1 DLTs.
Phase II: Glembatumumab VedotinDrug
Also called CDX-011; CR011-vcMMAE
In Stage 1, approximately 20 eligible, treated patients will be enrolled. If ≥ 2 patients achieve a tumor response (Partial Response [PR] or Complete Response [CR]), an additional 15 eligible, treated patients will be enrolled in Stage 2, for a maximum total of 35 eligible, treated patients.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Glembatumumab Vedotin | Experimental | Glembatumumab vedotin once every three weeks (q3w) by 90-minute intravenous (IV) infusion, until disease progression or intolerance. The Dose-Limiting Toxicity (DLT) evaluation period for determination of the appropriateness of dose-escalation will be through the end of the second treatment cycle. Receives: Drug: Phase I: Glembatumumab Vedotin |
| Phase II: Glembatumumab Vedotin | Experimental | Glembatumumab vedotin once every three weeks (q3w) by 90-minute intravenous (IV) infusion, until disease progression or intolerance. The Maximum Tolerated Dose (MTD) determined in Phase I will be used in Phase II. Receives: Drug: Phase II: Glembatumumab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Determine Maximum Tolerated Dose (MTD)
To determine the Maximum Tolerated Dose (MTD) by number of participants with DLTs.
Measured: 42 (±3) days
Phase II: Objective Response Rate (ORR)
Determine the anti-tumor activity, as assessed by ORR in accordance with RECIST 1.1, of the MTD of glembatumumab vedotin in patients with advanced gpNMB-expressing SCC of the lung.
Measured: 40 months
Secondary outcomes (4)
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0.
To further characterize the safety of glembatumumab vedotin by the number of participants with abnormal laboratory values and/or adverse events related to treatment (including Serious Adverse Events and Other Adverse Events).
Measured: 23 months
Duration of Objective Response (DOR)
DOR assessed in accordance with RECIST 1.1.
Measured: 23 months
Progression-Free Survival (PFS)
PFS assessed in accordance with RECIST 1.1.
Measured: 23 months
Overall Survival (OS)
OS assessed in accordance with RECIST 1.1.
Measured: 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study start10 Apr 2016
- Primary completion29 May 2018
- Study completion26 Sep 2018
Why it stopped: Company discontinued further development of study drug for this indication
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 Squamous Cell Carcinoma of the LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- PrECOG, LLC.
- Sponsor type
- University, hospital or other
- Collaborators
- Celldex Therapeutics
- Responsible party
- Sponsor
- Investigators
- Rathi Pillai, MD, Study chair, PrECOG, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713828
- Sponsor's protocol ID
- PrE0504
- Other IDs
- CDX011-54
- Acronym
- PrE0504
- Status last verified
- Jun 2019
- First submitted
- 8 Mar 2016
- Last updated
- 16 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data is proprietary.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Glembatumumab Vedotin in Patients With gpNMB-Expressing, Advanced or Metastatic Squamous Cell Carcinoma of the Lung
- ClinicalTrials.gov ID
- NCT02713828
- Acronym / sponsor ID
- PrE0504 / PrE0504
- Conditions
- Squamous Cell Carcinoma of the Lung
- Keywords
- gpNMB-Expressing Squamous Cell Carcinoma of the Lung, Stage IIIb, Stage IV, Advanced Squamous Cell Cancer of the Lung, Metastatic Squamous Cell Cancer of the Lung, gpNMB-Expressing, Glembatumumab Vedotin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company discontinued further development of study drug for this indication
- Enrolment
- 13 participants (actual)
- Lead sponsor
- PrECOG, LLC.University, hospital or other
- Collaborators
- Celldex Therapeutics
- Study start
- 10 Apr 2016 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Posted 16 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with advanced or metastatic, gpNMB-expressing Squamous Cell Carcinoma (SCC) of the lung who have failed a prior platinum-based chemotherapy regimen will receive glembatumumab vedotin.
Glembatumumab vedotin consists of an antibody (a type of human protein) attached to a drug called Monomethyl Auristatin E (MMAE) that can kill cancer cells. Glembatumumab vedotin is intended to work by specifically directing the drug to the cancer cell. It attaches to a molecule on the cancer cell called gpNMB, and then releases the MMAE inside the tumor cell, which in turn causes the cell to die.
The purpose of this study is to see whether glembatumumab vedotin is effective in treating people who have advanced or metastatic squamous cell lung cancer that contains gpNMB, to examine how the body handles the drug and the side effects associated with glembatumumab vedotin.
Detailed description
Lung cancer is the most frequent cancer in the world, with annual cases worldwide currently estimated at one million and increasing to 10 million by the year 2025. In the United States, despite the declining incidence in white males in recent years, lung cancer is still the second most frequent cancer in both men (next to prostate) and women (next to breast cancer).
This is an open-label, single arm study of glembatumumab vedotin, a fully-human IgG2 monoclonal antibody. The activity of glembatumumab vedotin may be greatest in patients who overexpress the target, gpNMB.
This study will include a dose-escalation phase to determine the maximum safe and tolerated dose. This will be followed by a 2-stage Phase II expansion. During Phase II Stage 1, approximately 20 eligible, treated patients will be enrolled. If ≥ 2 patients achieve a tumor response [Partial Response (PR) or Complete Response (CR)]; an additional 15 eligible, treated patients will be enrolled in Stage 2, for a maximum total of 35 eligible, treated patients.
Glembatumumab vedotin will be administered once every 3 weeks, as a 90-minute intravenous (IV) infusion.
Patients will continue treatment until disease progression or intolerance. Tumor assessments will be performed every six (±1) weeks for six months, and every nine (±2) weeks thereafter, until progression.
A tumor tissue sample (i.e., obtained during a previous procedure or biopsy) will be sent to a central laboratory and tested for gpNMB. Research blood samples will also be required.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I: Glembatumumab Vedotin | Experimental | Drug: Phase I: Glembatumumab VedotinGlembatumumab vedotin once every three weeks (q3w) by 90-minute intravenous (IV) infusion, until disease progression or intolerance. The Dose-Limiting Toxicity (DLT) evaluation period for determination of the appropriateness of dose-escalation will be through the end of the second treatment cycle. |
| Phase II: Glembatumumab Vedotin | Experimental | Drug: Phase II: Glembatumumab VedotinGlembatumumab vedotin once every three weeks (q3w) by 90-minute intravenous (IV) infusion, until disease progression or intolerance. The Maximum Tolerated Dose (MTD) determined in Phase I will be used in Phase II. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures.
- Male or female patients with metastatic, histologically- or cytologically-confirmed unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC) of squamous histology (Staging per American Joint Committee on Cancer [AJCC], Edition 7). Mixed histology adenosquamous NSCLC will also be permitted.
- Experienced progression/recurrence of disease during or subsequent to the most recent anti-cancer regimen.
- Any number of prior lines of systemic therapy may have been received for advanced (recurrent, locally advanced, or metastatic) SCC of the lung, but at least one must have been a platinum-based chemotherapy regimen. Platinum therapy may be given on-label or as part of a clinical trial.
- Lung cancer confirmed to express gpNMB, as assessed by immunohistochemistry at a central lab (using expression in ≥ 5% of tumor epithelial cells as a cut-off for positivity). This can be tested on archived tissue if available, although preferred tumor specimen is a biopsy after the most recent therapy.
Key exclusion criteria (13 listed)
- Received glembatumumab vedotin (CR011-vcMMAE; CDX-011) or other MMAE-containing agents previously.
- Chemotherapy within 21 days or at least 5 half-lives prior to the planned start of study treatment; radiation outside the thorax within 14 days prior to the planned start of study treatment or thoracic radiation; antibody based therapy or investigational therapy within 28 days prior to the planned start of study treatment.
- Neuropathy >NCI-CTCAE Grade 1.
- Subjects with a history of allergic reactions attributed to compounds of similar composition to dolastatin or auristatin. Compounds of similar composition include Auristatin PHE as an anti-fungal agent, Auristatin PE (TZT-1027, Soblidotin, NSC-654663) as an anti-tumor agent and Symplostatin 1 as an anti-tumor agent.
- Known brain metastases, unless previously treated and patients are neurologically returned to baseline except for residual signs and symptoms related to Central Nervous System (CNS) treatment and CNS lesions are not progressive in size and number for 4 weeks.
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 |
|---|---|---|
| Phase I: Glembatumumab VedotinAlso: CDX-011; CR011-vcMMAEEscalation Phase: Three to 6 patients will be enrolled in each dose cohort based on a standard Phase I dose escalation scheme. For the dose-escalation, the starting dose of glembatumumab vedotin will be 1.9 mg/kg q3w (Cohort 1). In the event of ≥ 2 DLTs, the dose will de-escalate to Cohort -1 (1.3 mg/kg). Dose escalation from Cohort 1 to Cohort 2 (2.2 mg/kg) may proceed if three patients in Cohort 1 complete the DLT observation period with 0 DLTs, or if six patients in Cohort 1 complete the DLT observation period with 0 or 1 DLTs. | Drug | Phase I: Glembatumumab Vedotin |
| Phase II: Glembatumumab VedotinAlso: CDX-011; CR011-vcMMAEIn Stage 1, approximately 20 eligible, treated patients will be enrolled. If ≥ 2 patients achieve a tumor response (Partial Response [PR] or Complete Response [CR]), an additional 15 eligible, treated patients will be enrolled in Stage 2, for a maximum total of 35 eligible, treated patients. | Drug | Phase II: Glembatumumab Vedotin |
Primary outcome
Phase I: Determine Maximum Tolerated Dose (MTD)
Time frame: 42 (±3) days
To determine the Maximum Tolerated Dose (MTD) by number of participants with DLTs.
Phase II: Objective Response Rate (ORR)
Time frame: 40 months
Determine the anti-tumor activity, as assessed by ORR in accordance with RECIST 1.1, of the MTD of glembatumumab vedotin in patients with advanced gpNMB-expressing SCC of the lung.
4 secondary outcomes
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0.
Time frame: 23 months
Duration of Objective Response (DOR)
Time frame: 23 months
Progression-Free Survival (PFS)
Time frame: 23 months
Overall Survival (OS)
Time frame: 23 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data is proprietary.
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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.
Rathi Pillai, MD study chair
PrECOG, LLC.
10 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 Phase I: Glembatumumab Vedotin and Phase II: Glembatumumab Vedotin in people with Squamous Cell Carcinoma of the Lung, run by PrECOG, LLC. at 10 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 15 inclusion and 13 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: stopped early, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 16 Jul 2019). 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?
Phase I: Determine Maximum Tolerated Dose (MTD) (time frame: 42 (±3) days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.