Advanced Solid MalignanciesPhase 1NCT01026402

Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of AZD2014

A Phase 1 study testing AZD2014 in people with Advanced Solid Malignancies, run by AstraZeneca at 2 sites in United Kingdom.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 150 years
Conditions the study is for: Advanced Solid Malignancies
What is being tested?: AZD2014
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 172 participants
Where: 2 sitesUnited Kingdom
Study dates: Dec 2009to Aug 2014
Phase: Phase 1
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 to 150 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histological or cytological confirmation of a solid, malignant tumour that is refractory to standard therapies or for which no standard therapies exist
At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment
World Health Organisation performance status 0-2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks

Who cannot join

Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks prior to first dose of study drug
Patients with abnormal fasting glucose, type I or uncontrolled type II diabetes
Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

Research Site
Manchester
Research Site
Sutton

Other trials in United Kingdom

About this study

Official title: A Phase I, Open Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTor Kinase Inhibitor AZD2014 Administered Orally to Patients With Advanced Solid Malignancies

The main purpose of the study is to establish a safe dose of the drug by providing information on any potential side effects this drug may cause and collecting data about how a patient's cancer responds to the drug. The study will also assess the blood levels and action of AZD2014 in the body over a period of time and will indicate whether the drug has an effect on the types of cancer the patients have.

Conditions: Advanced Solid Malignancies
Being tested: AZD2014
Keywords: Phase I, cancer, advanced solid malignancies, dose escalation, AZD2014, mTor kinase inhibitor, safety, pharmacokinetics
Medical subject headings: Neoplasms

What participants receive

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

AZD2014Drug
Dose escalation phase: a single dose taken orally (solution or tablet) of AZD2014 on single dose day 1 (visit 2), followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or Single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal. Expansion phase: twice daily dosing from day 1 until discontinuation or withdrawal or a single dose taken orally of AZD2014 on single dose day 1 (visit 2), followed by a single dose on second single dose day 1 (visit 3) after a washout period (48 hours - 7 days) followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal.

Study groups in NCT01026402
Study group	Role	What they receive
AZD2014	Experimental	AZD2014 dose escalation phase in Part A and expansion phase in Part B. Receives: Drug: AZD2014

What is being measured

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

Number of Participants With Dose Limiting Toxicities (DLTs)
Maximum Tolerated Dose (MTD) was determined by testing various doses and schedules of AZD2014 in cohorts of 3-6 evaluable patients. MTD reflects the highest dose of drug at each schedule that did not cause a DLT in >1 patient
Measured: Up to 21 days from first multiple dose

Secondary outcomes (15)

Best Objective Response
Best Objective Response per Response Evaluation Criteria in Solid Tumours Criteria (RECIST) 1.1 for target and non target lesions assessed by CT, MRI or X-ray; Complete Response (CR), Disappearance of all target lesions since baseline; Partial Response (PR), At least a 30 percent decrease in the sum of diameters of target lesions; Progressive Disease (PD), At least a 20 percent increase in the sum of diameters of target lesions and an absolute increase of at least 5mm
Measured: Assessed every 8 weeks until progression or withdrawal, whichever came first, estimated to be up to 4 months
Maximum Concentration (Cmax) Single Dose
Maximum concentration following single dose (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)
Measured: Following Single Dose up to 12, 24 or 48 hours post dose
Area Under the Curve (AUC) Single Dose
Area under the curve following single dose Continuous dosing - AUC parameter used Intermittent dosing - AUC(0-12) used (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)
Measured: Following Single Dose up to 12, 24 or 48 hours post dose
Maximum Concentration (Cmax) at Steady State
Cmax at steady state (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)
Measured: Multiple dosing to steady state (up to 12 or 48 hours post dose)
Area Under the Curve (AUC) at Steady State
AUC at steady state Continuous dosing - AUCss used Intermittent dosing - Weekly AUC used (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)
Measured: Multiple dosing to steady state (up to 12 or 48 hours post dose)
Urine PK - Fraction Dose Excreted (fe(0-12)) Single Dose
Fraction dose excreted unchanged in the urine from 0-12 hours after a single dose (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)
Measured: Pre dose through to 12 hours post dose
Urine PK - Fraction Dose Excreted (fe(0-12)) at Steady State
Fraction dose excreted unchanged in the urine from 0-12 hours after dosing (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)
Measured: Pre dose through to 24 hours post dose
Urine PK - Renal Clearance (Renal CL) Single Dose
Renal Clearance (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)
Measured: Pre dose through to 24 hours post dose
Urine PK - Renal Clearance (Renal CL) at Steady State
Renal Clearance (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)
Measured: Pre dose through to 24 hours post dose
Percent Change From Baseline in p4EBP1 at 2 Hours Post Dose
Phosphorylation levels of 4EBP1 from peripheral blood mononuclear cell (Patients with undetectable values at baseline have been excluded)
Measured: predose and 2 hours after a single dose
Percent Change From Baseline in pAKT (S473) in Platelet Rich Plasma (PRP) at 2 Hours Post Dose
Phosphorylation levels of AKT from PRP (Patients with undetectable values at baseline have been excluded)
Measured: predose and 2 hours after a single dose
Partial Metabolic Response (PMR), Cycle 1
Partial metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)
Measured: Cycle 1 Day 8
Partial Metabolic Response (PMR), Cycle 2
Partial metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)
Measured: Cycle 2 Day 8
Complete Metabolic Response (CMR), Cycle 1
Complete metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)
Measured: Cycle 1 Day 8
Complete Metabolic Response (CMR), Cycle 2
Complete metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)
Measured: Cycle 2 Day 8

Timeline

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

Dec 2009Aug 2014

First posted4 Dec 2009 (estimated)
Study startDec 2009
Primary completionAug 2014
Study completionAug 2014

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 Advanced Solid MalignanciesStudies 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: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01026402
Sponsor's protocol ID: D2270C00001
Other IDs: 2009-015244-42, 2009
Status last verified: Jan 2016
First submitted: 3 Dec 2009
Last updated: 11 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Active, not recruitingPhase 2
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RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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All Advanced Solid Malignancies trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTor Kinase Inhibitor AZD2014 Administered Orally to Patients With Advanced Solid Malignancies
ClinicalTrials.gov ID: NCT01026402
Acronym / sponsor ID: D2270C00001
Conditions: Advanced Solid Malignancies
Keywords: Phase I, cancer, advanced solid malignancies, dose escalation, AZD2014, mTor kinase inhibitor, safety, pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 4 Dec 2009 (estimated)
Results: Posted 11 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

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

Arm	Type	Receives
AZD2014	Experimental	Drug: AZD2014AZD2014 dose escalation phase in Part A and expansion phase in Part B.

Who may qualify

Ages: 18 to 150 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Histological or cytological confirmation of a solid, malignant tumour that is refractory to standard therapies or for which no standard therapies exist
At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment
World Health Organisation performance status 0-2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks

Key exclusion criteria (3 listed)

Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks prior to first dose of study drug
Patients with abnormal fasting glucose, type I or uncontrolled type II diabetes
Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions

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
AZD2014Dose escalation phase: a single dose taken orally (solution or tablet) of AZD2014 on single dose day 1 (visit 2), followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or Single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal. Expansion phase: twice daily dosing from day 1 until discontinuation or withdrawal or a single dose taken orally of AZD2014 on single dose day 1 (visit 2), followed by a single dose on second single dose day 1 (visit 3) after a washout period (48 hours - 7 days) followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal.	Drug	AZD2014

Primary outcome

Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Up to 21 days from first multiple dose
Maximum Tolerated Dose (MTD) was determined by testing various doses and schedules of AZD2014 in cohorts of 3-6 evaluable patients. MTD reflects the highest dose of drug at each schedule that did not cause a DLT in >1 patient

15 secondary outcomes

Best Objective Response
Time frame: Assessed every 8 weeks until progression or withdrawal, whichever came first, estimated to be up to 4 months
Maximum Concentration (Cmax) Single Dose
Time frame: Following Single Dose up to 12, 24 or 48 hours post dose
Area Under the Curve (AUC) Single Dose
Time frame: Following Single Dose up to 12, 24 or 48 hours post dose
Maximum Concentration (Cmax) at Steady State
Time frame: Multiple dosing to steady state (up to 12 or 48 hours post dose)
Area Under the Curve (AUC) at Steady State
Time frame: Multiple dosing to steady state (up to 12 or 48 hours post dose)
Urine PK - Fraction Dose Excreted (fe(0-12)) Single Dose
Time frame: Pre dose through to 12 hours post dose
Urine PK - Fraction Dose Excreted (fe(0-12)) at Steady State
Time frame: Pre dose through to 24 hours post dose
Urine PK - Renal Clearance (Renal CL) Single Dose
Time frame: Pre dose through to 24 hours post dose
Urine PK - Renal Clearance (Renal CL) at Steady State
Time frame: Pre dose through to 24 hours post dose
Percent Change From Baseline in p4EBP1 at 2 Hours Post Dose
Time frame: predose and 2 hours after a single dose
Percent Change From Baseline in pAKT (S473) in Platelet Rich Plasma (PRP) at 2 Hours Post Dose
Time frame: predose and 2 hours after a single dose
Partial Metabolic Response (PMR), Cycle 1
Time frame: Cycle 1 Day 8
Partial Metabolic Response (PMR), Cycle 2
Time frame: Cycle 2 Day 8
Complete Metabolic Response (CMR), Cycle 1
Time frame: Cycle 1 Day 8
Complete Metabolic Response (CMR), Cycle 2
Time frame: Cycle 2 Day 8

Results and safety

Results posted to the registry on 11 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A 25mg BD Soln Cont	6	6
Part A 50mg BD Soln Cont	8	8
Part B 50mg BD Soln Cont	33	33
Part B Fed/Fasted 50mg BD Tab Cont	18	18
Part A 75mg QD Soln Cont	3	3
Part A 125mg QD Soln Cont	5	5
Part A 100mg QD Tab Cont	8	8
Part A 125mg QD Tab Cont	3	3
Part A 175mg QD Tab Cont	7	7
Part A 100mg BD Tab Int	3	3
Part A 125mg BD Tab Int	7	7
Part A 170mg BD Tab Int	8	8
Part A 225mg BD Tab Int	8	8
Part B 125mg BD Tab Int	6	6
Part B 170mg BD Tab Int	3	3
Part A 70mg BD Soln Cont	5	5
Part A 100mg BD Soln Cont	4	4

Primary outcome: Number of Participants With Dose Limiting Toxicities (DLTs)

Time frame: Up to 21 days from first multiple dose. Number. Unit: Participants

Measure	Part A 25mg BD Soln Cont n = 6	Part A 50mg BD Soln Cont n = 6	Part B 50mg BD Soln Cont n = 0	Part B Fed/Fasted 50mg BD Tab Cont n = 0	Part A 75mg QD Soln Cont n = 3	Part A 125mg QD Soln Cont n = 3	Part A 100mg QD Tab Cont n = 6	Part A 125mg QD Tab Cont n = 2	Part A 175mg QD Tab Cont n = 2	Part A 100mg BD Tab Int n = 3	Part A 125mg BD Tab Int n = 6	Part A 170mg BD Tab Int n = 6	Part A 225mg BD Tab Int n = 5	Part B 125mg BD Tab Int n = 6	Part B 170mg BD Tab Int n = 3	Part A 70mg BD Soln Cont n = 4	Part A 100mg BD Soln Cont n = 4
Value	0	0	–	–	0	0	0	2	2	0	0	0	2	0	3	2	4

Part A 25mg BD Soln Cont vs Part A 50mg BD Soln Cont vs Part A 70mg BD Soln Cont vs Part A 100mg BD Soln Cont: Maximum Tolerated Dose: 50
Part A 75mg QD Soln Cont vs Part A 125mg QD Soln Cont vs Part A 100mg QD Tab Cont vs Part A 125mg QD Tab Cont vs Part A 175mg QD Tab Cont: Maximum Tolerated Dose: 100
Part A 100mg BD Tab Int vs Part A 125mg BD Tab Int vs Part A 170mg BD Tab Int vs Part A 225mg BD Tab Int vs Part B 125mg BD Tab Int vs Part B 170mg BD Tab Int: Maximum Tolerated Dose: 125

Population analysed: Safety Analysis Set - All patients that received at least 1 dose of AZD2014. This includes dosed patients who are not evaluable for dose escalation decision purposes.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: At each visit from screening through to 30 day follow up (estimated to be up to 4 months, plus 30 days follow up). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A - AZD2014 100 mg BD Solution	1 of 4 (25%)	4 of 4 (100%)	Not reported
Part A - AZD2014 100 mg QD Tablet	4 of 8 (50%)	8 of 8 (100%)	Not reported
Part A - AZD2014 125 mg QD Solution	0 of 5 (0%)	5 of 5 (100%)	Not reported
Part A - AZD2014 125 mg QD Tablet	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Part A - AZD2014 175 mg QD Tablet	4 of 7 (57.1%)	7 of 7 (100%)	Not reported
Part A - AZD2014 25 mg BD Solution	5 of 6 (83.3%)	6 of 6 (100%)	Not reported
Part A - AZD2014 50 mg BD Solution	0 of 8 (0%)	8 of 8 (100%)	Not reported
Part A - AZD2014 70 mg BD Solution	2 of 5 (40%)	5 of 5 (100%)	Not reported
Part A - AZD2014 75 mg QD Solution	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Part A - Intermittent AZD2014 100 mg BD Tablet	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Part A - Intermittent AZD2014 125 mg BD Tablet	3 of 7 (42.9%)	7 of 7 (100%)	Not reported
Part A - Intermittent AZD2014 170 mg BD Tablet	3 of 8 (37.5%)	8 of 8 (100%)	Not reported
Part A - Intermittent AZD2014 225 mg BD Tablet	6 of 8 (75%)	8 of 8 (100%)	Not reported
Part B - AZD2014 50 mg BD Solution	11 of 33 (33.3%)	32 of 33 (97%)	Not reported
Part B - AZD2014 50 mg BD Tablet Fasted/Fed	4 of 9 (44.4%)	9 of 9 (100%)	Not reported
Part B - AZD2014 BD 50 mg Tablet Fed/Fasted	3 of 9 (33.3%)	9 of 9 (100%)	Not reported
Part B - Intermittent AZD2014 125 mg BD Tablet

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Advanced Solid Malignancies

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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.

Dr. Udai Banerji principal investigator

The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey SM2 5PT

Elisabeth Oelmann study director

AstraZeneca

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 AZD2014 in people with Advanced Solid Malignancies, run by AstraZeneca at 2 sites in United Kingdom.

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 3 inclusion and 3 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 11 Feb 2016. 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 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?

Yes. Results are posted in the registry (first posted 11 Feb 2016). 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 Participants With Dose Limiting Toxicities (DLTs) (time frame: Up to 21 days from first multiple dose). 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 NCT01026402.

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 11 Feb 2016.