Advanced Solid TumorsPhase 1NCT02546531
Defactinib Combined With Pembrolizumab and Gemcitabine in Patients With Advanced Cancer
A Phase 1 study testing Defactinib, Pembrolizumab and Gemcitabine in people with Advanced Solid Tumors and Solid Tumors, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
In pancreatic cancer, targeting the tumor microenvironment has become a promising therapeutic strategy. Focal adhesion kinase (FAK) pathway activation is essential for promoting a fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have demonstrated reasonable anti-tumor activity in the preclinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Solid Tumors, Pancreatic Cancer
- What is being tested?
- Defactinib, Pembrolizumab and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Feb 2016to 11 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Dose escalation cohort: Histologically or cytologically confirmed diagnosis of advanced solid tumor for which standard curative or palliative measures do not exist or are no longer effective.
- Expansion cohort: Histologically or cytologically confirmed diagnosis of advanced pancreatic cancer.
- Maintenance group (n=10): Patients must be stable on front-line therapy (defined as at least 4 months stable disease on nab-paclitaxel + gemcitabine)
- Second-line group (n=10): Patients must have failed or could not tolerate the front line of 5FU-based therapy for advanced pancreatic cancer at least one line of chemotherapy indicated for advanced pancreatic cancer
- Expansion cohort: There should be a 2 to 4 week break between the patient's last dose of standard chemotherapy to initiation of the first cycle of study drugs. Longer than 4-week break may be permitted at the discretion of the PI.
- Expansion cohort: No more than one line of prior systemic therapy for advanced pancreatic adenocarcinoma allowed
Show all 22Show fewer
- Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan or MRI, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
- At least 18 years of age.
- ECOG performance status ≤ 1
- Life expectancy > 3 months
- Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN, or ≤ 5.0 x IULN if due to liver involvement by tumor
- Creatinine ≤ 1.5 x IULN or glomerular filtration rate of ≥ 60 mL/min
- INR ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or PTT is within therapeutic range of intended use of anticoagulants
- aPTT ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or PTT is within therapeutic range of intended use of anticoagulants
- Corrected QT interval (QTc) < 480 ms (as calculated by the Fridericia correction formula).
- Women of childbearing potential and men must agree to use adequate contraceptive methods prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- A history of other malignancy ≤ 2 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- No clinically evident ascites that requires therapeutic paracentesis.
- At risk of bowel perforation
- Prior treatment with a drug of the FAK inhibitor class or with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Prior treatment with systemic gemcitabine less than 6 months
- Currently receiving any other investigational agents
Show all 20Show fewer
- Known brain metastases. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to defactinib, pembrolizumab, gemcitabine, or other agents used in the study.
- Received a live vaccine within 30 days prior to the first study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab.
- Has an active autoimmune disease requiring systemic treatment within the past 2 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Patients with hypothyroidisms stable on hormone replacement or Sjorgen's syndrome would not e excluded from the study.
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Major surgery within 28 days prior to the first study treatment.
- History or evidence of cardiac risk including any of the following: history or evidence of current clinically significant uncontrolled arrhythmias or arrhythmia requiring treatment with the exceptions of atrial fibrillation and paroxysmal supraventricular tachycardia; history of acute coronary syndromes within 6 months prior to the first dose of study therapy (including myocardial infarction and unstable angina, coronary angioplasty, or stenting); or any history of congestive heart failure with most recent ejection fraction < 45% (screening LVEF assessment without history of CHF is not required).
- Known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected)
- Requires continued use of warfarin for anticoagulation and cannot stop warfarin or be safely switched to another anticoagulant
- Gastrointestinal condition that could interfere with the swallowing or absorption of study medication.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, immunosuppression, autoimmune conditions, underlying pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with pembrolizumab and/or defactinib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Phase I Study of Defactinib Combined With Pembrolizumab and Gemcitabine in Patients With Advanced Cancer
In pancreatic cancer, targeting the tumor microenvironment has become a promising therapeutic strategy. Focal adhesion kinase (FAK) pathway activation is essential for promoting a fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have demonstrated reasonable anti-tumor activity in the preclinical setting. Furthermore, a maximal synergetic effect was achieved when a FAK inhibitor was given in combination with a PD-1 antagonist and chemotherapy in multiple pancreas tumor animal models. This supports the concept of using FAK inhibitors to reduce stromal fibrosis during checkpoint immunotherapeutic treatment. Therefore, these robust preclinical findings will be tested in the proposed phase I trial.
- Conditions
- Advanced Solid Tumors, Solid Tumors, Pancreatic Cancer
- Being tested
- Defactinib, Pembrolizumab, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DefactinibBiological
Also called VS-6063
PembrolizumabBiological
Also called Keytruda, MK-3475
GemcitabineDrug
Also called Gemzar
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation (defactinib, pembrolizumab, gemcitabine) | Experimental | * Defactinib is an oral drug which will be administered on an outpatient basis at the prescribed dose twice a day daily during each 21-day cycle.
* Pembrolizumab is an intravenous (IV) drug which will be administered on an outpatient basis over 30 minutes (-5/+10) at a dose of 200 mg on Day 1 of each 21-day cycle.
* Gemcitabine is an IV drug which will be administered on an outpatient basis over 30 minutes at the prescribed dose on Days 1 and 8 of each 21-day cycle.
* Participants enrolled in Dose Level 1 and 2 will not receive gemcitabine. Receives: Biological: Defactinib; Biological: Pembrolizumab; Drug: Gemcitabine |
| Dose expansion (defactinib, pembrolizumab, gemcitabine) | Experimental | * Defactinib is an oral drug which will be administered on an outpatient basis at the prescribed dose twice a day daily during each 21-day cycle.
* Pembrolizumab is an intravenous (IV) drug which will be administered on an outpatient basis over 30 minutes (-5/+10) at a dose of 200 mg on Day 1 of each 21-day cycle.
* Gemcitabine is an IV drug which will be administered on an outpatient basis over 30 minutes at the prescribed dose on Days 1 and 8 of each 21-day cycle.
* Participants enrolled in Dose Level 1 and 2 will not receive gemcitabine. Receives: Biological: Defactinib; Biological: Pembrolizumab; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase II dose
- The recommended phase II dose will be determined from the maximum tolerated dose (MTD) found in the dose escalation cohort.
- The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle (21 days). Dose escalations will proceed until the MTD has been reached or the completion of cycle 5.
Measured: Completion of the first cycle of all patients enrolled (approximately 25 months)
Secondary outcomes (11)
Safety and toxicity as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Measured: 30 days after completion of treatment (estimated average of 7 months)
Objective response rate (ORR) in dose escalation cohort
- The definition of ORR is the proportion of patients who achieved a complete response or a partial response
- The definition of complete response (CR) is the disappearance of all target lesions, non-target lesions, and no new lesions
- The definition of partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions and no new lesions
Measured: Up to 2 years after completion of treatment (estimated average to be 36 months)
Objective response rate (ORR) in dose expansion cohort
- The definition of ORR is the proportion of patients who achieved a complete response or a partial response
- The definition of complete response (CR) is the disappearance of all target lesions, non-target lesions, and no new lesions
- The definition of partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions and no new lesions
Measured: Up to 2 years after completion of treatment (estimated average to be 36 months)
Treatment duration in dose escalation cohort
Measured: Completion of treatment (estimated average of 6 months)
Treatment duration in dose expansion cohort
Measured: Completion of treatment (estimated average of 6 months)
Progression-free survival (PFS) in dose escalation cohort
- PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
- Progressive disease - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, appearance of one more new lesions
Measured: Up to 2 years after completion of treatment (estimated average to be 36 months)
Progression-free survival in dose expansion cohort
- PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
- Progressive disease - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, appearance of one more new lesions
Measured: Up to 2 years after completion of treatment (estimated average to be 36 months)
Overall survival (OS) in dose escalation cohort
-OS: duration of time from start of treatment to time of death from any cause
Measured: Up to 2 years after completion of treatment (estimated average to be 36 months)
Overall survival in dose expansion cohort
-OS: duration of time from start of treatment to time of death from any cause
Measured: Up to 2 years after completion of treatment (estimated average to be 36 months)
Immune-related PFS in dose escalation cohort
Measured: Up to 2 years after completion of treatment (estimated average to be 36 months)
Immune-related PFS in dose expansion cohort
Measured: Up to 2 years after completion of treatment (estimated average to be 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start3 Feb 2016
- Primary completion17 Nov 2017
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital, Merck Sharp & Dohme LLC, Verastem, Inc.
- Responsible party
- Sponsor
- Investigators
- Kian-Huat Lim, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546531
- Sponsor's protocol ID
- 201510157
- Status last verified
- Jul 2021
- First submitted
- 14 Aug 2015
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fard D, Giraudo E, Tamagnone L. Mind the (guidance) signals! Translational relevance of semaphorins, plexins, and neuropilins in pancreatic cancer. Trends Mol Med. 2023 Oct;29(10):817-829. doi: 10.1016/j.molmed.2023.07.009. Epub 2023 Aug 17.
PubMed 37598000
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Defactinib Combined With Pembrolizumab and Gemcitabine in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT02546531
- Acronym / sponsor ID
- 201510157
- Conditions
- Advanced Solid Tumors, Solid Tumors, Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital, Merck Sharp & Dohme LLC, Verastem, Inc.
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In pancreatic cancer, targeting the tumor microenvironment has become a promising therapeutic strategy. Focal adhesion kinase (FAK) pathway activation is essential for promoting a fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have demonstrated reasonable anti-tumor activity in the preclinical setting. Furthermore, a maximal synergetic effect was achieved when a FAK inhibitor was given in combination with a PD-1 antagonist and chemotherapy in multiple pancreas tumor animal models. This supports the concept of using FAK inhibitors to reduce stromal fibrosis during checkpoint immunotherapeutic treatment. Therefore, these robust preclinical findings will be tested in the proposed phase I trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation (defactinib, pembrolizumab, gemcitabine) | Experimental | Biological: Defactinib, Biological: Pembrolizumab, Drug: Gemcitabine* Defactinib is an oral drug which will be administered on an outpatient basis at the prescribed dose twice a day daily during each 21-day cycle. * Pembrolizumab is an intravenous (IV) drug which will be administered on an outpatient basis over 30 minutes (-5/+10) at a dose of 200 mg on Day 1 of each 21-day cycle. * Gemcitabine is an IV drug which will be administered on an outpatient basis over 30 minutes at the prescribed dose on Days 1 and 8 of each 21-day cycle. * Participants enrolled in Dose Level 1 and 2 will not receive gemcitabine. |
| Dose expansion (defactinib, pembrolizumab, gemcitabine) | Experimental | Biological: Defactinib, Biological: Pembrolizumab, Drug: Gemcitabine* Defactinib is an oral drug which will be administered on an outpatient basis at the prescribed dose twice a day daily during each 21-day cycle. * Pembrolizumab is an intravenous (IV) drug which will be administered on an outpatient basis over 30 minutes (-5/+10) at a dose of 200 mg on Day 1 of each 21-day cycle. * Gemcitabine is an IV drug which will be administered on an outpatient basis over 30 minutes at the prescribed dose on Days 1 and 8 of each 21-day cycle. * Participants enrolled in Dose Level 1 and 2 will not receive gemcitabine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Dose escalation cohort: Histologically or cytologically confirmed diagnosis of advanced solid tumor for which standard curative or palliative measures do not exist or are no longer effective.
- Expansion cohort: Histologically or cytologically confirmed diagnosis of advanced pancreatic cancer.
- Expansion cohort: There should be a 2 to 4 week break between the patient's last dose of standard chemotherapy to initiation of the first cycle of study drugs. Longer than 4-week break may be permitted at the discretion of the PI.
- Expansion cohort: No more than one line of prior systemic therapy for advanced pancreatic adenocarcinoma allowed
- Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan or MRI, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
Key exclusion criteria (20 listed)
- A history of other malignancy ≤ 2 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- No clinically evident ascites that requires therapeutic paracentesis.
- At risk of bowel perforation
- Prior treatment with a drug of the FAK inhibitor class or with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Prior treatment with systemic gemcitabine less than 6 months
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 |
|---|---|---|
| DefactinibAlso: VS-6063 | Biological | Dose escalation (defactinib, pembrolizumab, gemcitabine), Dose expansion (defactinib, pembrolizumab, gemcitabine) |
| PembrolizumabAlso: Keytruda, MK-3475 | Biological | Dose escalation (defactinib, pembrolizumab, gemcitabine), Dose expansion (defactinib, pembrolizumab, gemcitabine) |
| GemcitabineAlso: Gemzar | Drug | Dose escalation (defactinib, pembrolizumab, gemcitabine), Dose expansion (defactinib, pembrolizumab, gemcitabine) |
Primary outcome
Recommended phase II dose
Time frame: Completion of the first cycle of all patients enrolled (approximately 25 months)
* The recommended phase II dose will be determined from the maximum tolerated dose (MTD) found in the dose escalation cohort. * The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle (21 days). Dose escalations will proceed until the MTD has been reached or the completion of cycle 5.
11 secondary outcomes
Safety and toxicity as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time frame: 30 days after completion of treatment (estimated average of 7 months)
Objective response rate (ORR) in dose escalation cohort
Time frame: Up to 2 years after completion of treatment (estimated average to be 36 months)
Objective response rate (ORR) in dose expansion cohort
Time frame: Up to 2 years after completion of treatment (estimated average to be 36 months)
Treatment duration in dose escalation cohort
Time frame: Completion of treatment (estimated average of 6 months)
Treatment duration in dose expansion cohort
Time frame: Completion of treatment (estimated average of 6 months)
Progression-free survival (PFS) in dose escalation cohort
Time frame: Up to 2 years after completion of treatment (estimated average to be 36 months)
Progression-free survival in dose expansion cohort
Time frame: Up to 2 years after completion of treatment (estimated average to be 36 months)
Overall survival (OS) in dose escalation cohort
Time frame: Up to 2 years after completion of treatment (estimated average to be 36 months)
Overall survival in dose expansion cohort
Time frame: Up to 2 years after completion of treatment (estimated average to be 36 months)
Immune-related PFS in dose escalation cohort
Time frame: Up to 2 years after completion of treatment (estimated average to be 36 months)
Immune-related PFS in dose expansion cohort
Time frame: Up to 2 years after completion of treatment (estimated average to be 36 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Derived from this study: PubMed 37598000Fard D, Giraudo E, Tamagnone L. Mind the (guidance) signals! Translational relevance of semaphorins, plexins, and neuropilins in pancreatic cancer. Trends Mol Med. 2023 Oct;29(10):817-829. doi: 10.1016/j.molmed.2023.07.009. Epub 2023 Aug 17.
- 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.
Kian-Huat Lim, M.D., Ph.D. principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Defactinib, Pembrolizumab and Gemcitabine in people with Advanced Solid Tumors and Solid Tumors, run by Washington University School of Medicine at 2 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 22 inclusion and 20 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 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recommended phase II dose (time frame: Completion of the first cycle of all patients enrolled (approximately 25 months)). 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 NCT02546531, 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 20 Jul 2021.