Advanced Solid Tumours With Androgen Receptor Pathway as a Potential FactorPhase 1NCT02144051

Phase I Open Label Dose Escalation Study to Investigate the Safety & Pharmacokinetics of AZD5312 in Patients With Androgen Receptor Tumors

A Phase 1 study testing AZD5312 in people with Advanced Solid Tumours With Androgen Receptor Pathway as a Potential Factor, run by AstraZeneca at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a first time in man (FTIM), Phase I study to determine the Maximum Tolerated Dose, Recommended Phase 2 Dose, safety, tolerability and Pharmacokinetics of AZD5312. This is a multicentre study with sites in the United States and United Kingdom. Approximately 90 patients are expected to be enrolled in this study. Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Advanced Solid Tumours With Androgen Receptor Pathway as a Potential Factor
What is being tested?: AZD5312
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 4 sitesin 2 countries
Study dates: May 2014to Mar 2016
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

Patient must understand nature of trial and provide a signed and dated, written informed consent form prior to study specific procedures, sampling and analyses. If a patient declines to participate in voluntary exploratory research and/or genetic component of study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other aspects of the study.
Part A Dose Escalation Patients must have histological or cytological confirmation of a solid tumour of either locally advanced or metastatic castrate resistant prostate cancer (mCRPC), breast, bladder, ovarian, gastric or salivary duct carcinoma where an Androgen Receptor pathway may be a potential factor.
Part B Dose Expansion.
Patient must understand nature of trial and provide a signed and dated, written informed consent form prior to any study specific procedures, sampling and analyses.
Part A Dose Escalation Patients must have histological or cytological confirmation of a solid tumour of either locally advanced or metastatic castrate resistant prostate cancer (mCRPC), breast, bladder, ovarian, gastric or salivary duct carcinoma where an Androgen Receptor pathway may be a potential factor.
Part B Dose Expansion Arm 1 and 2 patients must have histological or cytological confirmation of locally advanced or metastatic castrate resistant prostate cancer who have progressive disease at the time of entry demonstrated either by Response Evaluation Criteria in Solid Tumors (RECIST) (measurable disease) or by two subsequently increasing Prostate-specific antigen (PSA) values obtained at least one week apart. Arm 3 will include non-mCRPC patients. The patient populations in the dose expansion phase will be as follows:

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Arm 1 Prostate cancer patients with prior second generation anti-hormonal therapy (examples: abiraterone, enzalutamide, TAK 700) without response (disease progression in ≤4 months or Stable Disease (SD) but Prostate-specific antigen (PSA) level did not decline ≥50%).
Arm 2 Prostate cancer patients with intial response to second generation anti-hormonal therapy (examples: abiraterone, enzalutamide, TAK 700), but later relapsed. Disease relapse would be defined as progressive disease at the time of entry demonstrated either by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (measurable disease) or by two subsequently increasing Prostate-specific antigen (PSA) values obtained at least one week apart. If clinically meaningful benefits have been identified in a non-mCRPC patient population during the escalation phase, a potential third expansion arm may be considered.
Arm 3 Patients with a non-mCRPC type solid tumour such as locally advanced or metastatic breast, bladder, ovarian, gastric or salivary duct carcinomas.
Aged at least 18 years
Adequate organ system functions, as outined below - Absolute neutrophil count (ANC) ≥1.5 X109/L - Platelets ≥100 X109/L - Haemoglobin ≥9g/dL - aPTT ≤1.5 x ULN - Total bilirubin ≤1.5 mg/dL - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 times the upper limit of normal (ULN) if no liver involvement or ≤5 times the ULN with liver involvement. - Creatinine ≤1.5 x ULN, OR calculated or measured creatinine clearance ≥50 mL/min as calculated by the Cockcroft-Gault method, OR 24-hour measured urine creatinine clearance ≥50 mL/min.
Patients must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Predicted life expectancy ≥12 weeks
Patients should have willingness to comply with the study and follow up.
Male patients with female partners of childbearing potential should be willing to use two forms of acceptable contraception, including one barrier method, during their participation in this study and for 3 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 3 months after the last treatment.
Female patients should be using adequate contraceptive measures (see Section 3.3). All methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by their 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 child-bearing potential or must have evidence of non-child-bearing 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 been treated with most recent chemotherapy or investigational drugs ≤21 days or 5 half-lives (whichever is longer) for enrolment, and/or who have National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) v4.03 Grade 1 treatment-related side effect, with the exceptions of alopecia, should not be enrolled. For further details, please refer to the following link: http://evs.nci.nih.gov/ftp1/CTCAE/About.html.
Patients who received chemotherapy regimens given either continuously or weekly with limited potential for delayed toxicity or palliative/focal radiotherapy within the last 2 weeks or any other radiotherapy or immunotherapy within 3 weeks of the first dose of study treatment.
Major surgery (excluding placement of vascular access) ≤21 days of beginning of the study drug or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
Any of the following cardiac criteria: - Congestive heart failure (CHF) per New York Heart Association (NYHA) classification > Class II (see Appendix C) - Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy - Unstable angina or new-onset angina - QTcF >470 ms on screening electrocardiogram (ECG) by Fredericia's formula.
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 previously and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy.

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As judged by the investigator, any 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). Screening for chronic conditions is not required.
Concurrent conditions that in investigator's opinion would jeopardize compliance with protocol.
Psychological, familial, sociological, or geographical conditions that do not permit compliance with protocol.

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

United States3 sites

Research Site
Milwaukee, Wisconsin
Research Site
Nashville, Tennessee
Research Site
Sarasota, Florida

Other trials in United States

United Kingdom1 site

Research Site
London

Other trials in United Kingdom

About this study

Official title: A Phase I, Open-Label, Multicentre Dose-Escalation Study to Investigate the Safety and Pharmacokinetics of AZD5312 in Patients With Advanced Solid Tumours Where the Androgen Receptor Pathway is a Potential Factor

The study involves two parts, Part A, Dose Escalation and Part B, Dose Expansion.

Read the detailed description

This is a first time in man (FTIM), Phase I study to determine the Maxiimum Tolerated Dose, Recommended Phase 2 Dose, safety, tolerability and Pharmacokinetics of AZD5312. This is a multicentre study with sites in the United States and United Kingdom. Approximately 90 patients are expected to be enrolled in this study.The study involves two parts, Part A, Dose Escalation and Part B, Dose Expansion.

AZD5312 will be given intravenously (IV) as an infusion, over one hour. For the purpose of planning, each 4 week period (28 days) will be called a Cycle. AZD5312 will initially be administered 4 times within the first 11 days, (on Days [1, 4, 8 and 11]± 2), with no dosing on sequential days. Patients will receive weekly treatments on Days 15 and 22 to complete Cycle.

During the subsequent cycles, patients will receive weekly treatment on Days 1, 8, 15 and 22 (±2). The AZD5312 dose will not change unless dose reductions are required due to treatment-related toxicity. Patients will continue to receive AZD5312 until disease progression, intolerable toxicity, or discontinuation criteria have been met. Toxicity, Pharmacokinetics and biomarker data will be assessed throughout the study. Alternative infusion durations and/or treatment schedules may be explored if preliminary data suggest these would be more appropriate.

Conditions: Advanced Solid Tumours With Androgen Receptor Pathway as a Potential Factor
Being tested: AZD5312
Keywords: solid tumor, prostate cancer, breast cancer, bladder cancer, ovarian cancer, gastric cancer, salivary duct cancer
Medical subject headings: Prostatic Neoplasms, Breast Neoplasms, Urinary Bladder Neoplasms, Ovarian Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD5312Drug
Also called ISIS 560131
AZD5312 is a generation 2.5 antisense oligonucleotide (ASO) which is designed with the purpose of specifically suppressing human Androgen Receptor (AR) expression, thereby providing potential therapeutic benefit for the treatment of mCRPC and other AR-dependent cancers.

Study groups in NCT02144051
Study group	Role	What they receive
AZD5312	Experimental	AZD5312 will be given intravenously (IV) as an infusion, over one hour. For the purpose of planning, each 4 week period (28 days) will be called a Cycle. AZD5312 will initially be administered 4 times within the first 11 days, (on Days [1, 4, 8 and 11]± 2), with no dosing on sequential days. Patients will receive weekly treatments on Days 15 and 22 to complete Cycle 1. During the subsequent cycles, patients will receive weekly treatment on Days 1, 8, 15 and 22 (±2). Receives: Drug: AZD5312

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Tolerated Dose of AZD5312 in pts with advanced solid tumours where androgen receptor pathway is a potential factor.
The patient population used for determination of the MTD will consist of patients who have met the minimum safety evaluation requirements of the study, and/or who have experienced a DLT. Minimum safety requirements will be met if, during Cycle 1 of treatment, the patient receives all doses of AZD5312, completes all required safety evaluations, and is observed for at least 28 days following the first dose of AZD5312.
Measured: 13 months
Safety and tolerability of AZD5312 in patients assessed in terms of AEs, labs, vitals, ECGs and conc. med use.
Measured: 13 months
Recommended Phase 2 Dose of AZD5312 in patients with advanced solid tumours where androgen receptor pathway is a potential factor.
•3 evaluable patients (pts) will be enrolled at each dose level (3+3 design) •Evaluated for 28 days before escalation to next dose level. •If more than 1 experiences Dose Limiting Toxicity (DLT), additional 3 patients treated with the same dose. •Maximum of 6 pts enrolled per dose level. •100% increase in dosing until 2 pts (out of 3) at dose level experience toxicity of ≥ Grade 2, or 1 pt. experiences DLT. •Accelerated titration stopped, and subsequent dose escalation will be ≤ 50%. •Evaluation of a cohort of at least 3 patients completing 1 cycle of treatment (28 days) required prior to next dose level. •Dose escalation decisions take into account safety profile of prior dose groups, and available PK data. •Additional patients may be enrolled at lower doses for sufficient PK data. •Intermediate dose levels evaluated to declare the recommended Phase II dose (RP2D). When R2PD is determined, 12 patients will be treated at that dose level to further evaluate safety and efficacy.
Measured: 13 Months

Secondary outcomes (19)

Preliminary anti-tumour activity of AZD5312 in patients with advanced solid tumours.
•Proportion of mCRPC patients with a Prostate-specific antigen (PSA) response: Effect of AZD5312 on the PSA levels will be done by looking at PSA by waterfall plots according to the PCWG2 guidelines which measures (1) the percent difference from baseline at 12 weeks treatment points and (2) maximum decline in PSA at any point. •CTC conversions: For prostate cancer patients only, CTC conversions will be asessed which is defined as a significant change in CTC count from the baseline assessment. (Assess absolute reduction in CTC counts). •Metastatic bone disease status of mCRPC patients (PCWG2 criteria, (Scher et al, 2008). •Malignant soft tissue response rate will be assessed byResponse Evaluation Criteria in Solid Tumors (RECIST v1.1) (Eisenhauer et al. 2009) for all patients with measurable disease whenever possible.
Measured: 25 months
Pharmacokinetics of AZD5312 determined by Cmax
Measured: 25 months
Pharmacokinetics of AZD5312 determined by tmax
Measured: 25 months
Pharmacokinetics of AZD5312 determined by λz
Measured: 25 months
Pharmacokinetics of AZD5312 determined by t½λz
Measured: 25 months
Pharmacokinetics of AZD5312 determined by (AUC(0-24)
Measured: 25 months
Pharmacokinetics of AZD5312 determined by AUC(0-t)
Measured: 25 Months
Pharmacokinetics of AZD5312 determined by AUC
Measured: 25 months
Pharmacokinetics of AZD5312 determined by CL
Measured: 25 months
PK of AZD5312 determined Vz
Measured: 25 months
Pharmacokinetics of AZD5312 determined by MRT
Measured: 25 Months
Pharmacokinetics of AZD5312 determined by CLR
Measured: 25 Months
Pharmacokinetics of AZD5312 determined by Ae;%dose
Measured: 25 Months
Pharmacokinetics of AZD5312 determined by Css max
Measured: 25 Months
Pharmacokinetics of AZD5312 determined by tss max
Measured: 25 Months
Pharmacokinetics of AZD5312 determined by Css min
Measured: 25 Months
Pharmacokinetics of AZD5312 determined byAUCss
Measured: 25 Months
Pharmacokinetics of AZD5312 determined by CLss
Measured: 25 Months
Pharmacokinetics of AZD5312 determined by RAC
Measured: 25 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Mar 2016

First posted21 May 2014 (estimated)
Study startMay 2014
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid Tumours With Androgen Receptor Pathway as a Potential FactorStudies 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: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02144051
Sponsor's protocol ID: D5860C00001
Status last verified: Jul 2016
First submitted: 29 Apr 2014
Last updated: 14 Jul 2016
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2016. 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 AZD5312 in Patients With Advanced Solid Tumours Where the Androgen Receptor Pathway is a Potential Factor
ClinicalTrials.gov ID: NCT02144051
Acronym / sponsor ID: D5860C00001
Conditions: Advanced Solid Tumours With Androgen Receptor Pathway as a Potential Factor
Keywords: solid tumor, prostate cancer, breast cancer, bladder cancer, ovarian cancer, gastric cancer, salivary duct cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 21 May 2014 (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.

The study involves two parts, Part A, Dose Escalation and Part B, Dose Expansion.

Detailed description

During the subsequent cycles, patients will receive weekly treatment on Days 1, 8, 15 and 22 (±2). The AZD5312 dose will not change unless dose reductions are required due to treatment-related toxicity. Patients will continue to receive AZD5312 until disease progression, intolerable toxicity, or discontinuation criteria have been met. Toxicity, Pharmacokinetics and biomarker data will be assessed throughout the study. Alternative infusion durations and/or treatment schedules may be explored if preliminary data suggest these would be more appropriate.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AZD5312	Experimental	Drug: AZD5312AZD5312 will be given intravenously (IV) as an infusion, over one hour. For the purpose of planning, each 4 week period (28 days) will be called a Cycle. AZD5312 will initially be administered 4 times within the first 11 days, (on Days [1, 4, 8 and 11]± 2), with no dosing on sequential days. Patients will receive weekly treatments on Days 15 and 22 to complete Cycle 1. During the subsequent cycles, patients will receive weekly treatment on Days 1, 8, 15 and 22 (±2).

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Patient must understand nature of trial and provide a signed and dated, written informed consent form prior to study specific procedures, sampling and analyses. If a patient declines to participate in voluntary exploratory research and/or genetic component of study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other aspects of the study.
Part A Dose Escalation Patients must have histological or cytological confirmation of a solid tumour of either locally advanced or metastatic castrate resistant prostate cancer (mCRPC), breast, bladder, ovarian, gastric or salivary duct carcinoma where an Androgen Receptor pathway may be a potential factor.
Part B Dose Expansion.
Arm 1 Prostate cancer patients with prior second generation anti-hormonal therapy (examples: abiraterone, enzalutamide, TAK 700) without response (disease progression in ≤4 months or Stable Disease (SD) but Prostate-specific antigen (PSA) level did not decline ≥50%).
Arm 2 Prostate cancer patients with intial response to second generation anti-hormonal therapy (examples: abiraterone, enzalutamide, TAK 700), but later relapsed. Disease relapse would be defined as progressive disease at the time of entry demonstrated either by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (measurable disease) or by two subsequently increasing Prostate-specific antigen (PSA) values obtained at least one week apart. If clinically meaningful benefits have been identified in a non-mCRPC patient population during the escalation phase, a potential third expansion arm may be considered.

Key exclusion criteria (9 listed)

Patients who have been treated with most recent chemotherapy or investigational drugs ≤21 days or 5 half-lives (whichever is longer) for enrolment, and/or who have National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) v4.03 Grade 1 treatment-related side effect, with the exceptions of alopecia, should not be enrolled. For further details, please refer to the following link: http://evs.nci.nih.gov/ftp1/CTCAE/About.html.
Patients who received chemotherapy regimens given either continuously or weekly with limited potential for delayed toxicity or palliative/focal radiotherapy within the last 2 weeks or any other radiotherapy or immunotherapy within 3 weeks of the first dose of study treatment.
Major surgery (excluding placement of vascular access) ≤21 days of beginning of the study drug or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
Any of the following cardiac criteria: - Congestive heart failure (CHF) per New York Heart Association (NYHA) classification > Class II (see Appendix C) - Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy - Unstable angina or new-onset angina - QTcF >470 ms on screening electrocardiogram (ECG) by Fredericia's formula.
Patients with leptomeningeal metastases

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
AZD5312Also: ISIS 560131AZD5312 is a generation 2.5 antisense oligonucleotide (ASO) which is designed with the purpose of specifically suppressing human Androgen Receptor (AR) expression, thereby providing potential therapeutic benefit for the treatment of mCRPC and other AR-dependent cancers.	Drug	AZD5312

Primary outcome

Maximum Tolerated Dose of AZD5312 in pts with advanced solid tumours where androgen receptor pathway is a potential factor.
Time frame: 13 months
The patient population used for determination of the MTD will consist of patients who have met the minimum safety evaluation requirements of the study, and/or who have experienced a DLT. Minimum safety requirements will be met if, during Cycle 1 of treatment, the patient receives all doses of AZD5312, completes all required safety evaluations, and is observed for at least 28 days following the first dose of AZD5312.
Safety and tolerability of AZD5312 in patients assessed in terms of AEs, labs, vitals, ECGs and conc. med use.
Time frame: 13 months
Recommended Phase 2 Dose of AZD5312 in patients with advanced solid tumours where androgen receptor pathway is a potential factor.
Time frame: 13 Months
•3 evaluable patients (pts) will be enrolled at each dose level (3+3 design) •Evaluated for 28 days before escalation to next dose level. •If more than 1 experiences Dose Limiting Toxicity (DLT), additional 3 patients treated with the same dose. •Maximum of 6 pts enrolled per dose level. •100% increase in dosing until 2 pts (out of 3) at dose level experience toxicity of ≥ Grade 2, or 1 pt. experiences DLT. •Accelerated titration stopped, and subsequent dose escalation will be ≤ 50%. •Evaluation of a cohort of at least 3 patients completing 1 cycle of treatment (28 days) required prior to next dose level. •Dose escalation decisions take into account safety profile of prior dose groups, and available PK data. •Additional patients may be enrolled at lower doses for sufficient PK data. •Intermediate dose levels evaluated to declare the recommended Phase II dose (RP2D). When R2PD is determined, 12 patients will be treated at that dose level to further evaluate safety and efficacy.

19 secondary outcomes

Preliminary anti-tumour activity of AZD5312 in patients with advanced solid tumours.
Time frame: 25 months
Pharmacokinetics of AZD5312 determined by Cmax
Time frame: 25 months
Pharmacokinetics of AZD5312 determined by tmax
Time frame: 25 months
Pharmacokinetics of AZD5312 determined by λz
Time frame: 25 months
Pharmacokinetics of AZD5312 determined by t½λz
Time frame: 25 months
Pharmacokinetics of AZD5312 determined by (AUC(0-24)
Time frame: 25 months
Pharmacokinetics of AZD5312 determined by AUC(0-t)
Time frame: 25 Months
Pharmacokinetics of AZD5312 determined by AUC
Time frame: 25 months
Pharmacokinetics of AZD5312 determined by CL
Time frame: 25 months
PK of AZD5312 determined Vz
Time frame: 25 months
Pharmacokinetics of AZD5312 determined by MRT
Time frame: 25 Months
Pharmacokinetics of AZD5312 determined by CLR
Time frame: 25 Months
Pharmacokinetics of AZD5312 determined by Ae;%dose
Time frame: 25 Months
Pharmacokinetics of AZD5312 determined by Css max
Time frame: 25 Months
Pharmacokinetics of AZD5312 determined by tss max
Time frame: 25 Months
Pharmacokinetics of AZD5312 determined by Css min
Time frame: 25 Months
Pharmacokinetics of AZD5312 determined byAUCss
Time frame: 25 Months
Pharmacokinetics of AZD5312 determined by CLss
Time frame: 25 Months
Pharmacokinetics of AZD5312 determined by RAC
Time frame: 25 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 14 Jul 2016.

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.

Howard Burris, MD principal investigator

SCRI Development Innovations, LLC

4 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 AZD5312 in people with Advanced Solid Tumours With Androgen Receptor Pathway as a Potential Factor, run by AstraZeneca at 4 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 16 inclusion and 9 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 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 of AZD5312 in pts with advanced solid tumours where androgen receptor pathway is a potential factor. (time frame: 13 months). The study lists 3 primary outcomes in all. 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 NCT02144051.

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 14 Jul 2016.