Advanced Solid MalignanciesPhase 1NCT01588548

Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma

A Phase 1 study testing AZD1208 in people with Advanced Solid Malignancies and Malignant Lymphoma, run by AstraZeneca at 3 sites in 2 countries.

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

The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when given daily to patients with advanced solid malignancies including malignant lymphoma Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Advanced Solid Malignancies, Malignant Lymphoma
What is being tested?: AZD1208
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 3 sitesin 2 countries
Study dates: Jul 2012to Jul 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 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who have signed this Written Informed Consent Form after a full explanation about the participation in this study
Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or malignant lymphoma that is refractory to standard therapies or for which no standard therapies exist
Patients with good physical conditions (you can walk and can look after yourself) within the last 2 weeks.
Patients who have at least one lesion that can be accurately assessed

Who cannot join

Patients who have recently received or are receiving prohibited medications or treatments
Patients who have any unresolved side effects of previous treatments
Patients who have spinal cord compression or brain metastases
Patients who have severe systemic diseases (e.g., uncontrolled hypertension, hepatitis B, hepatitis C and human immunodeficiency virus [HIV] infection)
Patients with significant abnormal ECG findings

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

United Kingdom2 sites

Research Site
Manchester
Research Site
Surrey

Other trials in United Kingdom

Japan1 site

Research Site
Chūōku

Other trials in Japan

About this study

Official title: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients With Advanced Solid Malignancies Including Malignant Lymphoma

Read the detailed description

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients with Advanced Solid Malignancies including Malignant Lymphoma

Conditions: Advanced Solid Malignancies, Malignant Lymphoma
Being tested: AZD1208
Keywords: Advanced solid malignancies, Malignant lymphoma
Medical subject headings: Lymphoma

What participants receive

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

AZD1208Drug
Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose

Study groups in NCT01588548
Study group	Role	What they receive
AZD1208	Active comparator	Not described Receives: Drug: AZD1208

What is being measured

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

Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period.
Measured: Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1

Timeline

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

Jul 2012Jul 2014

First posted1 May 2012 (estimated)
Study startJul 2012
Primary completionJul 2014
Study completionJul 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01588548
Sponsor's protocol ID: D4510C00005
Status last verified: Oct 2015
First submitted: 27 Apr 2012
Last updated: 4 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

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
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Malignancies trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2015. 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 Ascending Doses of AZD1208 in Patients With Advanced Solid Malignancies Including Malignant Lymphoma
ClinicalTrials.gov ID: NCT01588548
Acronym / sponsor ID: D4510C00005
Conditions: Advanced Solid Malignancies, Malignant Lymphoma
Keywords: Advanced solid malignancies, Malignant lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 1 May 2012 (estimated)
Results: Posted 19 Aug 2015

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
AZD1208	Active comparator	Drug: AZD1208

Who may qualify

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

Key inclusion criteria (4 listed)

Patients who have signed this Written Informed Consent Form after a full explanation about the participation in this study
Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or malignant lymphoma that is refractory to standard therapies or for which no standard therapies exist
Patients with good physical conditions (you can walk and can look after yourself) within the last 2 weeks.
Patients who have at least one lesion that can be accurately assessed

Key exclusion criteria (5 listed)

Patients who have recently received or are receiving prohibited medications or treatments
Patients who have any unresolved side effects of previous treatments
Patients who have spinal cord compression or brain metastases
Patients who have severe systemic diseases (e.g., uncontrolled hypertension, hepatitis B, hepatitis C and human immunodeficiency virus [HIV] infection)
Patients with significant abnormal ECG findings

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
AZD1208Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose	Drug	AZD1208

Primary outcome

Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)
Time frame: Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period.

Results and safety

Results posted to the registry on 19 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD1208 120mg	3	0
AZD1208 240mg	7	0
AZD1208 360mg	6	0
AZD1208 540mg	7	0
AZD1208 700mg	6	0
AZD1208 800mg	6	0

Primary outcome: Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)

Time frame: Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1. Number. Unit: Participants

Measure	AZD1208 120mg n = 3	AZD1208 240mg n = 7	AZD1208 360mg n = 5	AZD1208 540mg n = 7	AZD1208 700mg n = 6	AZD1208 800mg n = 5
CR	0	0	0	0	0	0
PR	0	0	0	0	0	0
SD >=6 weeks (unconfirmed CR or PR)	0	0	0	0	0	0
SD >=6 weeks (SD)	2	5	1	3	1	1
PD (RECIST progression)	1	2	3	3	2	3
PD (Death)	0	0	0	0	1	0
Not evaluable (SD < 6 weeks)	0	0	1	0	2	0
Not evaluable(Incomplete postbaseline assessments)	0	0	0	1	0	1

Population analysed: All patients who were evaluable for Response analysis set for RECIST criteria

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD1208 120mg	0 of 3 (0%)	3 of 3 (100%)	Not reported
AZD1208 240mg	2 of 7 (28.6%)	7 of 7 (100%)	Not reported
AZD1208 360mg	2 of 6 (33.3%)	6 of 6 (100%)	Not reported
AZD1208 540mg	2 of 7 (28.6%)	7 of 7 (100%)	Not reported
AZD1208 700mg	2 of 6 (33.3%)	6 of 6 (100%)	Not reported
AZD1208 800mg	0 of 6 (0%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
CSR\_Synopsis\_D4510C00005.pdfLink provided by the sponsor.

Related trials for Advanced Solid Malignancies

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
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

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.

Frank Neumann, MSD study director

3 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 AZD1208 in people with Advanced Solid Malignancies and Malignant Lymphoma, run by AstraZeneca at 3 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 4 inclusion and 5 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 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom, Japan. 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 19 Aug 2015). 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?

Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) (time frame: Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1). 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 NCT01588548.

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 Nov 2015.