CancerPhase 1NCT01194193

Preliminary Anti-tumour Activity of mTor Kinase Inhibitor in Advanced Tumours

A Phase 1 study testing AZD8055 in people with Cancer and Advanced Solid Tumours, run by AstraZeneca.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

To investigate the safety and tolerability of AZD8055 intermittent dosing schedules when given orally to patients with advanced solid malignancies and lymphomas. Two intermittent dosing schedules will be explored with increasing doses until a maximum tolerated dose is determined for each schedule. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer, Advanced Solid Tumours, Lymphomas
What is being tested?: AZD8055
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: No sites listed yet
Study dates: Start not givento not given
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

Histological or cytological confirmation of an advanced solid malignant tumour or lymphoma which is refactory to standard therapies or for which no standard therapy exists, patients with measurable or non-measurable disease (according to RECIST criteria)
WHO performance status 0-2
Evidence of post-menopausal status or negative urine/serum pregnancy test for pre-menopausal female patients

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 from first dose of study drug.
Any investigational agents or study drugs from a previous clinical study within 30 days, any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
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

About this study

Official title: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of the m-Tor Kinase Inhibitor AZD8055 Using Intermittent Dosing Schedules in Patients With Advanced Solid Malignancies and Lymphomas

Conditions: Cancer, Advanced Solid Tumours, Lymphomas
Being tested: AZD8055
Keywords: Cancer, Advanced solid tumours, lymphomas, dose escalation, preliminary anti-tumour activity, Tor kinase inhibitor, oral administration, intermittent dosing
Medical subject headings: Neoplasms, Lymphoma

What participants receive

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

AZD8055Drug
Oral tablet, single dose on Day 1, followed by a 48 hour - 7 day washout and then either twice daily alternate days dosing from multiple dose day 1 onwards or twice daily dosing for 21 days from multiple dose day 1 onwards followed by 7 days no treatment. Cycles of 28 days.

Study groups in NCT01194193
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: AZD8055

What is being measured

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

Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Measured: Evaluability period is 5 weeks (visit 5), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Measured: Evaluability period is 5 weeks (visit 6), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Measured: Evaluability period is 5 weeks (visit 7), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Measured: Evaluability period is 5 weeks (visit 8), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Measured: Evaluability period is 5 weeks (visit 9), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Measured: Evaluability period is 5 weeks (visit 10), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Measured: Evaluability period is 5 weeks (visit 11), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Measured: Evaluability period is 5 weeks (visit 12), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Measured: Evaluability period is 5 weeks (visit 13), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Measured: Evaluability period is 5 weeks (visit 14), although safety and tolerability parameters will be measured at all visits.
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Measured: 1 cycle (3-4 weeks, at visit 2)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Measured: 1 cycle (3-4 weeks, at visit 3)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Measured: 1 cycle (3-4 weeks, at visit 4)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Measured: 1 cycle (3-4 weeks, at visit 6)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Measured: 1 cycle (3-4 weeks, at visit 7)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Measured: 1 cycle (3-4 weeks, at visit 8)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Measured: 1 cycle (3-4 weeks, at visit 9)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Measured: 1 cycle (3-4 weeks, at visit 10)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Measured: 1 cycle (3-4 weeks, at visit 11)

Secondary outcomes (2)

Preliminary assessment of the anti-tumour activity of AZD8055; Evalution of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 and percentage change in tumour size and measurement of serological biomarkers.
Measured: Every 2 cycles (at visits 1, 17, every subsequent 8 weeks, visit 100
Investigation of possible relationships between plasma AZD8055 concentrations / exposure and changes in safety parameters (including number and types of adverse events).
Measured: 1 cycle (3-4 weeks, at visits 2, 3, 4, 6-11)

Timeline

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

First posted2 Sep 2010 (estimated)

Why it stopped: Amendment to study compound development programme

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 63 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01194193
Sponsor's protocol ID: D1600C00002
Status last verified: May 2011
First submitted: 18 Aug 2010
Last updated: 16 May 2011
Results posted: No
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?

Official record

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All Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2011. 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 Anti-tumour Activity of the m-Tor Kinase Inhibitor AZD8055 Using Intermittent Dosing Schedules in Patients With Advanced Solid Malignancies and Lymphomas
ClinicalTrials.gov ID: NCT01194193
Acronym / sponsor ID: D1600C00002
Conditions: Cancer, Advanced Solid Tumours, Lymphomas
Keywords: Cancer, Advanced solid tumours, lymphomas, dose escalation, preliminary anti-tumour activity, Tor kinase inhibitor, oral administration, intermittent dosing
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Amendment to study compound development programme
Enrolment: 63 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
First posted: 2 Sep 2010 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: AZD8055

Who may qualify

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

Key inclusion criteria (3 listed)

Histological or cytological confirmation of an advanced solid malignant tumour or lymphoma which is refactory to standard therapies or for which no standard therapy exists, patients with measurable or non-measurable disease (according to RECIST criteria)
WHO performance status 0-2
Evidence of post-menopausal status or negative urine/serum pregnancy test for pre-menopausal female patients

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 from first dose of study drug.
Any investigational agents or study drugs from a previous clinical study within 30 days, any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
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
AZD8055Oral tablet, single dose on Day 1, followed by a 48 hour - 7 day washout and then either twice daily alternate days dosing from multiple dose day 1 onwards or twice daily dosing for 21 days from multiple dose day 1 onwards followed by 7 days no treatment. Cycles of 28 days.	Drug	1

Primary outcome

Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 5), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 6), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 7), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 8), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 9), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 10), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 11), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 12), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 13), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 14), although safety and tolerability parameters will be measured at all visits.
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 2)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 3)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 4)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 6)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 7)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 8)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 9)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 10)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 11)

2 secondary outcomes

Preliminary assessment of the anti-tumour activity of AZD8055; Evalution of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 and percentage change in tumour size and measurement of serological biomarkers.
Time frame: Every 2 cycles (at visits 1, 17, every subsequent 8 weeks, visit 100
Investigation of possible relationships between plasma AZD8055 concentrations / exposure and changes in safety parameters (including number and types of adverse events).
Time frame: 1 cycle (3-4 weeks, at visits 2, 3, 4, 6-11)

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2011.

Related trials for Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian 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.

Ian Smith, MD study director

AstraZeneca R&D

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD8055 in people with Cancer and Advanced Solid Tumours, run by AstraZeneca.

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: withdrawn, as of the sponsor's last update on 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations. (time frame: Evaluability period is 5 weeks (visit 5), although safety and tolerability parameters will be measured at all visits.). The study lists 19 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 NCT01194193.

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 16 May 2011.