Non-small Cell Lung CancerPhase 1/2NCT02630186
A Phase 1b/2 Study of Safety and Efficacy of Rociletinib in Combination With MPDL3280A in Patients With Advanced or Metastatic EGFR-mutant NSCLC
A Phase 1/2 study testing Rociletinib and MPDL3280A in people with Non-small Cell Lung Cancer, run by Clovis Oncology, Inc. at 1 site in United States.
Trial summary
This clinical research study is being carried out in two parts, Phase 1 and Phase 2. The primary purpose of the Phase 1 portion of the study is to observe the safety of the combination of rociletinib and MPDL3280A in EGFR-mutant NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Rociletinib and MPDL3280A
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2016to 5 Sep 2017
- 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
- ECOG performance status of 0 or 1
- Adequate hematological and biological function, confirmed by defined laboratory values
- Histologically or cytologically documented metastatic or unresectable, locally advanced or metastatic NSCLC, with one or more activating EGFR mutation (eg, G719X, exon 19 deletion, L858R, L861Q) and absence of exon 20 insertion
- Measurable disease as defined by RECIST v1.1
- Biopsy of tumor tissue for central evaluation, within 60 days prior to the first day of study treatment
- For Phase 1 and Phase 2 Group B, progression after prior 1st or 2nd generation EGFR TKI (eg, erlotinib, gefitinib, afatinib). Previous chemotherapy for NSCLC is allowed.
- For Phase 2 Group A, EGFR TKI treatment-naïve and chemotherapy-naïve
Who cannot join
- Unresolved toxicities from prior therapy
- Symptomatic, untreated or unstable central nervous system or leptomeningeal metastases
- Previous treatment with rociletinib or MPDL3280A, or other 3rd generation EGFR TKI (eg, AZD-9291, HM61713), or PD 1 axis targeted therapy (eg, anti PD 1 or anti-PD L1)
- Prior treatment with CD137 agonists or other immune checkpoint blockade therapies, including anti-CTLA-4 therapeutic antibodies
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures
- Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab (bisphosphonate use for prevention of skeletal events allowed)
Show all 17Show fewer
- Known hypersensitivity to any component of the MPDL3280A or rociletinib formulations or history or hypersensitivity to chimeric humanized antibodies or fusion proteins
- History of autoimmune disease
- History of prior allogeneic hematopoietic stem cell transplantation or prior solid organ transplantation
- Treatment with systemic immunosuppressive medications within 2 weeks prior to first day of study treatment (inhaled corticosteroids and mineralocorticoids allowed)
- Live attenuated vaccine within 4 weeks prior to first day of study treatment
- Active tuberculosis, active hepatitis, or positive HIV status
- Class II to IV heart failure as defined by the New York Heart Association functional classification system
- Untreated or uncontrolled cardiovascular disease or other symptomatic cardiac dysfunction
- QTCF > 450 ms, inability to measure QT interval on ECG, personal or family history of long QT syndrome, requirement for medications that have the potential to prolong the QT interval
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan (history of radiation pneumonitis in radiation field may be allowed)
- Other malignancies within 5 years prior to enrollment, with the exception of carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at Los Angeles
Santa Monica, California, 90404
About this study
Official title: A Phase 1b/2 Study of the Safety and Efficacy of Rociletinib (CO-1686) Administered in Combination With MPDL3280A in Patients With Activating EGFR Mutation-positive (EGFRm) Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
This clinical research study is being carried out in two parts, Phase 1 and Phase 2. The primary purpose of the Phase 1 portion of the study is to observe the safety of the combination of rociletinib and MPDL3280A in EGFR-mutant NSCLC patients.
The primary purpose of the Phase 2 portion of the study is to evaluate the safety and anti-tumor effects of the combination of rociletinib and MPDL3280A, at the best doses for the combination determined in Phase 1, in patients with EGFR-mutant NSCLC.
Read the detailed description
This is a Phase 1b/2, open-label, non-randomized, multicenter study evaluating the safety and efficacy of rociletinib administered in combination with MPDL3280A.
Phase 1: This will be the dose finding phase of the study. Patients will be enrolled to available Dosing Cohort. Patients who have progressed after prior first- or second-generation EGFR TKI, regardless of T790M mutation status, will be enrolled.
Phase 2: Patients will be enrolled into 2 groups. Group A will enroll eligible first-line patients who are EGFR TKI treatment-naïve and chemotherapy-naïve. Group B will enroll eligible patients who have progressed after prior first- or second-generation EGFR TKI, regardless of T790M mutation status.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Rociletinib, MPDL3280A
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RociletinibDrug
Also called CO-1686
A novel, potent, covalent (irreversible) small molecule, tyrosine kinase inhibitor (TKI) administered orally (PO) to patients with EGFRm NSCLC.
MPDL3280ADrug
Also called atezolizumab
A human IgG1 monoclonal antibody administered intravenously (IV)
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Rociletinib and MPDL3280A | Experimental | Specific doses of rociletinib, taken continuously BID, will be administered in combination with a fixed dose of MPDL3280A, given intravenously on Day 1 of each 21-day cycle. Receives: Drug: Rociletinib; Drug: MPDL3280A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-emergent Adverse Events, as Assessed by NCI CTCAE v4.03
The safety analyses will be performed using the safety population. Safety data analysis will be conducted on all patients receiving at least one dose of rociletinib or MPDL3280A.
Measured: Continuously, up to approximately 18.5 months
Maximum Concentration (Cmax) of Rociletinib and Its Metabolites
Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmax will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.
Measured: Treatment Day 1 and Day 15
Time to Maximum Concentration (Tmax) for Rociletinib and Rociletinib Metabolites
Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Tmax will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.
Measured: Treatment Day 1 and Day 15
Minimum Concentration (Cmin) of Rociletinib and Metabolites
Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmin will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.
Measured: Approximately every 6 weeks up to 24 months
Area Under the Curve (AUC) of Rociletinib and Rociletinib Metabolites
Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. AUC0 24 will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.
Measured: Treatment Day 1 and Day 8
Maximum Concentration (Cmax) of MPDL3280A
Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmax, for MPDL3280A will be assessed using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.
Measured: Cycle 1 Day 1
Minimum Concentration (Cmin) of MPDL3280A
Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmin for MPDL3280A will be assessed using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.
Measured: Approximately every 6 weeks up to 24 months
Objective Response Rate Per RECIST v1.1 in Phase 2
To determine the efficacy of the combination of rociletinib and MPDL3280A based on overall response rate per RECIST v1.1 in the following groups of patients:
- Group A: Patients with EGFRm advanced or metastatic NSCLC who have not previously received an EGFR TKI or chemotherapy.
- Group B: Patients with EGFRm advanced or metastatic NSCLC who have progressed on a prior EGFR TKI.
Measured: Approximately every 6-9 weeks
Secondary outcomes (5)
Objective Response Rate Per Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2
Conventional response criteria may not be adequate to characterize the antitumor activity of immunotherapeutic agents like MPDL3280A, which can produce delayed responses that may be preceded by initial apparent radiological progression, including the appearance of new lesions. Therefore, modified response criteria have been developed that account for the possible appearance of new lesions and allow radiological progression to be confirmed at a subsequent assessment. In this protocol, patients will be permitted to continue study treatment even after modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease are met if the benefit-risk ratio is judged to be favorable.
These modified criteria are derived from RECIST version 1.1 (v1.1) conventions and immune related response criteria (irRC).
Measured: Approximately every 6-9 weeks, up to 24 months
Duration of Response Per RECIST v1.1 and Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2
Conventional response criteria may not be adequate to characterize the antitumor activity of immunotherapeutic agents like MPDL3280A, which can produce delayed responses that may be preceded by initial apparent radiological progression, including the appearance of new lesions. Therefore, modified response criteria have been developed that account for the possible appearance of new lesions and allow radiological progression to be confirmed at a subsequent assessment. In this protocol, patients will be permitted to continue study treatment even after modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease are met if the benefit-risk ratio is judged to be favorable.
These modified criteria are derived from RECIST version 1.1 (v1.1) conventions and immune related response criteria (irRC).
Measured: Approximately every 6-9 weeks, up to 24 months
Progression-free Survival Per RECIST v1.1 and Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2
Conventional response criteria may not be adequate to characterize the antitumor activity of immunotherapeutic agents like MPDL3280A, which can produce delayed responses that may be preceded by initial apparent radiological progression, including the appearance of new lesions. Therefore, modified response criteria have been developed that account for the possible appearance of new lesions and allow radiological progression to be confirmed at a subsequent assessment. In this protocol, patients will be permitted to continue study treatment even after modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease are met if the benefit-risk ratio is judged to be favorable.
These modified criteria are derived from RECIST version 1.1 (v1.1) conventions and immune related response criteria (irRC).
Measured: Approximately every 6-9 weeks, up to 24 months
Number of Patients Alive at Study Termination
Patients who received the combination of rociletinib and MPDL3280A alive at the termination of this study.
Measured: Up to approximately 18.5 months
Longitudinal Changes in Blood Based Biomarkers (eg, Mutations in EGFR) in ctDNA
Tumor tissue, plasma, and blood specimens will be used for pharmacodynamic assessment of rociletinib and/or MPDL3280A activity, to evaluate the concordance of mutant EGFR detection between tissue and plasma, and to explore biomarkers that may be predictive of response or resistance to rociletinib and/or MPDL3280A. Biomarkers and changes in biomarker status will be investigated for associations with rociletinib and/or MPDL3280A exposure, safety, and clinical activity. Given the limited sample size, no formal statistical analysis is planned.
Measured: Blood samples will be collected from each patient approximately every 3 weeks, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study start24 Feb 2016
- Primary completion5 Sep 2017
- Study completion5 Sep 2017
Why it stopped: The study terminated before Phase 1 was completed. This study was reprioritized within the rociletinib development program.
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 Non-small Cell Lung CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clovis Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Lindsey Rolfe, MD, Study director, Clovis Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630186
- Sponsor's protocol ID
- CO-1686-032
- Status last verified
- Jun 2019
- First submitted
- 2 Dec 2015
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Study of the Safety and Efficacy of Rociletinib (CO-1686) Administered in Combination With MPDL3280A in Patients With Activating EGFR Mutation-positive (EGFRm) Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02630186
- Acronym / sponsor ID
- CO-1686-032
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study terminated before Phase 1 was completed. This study was reprioritized within the rociletinib development program.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Clovis Oncology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- 24 Feb 2016 (actual)
- Primary completion
- 5 Sep 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical research study is being carried out in two parts, Phase 1 and Phase 2. The primary purpose of the Phase 1 portion of the study is to observe the safety of the combination of rociletinib and MPDL3280A in EGFR-mutant NSCLC patients.
The primary purpose of the Phase 2 portion of the study is to evaluate the safety and anti-tumor effects of the combination of rociletinib and MPDL3280A, at the best doses for the combination determined in Phase 1, in patients with EGFR-mutant NSCLC.
Detailed description
This is a Phase 1b/2, open-label, non-randomized, multicenter study evaluating the safety and efficacy of rociletinib administered in combination with MPDL3280A.
Phase 1: This will be the dose finding phase of the study. Patients will be enrolled to available Dosing Cohort. Patients who have progressed after prior first- or second-generation EGFR TKI, regardless of T790M mutation status, will be enrolled.
Phase 2: Patients will be enrolled into 2 groups. Group A will enroll eligible first-line patients who are EGFR TKI treatment-naïve and chemotherapy-naïve. Group B will enroll eligible patients who have progressed after prior first- or second-generation EGFR TKI, regardless of T790M mutation status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Rociletinib and MPDL3280A | Experimental | Drug: Rociletinib, Drug: MPDL3280ASpecific doses of rociletinib, taken continuously BID, will be administered in combination with a fixed dose of MPDL3280A, given intravenously on Day 1 of each 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ECOG performance status of 0 or 1
- Adequate hematological and biological function, confirmed by defined laboratory values
- Histologically or cytologically documented metastatic or unresectable, locally advanced or metastatic NSCLC, with one or more activating EGFR mutation (eg, G719X, exon 19 deletion, L858R, L861Q) and absence of exon 20 insertion
- Measurable disease as defined by RECIST v1.1
- Biopsy of tumor tissue for central evaluation, within 60 days prior to the first day of study treatment
Key exclusion criteria (17 listed)
- Unresolved toxicities from prior therapy
- Symptomatic, untreated or unstable central nervous system or leptomeningeal metastases
- Previous treatment with rociletinib or MPDL3280A, or other 3rd generation EGFR TKI (eg, AZD-9291, HM61713), or PD 1 axis targeted therapy (eg, anti PD 1 or anti-PD L1)
- Prior treatment with CD137 agonists or other immune checkpoint blockade therapies, including anti-CTLA-4 therapeutic antibodies
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures
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 |
|---|---|---|
| RociletinibAlso: CO-1686A novel, potent, covalent (irreversible) small molecule, tyrosine kinase inhibitor (TKI) administered orally (PO) to patients with EGFRm NSCLC. | Drug | Single Arm Rociletinib and MPDL3280A |
| MPDL3280AAlso: atezolizumabA human IgG1 monoclonal antibody administered intravenously (IV) | Drug | Single Arm Rociletinib and MPDL3280A |
Primary outcome
Number of Treatment-emergent Adverse Events, as Assessed by NCI CTCAE v4.03
Time frame: Continuously, up to approximately 18.5 months
The safety analyses will be performed using the safety population. Safety data analysis will be conducted on all patients receiving at least one dose of rociletinib or MPDL3280A.
Maximum Concentration (Cmax) of Rociletinib and Its Metabolites
Time frame: Treatment Day 1 and Day 15
Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmax will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.
Time to Maximum Concentration (Tmax) for Rociletinib and Rociletinib Metabolites
Time frame: Treatment Day 1 and Day 15
Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Tmax will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.
Minimum Concentration (Cmin) of Rociletinib and Metabolites
Time frame: Approximately every 6 weeks up to 24 months
Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmin will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.
Area Under the Curve (AUC) of Rociletinib and Rociletinib Metabolites
Time frame: Treatment Day 1 and Day 8
Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. AUC0 24 will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.
Maximum Concentration (Cmax) of MPDL3280A
Time frame: Cycle 1 Day 1
Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmax, for MPDL3280A will be assessed using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.
Minimum Concentration (Cmin) of MPDL3280A
Time frame: Approximately every 6 weeks up to 24 months
Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmin for MPDL3280A will be assessed using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.
Objective Response Rate Per RECIST v1.1 in Phase 2
Time frame: Approximately every 6-9 weeks
To determine the efficacy of the combination of rociletinib and MPDL3280A based on overall response rate per RECIST v1.1 in the following groups of patients: * Group A: Patients with EGFRm advanced or metastatic NSCLC who have not previously received an EGFR TKI or chemotherapy. * Group B: Patients with EGFRm advanced or metastatic NSCLC who have progressed on a prior EGFR TKI.
5 secondary outcomes
Objective Response Rate Per Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2
Time frame: Approximately every 6-9 weeks, up to 24 months
Duration of Response Per RECIST v1.1 and Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2
Time frame: Approximately every 6-9 weeks, up to 24 months
Progression-free Survival Per RECIST v1.1 and Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2
Time frame: Approximately every 6-9 weeks, up to 24 months
Number of Patients Alive at Study Termination
Time frame: Up to approximately 18.5 months
Longitudinal Changes in Blood Based Biomarkers (eg, Mutations in EGFR) in ctDNA
Time frame: Blood samples will be collected from each patient approximately every 3 weeks, up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lindsey Rolfe, MD study director
Clovis Oncology, Inc.
1 site 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 Rociletinib and MPDL3280A in people with Non-small Cell Lung Cancer, run by Clovis Oncology, Inc. 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 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 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 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 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 5 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?
Number of Treatment-emergent Adverse Events, as Assessed by NCI CTCAE v4.03 (time frame: Continuously, up to approximately 18.5 months). The study lists 8 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 5 Jul 2019.