Non-Small Cell Lung CancerPhase 1NCT03101839
Phase I Dose-Escalation Study of AZD4785 in Patients With Advanced Solid Tumours
A Phase 1 study testing AZD4785 in people with Non-Small Cell Lung Cancer and Advanced Solid Tumours, run by AstraZeneca at 5 sites in 2 countries.
Trial summary
A Phase I, open-label, multicentre, dose-escalation study to investigate the safety, pharmacokinetics and maximum tolerated dose (MTD) of AZD4785 in patients with advanced solid tumours where KRAS may be an important driver of tumour survival. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Advanced Solid Tumours
- What is being tested?
- AZD4785
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 May 2017to 8 Jan 2019
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part A Dose Escalation: Patients must have histological or cytological confirmation of a solid tumour known to harbour KRAS mutations (e.g., NSCLC, mCRC, pancreatic or cholangiocarcinoma), and have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumour for which no standard therapy(ies) exists.
- Part B Expansion: Patients in Part B must have measurable disease as measured by Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1
- Group 1. Patients must have histological or cytological confirmation of locally advanced or metastatic KRASm+ NSCLC, who have failed prior therapy and for whom no current therapy is available.
- Group 2. Patients must have histological or cytological confirmation of locally advanced or metastatic KRASm+ NSCLC, who have failed prior therapy and for whom no current therapy is available. At study entry patients must be clinically suitable for mandatory baseline and on-treatment tumour biopsies.
- Signed written informed consent
- ≥ 18 years old
Show all 24Show fewer
- All patients must have an activating KRAS mutation in tumour tissue samples from a prior test conducted by a clinical laboratory that has received international or country specific certification. Patients in Part B dosed on the basis of the local identification of an activating KRAS mutation, and whose KRAS mutation is not confirmed by the central laboratory (with the exception of locally obtained KRAS mutation status obtained from the approved tests), will remain on study but may be excluded from pharmacodynamic and anti-tumour activity analyses and replaced at the Sponsor's discretion. KRAS mutations identified in ctDNA (circulating tumour DNA) from blood are not acceptable; only mutations identified from tumour tissue are acceptable. Activating mutations may include but are not limited to:
- NSCLC KRAS mutations in codons G12/13, Q61, and A59
- mCRC KRAS mutations in codons G12/13 (Exon 2), Q61, A59 (Exon 3), K117, and A146 (Exon 4)
- Patient must agree to the collection of archival tumour tissue sample for biomarker analysis. If an archived tumour sample is not available a fresh tumour biopsy can be used.
- Adequate organ system function as indicated by:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Haemoglobin ≥ 9g/dL
- Activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 times the ULN if no liver involvement or ≤ 5 times the ULN with liver involvement.
- Creatinine ≤ 1.5 times the ULN or creatinine clearance ≥ 60 mL/min as calculated by the Cockcroft-Gault method, or 24 hour measured urine creatinine clearance ≥ 60 mL/min.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy ≥ 12 weeks
- Male patients with female partners of child-bearing potential must be willing to use one highly effective form of contraception and must use a condom during their participation in this study and for 7 months following the last dose of the study drug. Male patients must refrain from donating sperm during their participation in the study and at least for 7 months after the last treatment.
- Female patients must use a highly effective contraceptive measure from screening until 18 weeks after the last dose of drug. All methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by a male sexual partner for intercourse. Female patients should not be breast-feeding and must have a negative pregnancy test prior to start of dosing if of childbearing potential or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:
- Post-menopausal women defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatment.
- Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation.
Who cannot join
- Patients who have received chemotherapy, radiotherapy, hormonal therapy, immunotherapy or investigational drugs within 21 days or 5 half lives (whichever is shorter) from enrolment.
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of enrolment.
- Unresolved immunotherapy-related hepatotoxicity from previous therapy.
- Major surgery (excluding placement of vascular access) ≤ 21 days from beginning of the enrolment or minor surgical procedures ≤ 7 days. No waiting is required following implantable port and catheter placement.
- Patients receiving full-dose anti-coagulation therapies.
- Has active or prior documented autoimmune disease within the past 2 years with the exception of vitiligo, Grave's disease, and/or psoriasis not requiring systemic treatment.
Show all 18Show fewer
- Has a history of atypical Haemolytic Uremic Syndrome.
- Patients with leptomeningeal metastases.
- Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 3 weeks prior to enrolment and there is no evidence of central nervous system disease progression or mild neurologic symptoms, and no requirement for chronic corticosteroid therapy.
- Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- Any of the following cardiac criteria:
- Congestive heart failure (CHF) per New York Heart Association (NYHA) classification > Class II.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Unstable angina or new-onset angina.
- QT interval (QTcF) >470 ms on screening electrocardiogram (ECG) by Fridericia's formula.
- History of hypersensitivity to active or inactive excipients of AZD4785 or drugs with a similar chemical structure or class to AZD4785.
- Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Research Site
Boston, Massachusetts, 02215
Research Site
Nashville, Tennessee, 37203
Research Site
Sarasota, Florida, 34232
United Kingdom2 sites
Research Site
London, W1G 6AD
Research Site
Manchester, M20 4BX
About this study
Official title: A Phase I, Open-Label, Multicentre Dose-Escalation Study to Investigate the Safety and Pharmacokinetics of AZD4785 in Patients With Advanced Solid Tumours Where KRAS May Be an Important Driver of Tumour Survival
A Phase I, open-label, multicentre, dose-escalation study to investigate the safety, pharmacokinetics and maximum tolerated dose (MTD) of AZD4785 in patients with advanced solid tumours where KRAS may be an important driver of tumour survival.
Part A: Dose escalation in patients with solid tumours to evaluate safety, pharmacokinetics and maximum tolerated dose (MTD). Once the maximum tolerated dose (MTD) is established, a dose expansion cohort may be included in Part A, with up to an additional 6 patients to further explore the PK, safety, tolerability, and preliminary anti-tumour activity of the AZD4785 MTD for confirmation of the recommended phase 2 dose (RP2D).
Part B: Expansion cohort at the selected dose in patients with non-small cell lung cancer (NSCLC) to evaluate PK parameters, safety, tolerability, and preliminary anti-tumour activity of the AZD4785 RP2D as monotherapy in patients with NSCLC. Approximately 20 patients with NSCLC (Two groups of approximately 10 patients each) with NSCLC will be enrolled to Part B. Group 1 patients will have an option to provide tumour biopsies and Group 2 will be required (mandatory) to provide paired tumour biopsies. Overall up to 12 patients in Group 2Part B patients will be required (mandatory) to may provide paired tumour biopsies. A third group of up to 20 patients with other tumour types and/or a potential different schedule may be added based on the results seen in Parts A and B and any other emerging data and may also provide biopsies.
Read the detailed description
This is a First-Time-in-Human (FTIH), Phase 1 study to determine the MTD, recommended Phase 2 dose (RP2D), safety, tolerability, pharmacodynamics, and pharmacokinetics of AZD4785. The study will be conducted in two parts: a dose-escalation phase (Part A)and an expansion phase (Part B). A third group of up to 20 patients with other tumour types and/or a potential different schedule may be added based on the results seen in Parts A and B and any other emerging data.
AZD4785 will be given as an IV infusion over 1 hour, initially in 3 loading doses during the first week and then weekly thereafter. The loading doses will be given on Days 1, 3, and 5 of the first week and weekly thereafter on Days 8, 15, and 22 of 28 Day cycles. In subsequent cycles AZD4785 will be administered on Days 1, 8, 15, and 22 until disease progression, intolerable toxicity, or discontinuation criteria have been met.
Once the MTD is established, a dose expansion cohort may be included in Part A, with up to 6 additional patients to explore the PK, safety, tolerability, and preliminary anti-tumour activity of the AZD4785 MTD for confirmation of the RP2D. Thereafter, Part B expansion phase will continue to explore PK parameters, safety, tolerability, and preliminary anti-tumour activity of the AZD4785 RP2D as monotherapy in patients with NSCLC. Approximately 20 patients with NSCLC (2 groups of approximately 10 patients each) with NSCLC will be enrolled to Part B. Group 1 patients will have an option to provide tumour biopsies and Group 2 will be required (mandatory) to provide paired tumour biopsies. Overall up to 12 patients in Part B may provide paired tumour biopsies. A third group of up to 20 patients with other tumour types and/or a potential different schedule may be added based on the results seen in Parts A and B and any other emerging data and may also provide biopsies. Up to 12 patients in Part B may provide paired biopsies.
- Conditions
- Non-Small Cell Lung Cancer, Advanced Solid Tumours
- Being tested
- AZD4785
- Keywords
- AZD4785, KRAS, KRAS mutations, Non-small cell lung cancer, Advanced solid tumours
- 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.
AZD4785Drug
KRAS Antisense Oligonucleotide
| Study group | Role | What they receive |
|---|---|---|
| AZD4785 | Experimental | This is a single-arm study in which all patients will receive AZD4785 by IV infusion. Patients will continue to receive treatment with AZD4785 until disease progression, intolerable toxicity, or discontinuation criteria are met. Receives: Drug: AZD4785 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Determined through the evaluation of dose-limiting toxicity (DLT), adverse events, clinical laboratory test results, clinical evaluation and patient reported symptoms
Measured: Minimum of 28 days for a patient
Secondary outcomes (4)
Peak plasma concentration (Cmax) of AZD4785
The concentration of AZD4785 in plasma, including peak concentration (Cmax), will be determined.
Measured: Samples for determination of AZD4785 plasma conc. will be collected at multiple times on Day 1 Cycle 1, pre-dose on Days 3, 5, and 8 of Cycle 1, Day 22 of Cycle 2, and Day 1 of Cycles 3 and 4. Time points may be adjusted based on emerging data.
Area under the plasma concentration versus time curve (AUC) for AZD4785
The concentration of AZD4785 in plasma, including area under the plasma concentration versus time curve (AUC), will be determined.
Measured: Samples for determination of AZD4785 plasma conc. will be collected at multiple times on Day 1 Cycle 1, pre-dose on Days 3, 5, and 8 of Cycle 1, Day 22 of Cycle 2, and Day 1 of Cycles 3 and 4. Time points may be adjusted based on emerging data.
Objective Clinical Response
CT scan to measure tumour
Measured: Every 8 weeks up to 12 months.
KRAS messenger RNA (mRNA)
Change from baseline in KRAS mRNA following treatment.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start15 May 2017
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hendrik-Tobias Arkenau, MD, Principal investigator, Sarah Cannon Research Institute United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101839
- Sponsor's protocol ID
- D8360C00001
- Other IDs
- REFMAL 484
- Status last verified
- Sep 2019
- First submitted
- 22 Mar 2017
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multicentre Dose-Escalation Study to Investigate the Safety and Pharmacokinetics of AZD4785 in Patients With Advanced Solid Tumours Where KRAS May Be an Important Driver of Tumour Survival
- ClinicalTrials.gov ID
- NCT03101839
- Acronym / sponsor ID
- D8360C00001
- Conditions
- Non-Small Cell Lung Cancer, Advanced Solid Tumours
- Keywords
- AZD4785, KRAS, KRAS mutations, Non-small cell lung cancer, Advanced solid tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 May 2017 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 5 Apr 2017 (actual)
- 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.
A Phase I, open-label, multicentre, dose-escalation study to investigate the safety, pharmacokinetics and maximum tolerated dose (MTD) of AZD4785 in patients with advanced solid tumours where KRAS may be an important driver of tumour survival.
Part A: Dose escalation in patients with solid tumours to evaluate safety, pharmacokinetics and maximum tolerated dose (MTD). Once the maximum tolerated dose (MTD) is established, a dose expansion cohort may be included in Part A, with up to an additional 6 patients to further explore the PK, safety, tolerability, and preliminary anti-tumour activity of the AZD4785 MTD for confirmation of the recommended phase 2 dose (RP2D).
Part B: Expansion cohort at the selected dose in patients with non-small cell lung cancer (NSCLC) to evaluate PK parameters, safety, tolerability, and preliminary anti-tumour activity of the AZD4785 RP2D as monotherapy in patients with NSCLC. Approximately 20 patients with NSCLC (Two groups of approximately 10 patients each) with NSCLC will be enrolled to Part B. Group 1 patients will have an option to provide tumour biopsies and Group 2 will be required (mandatory) to provide paired tumour biopsies. Overall up to 12 patients in Group 2Part B patients will be required (mandatory) to may provide paired tumour biopsies. A third group of up to 20 patients with other tumour types and/or a potential different schedule may be added based on the results seen in Parts A and B and any other emerging data and may also provide biopsies.
Detailed description
This is a First-Time-in-Human (FTIH), Phase 1 study to determine the MTD, recommended Phase 2 dose (RP2D), safety, tolerability, pharmacodynamics, and pharmacokinetics of AZD4785. The study will be conducted in two parts: a dose-escalation phase (Part A)and an expansion phase (Part B). A third group of up to 20 patients with other tumour types and/or a potential different schedule may be added based on the results seen in Parts A and B and any other emerging data.
AZD4785 will be given as an IV infusion over 1 hour, initially in 3 loading doses during the first week and then weekly thereafter. The loading doses will be given on Days 1, 3, and 5 of the first week and weekly thereafter on Days 8, 15, and 22 of 28 Day cycles. In subsequent cycles AZD4785 will be administered on Days 1, 8, 15, and 22 until disease progression, intolerable toxicity, or discontinuation criteria have been met.
Once the MTD is established, a dose expansion cohort may be included in Part A, with up to 6 additional patients to explore the PK, safety, tolerability, and preliminary anti-tumour activity of the AZD4785 MTD for confirmation of the RP2D. Thereafter, Part B expansion phase will continue to explore PK parameters, safety, tolerability, and preliminary anti-tumour activity of the AZD4785 RP2D as monotherapy in patients with NSCLC. Approximately 20 patients with NSCLC (2 groups of approximately 10 patients each) with NSCLC will be enrolled to Part B. Group 1 patients will have an option to provide tumour biopsies and Group 2 will be required (mandatory) to provide paired tumour biopsies. Overall up to 12 patients in Part B may provide paired tumour biopsies. A third group of up to 20 patients with other tumour types and/or a potential different schedule may be added based on the results seen in Parts A and B and any other emerging data and may also provide biopsies. Up to 12 patients in Part B may provide paired biopsies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD4785 | Experimental | Drug: AZD4785This is a single-arm study in which all patients will receive AZD4785 by IV infusion. Patients will continue to receive treatment with AZD4785 until disease progression, intolerable toxicity, or discontinuation criteria are met. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Part A Dose Escalation: Patients must have histological or cytological confirmation of a solid tumour known to harbour KRAS mutations (e.g., NSCLC, mCRC, pancreatic or cholangiocarcinoma), and have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumour for which no standard therapy(ies) exists.
- Part B Expansion: Patients in Part B must have measurable disease as measured by Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1
- Group 1. Patients must have histological or cytological confirmation of locally advanced or metastatic KRASm+ NSCLC, who have failed prior therapy and for whom no current therapy is available.
- Group 2. Patients must have histological or cytological confirmation of locally advanced or metastatic KRASm+ NSCLC, who have failed prior therapy and for whom no current therapy is available. At study entry patients must be clinically suitable for mandatory baseline and on-treatment tumour biopsies.
- Signed written informed consent
Key exclusion criteria (18 listed)
- Patients who have received chemotherapy, radiotherapy, hormonal therapy, immunotherapy or investigational drugs within 21 days or 5 half lives (whichever is shorter) from enrolment.
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of enrolment.
- Unresolved immunotherapy-related hepatotoxicity from previous therapy.
- Major surgery (excluding placement of vascular access) ≤ 21 days from beginning of the enrolment or minor surgical procedures ≤ 7 days. No waiting is required following implantable port and catheter placement.
- Patients receiving full-dose anti-coagulation therapies.
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 |
|---|---|---|
| AZD4785KRAS Antisense Oligonucleotide | Drug | AZD4785 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Minimum of 28 days for a patient
Determined through the evaluation of dose-limiting toxicity (DLT), adverse events, clinical laboratory test results, clinical evaluation and patient reported symptoms
4 secondary outcomes
Peak plasma concentration (Cmax) of AZD4785
Time frame: Samples for determination of AZD4785 plasma conc. will be collected at multiple times on Day 1 Cycle 1, pre-dose on Days 3, 5, and 8 of Cycle 1, Day 22 of Cycle 2, and Day 1 of Cycles 3 and 4. Time points may be adjusted based on emerging data.
Area under the plasma concentration versus time curve (AUC) for AZD4785
Time frame: Samples for determination of AZD4785 plasma conc. will be collected at multiple times on Day 1 Cycle 1, pre-dose on Days 3, 5, and 8 of Cycle 1, Day 22 of Cycle 2, and Day 1 of Cycles 3 and 4. Time points may be adjusted based on emerging data.
Objective Clinical Response
Time frame: Every 8 weeks up to 12 months.
KRAS messenger RNA (mRNA)
Time frame: 1-3 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 4 Oct 2019.
- Results of this clinical trial are available on www.astrazenecaclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Hendrik-Tobias Arkenau, MD principal investigator
Sarah Cannon Research Institute United Kingdom
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD4785 in people with Non-Small Cell Lung Cancer and Advanced Solid Tumours, run by AstraZeneca at 5 sites in 2 countries.
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 24 inclusion and 18 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 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, United Kingdom. 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?
Maximum tolerated dose (MTD) (time frame: Minimum of 28 days for a patient). 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 4 Oct 2019.