Solid TumorsPhase 1NCT00497731
AZD1152 in Patients With Advanced Solid Malignancies-Study 1
A Phase 1 study testing AZD1152 in people with Solid Tumors, run by AstraZeneca at 2 sites in Netherlands.
Trial summary
The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 2-hour infusion every week and every 2 weeks in patients with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- AZD1152
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 2 sitesNetherlands
- Study dates
- May 2005to Apr 2009
- 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 a solid, malignant tumour
- At least measurable or non measurable site of disease as defined by modified RECIST criteria.
Who cannot join
- Participation in an investigational drug study within 30 days prior to entry or who have not recovered from the effects of an investigational study drug
- Treatment with radiotherapy/chemotherapy with 4 weeks of first dose
- Recent major surgery within 4 weeks prior to entry to the study
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a 2 Hour Intravenous Infusion on Two Dose Schedules in Patients With Advanced Solid Malignancies
The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 2-hour infusion every week and every 2 weeks in patients with advanced solid malignancies.
- Conditions
- Solid Tumors
- Being tested
- AZD1152
- Keywords
- Advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1152Drug
2-hour continuous intravenous infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Measured: Assessed at each visit
Secondary outcomes (3)
Pharmacokinetics
Measured: Assessed at predetermined timepoints after dose administration
Effect on biomarkers
Measured: Assessed after treatment
Anti-tumor activity
Measured: Assessed after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startMay 2005
- Primary completionJun 2008
- Study completionApr 2009 (estimated)
Why it stopped: Efficacy seen in the solid tumour patient population was not sufficient to continue research with AZD1152 monotherapy in solid tumors at that time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jan Schellens, MD, Principal investigator, NKI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497731
- Sponsor's protocol ID
- D1531C00001
- Status last verified
- Jun 2009
- First submitted
- 5 Jul 2007
- Last updated
- 22 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a 2 Hour Intravenous Infusion on Two Dose Schedules in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00497731
- Acronym / sponsor ID
- D1531C00001
- Conditions
- Solid Tumors
- Keywords
- Advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Efficacy seen in the solid tumour patient population was not sufficient to continue research with AZD1152 monotherapy in solid tumors at that time.
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Apr 2009 (estimated)
- First posted
- 9 Jul 2007 (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 primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 2-hour infusion every week and every 2 weeks in patients with advanced solid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histological or cytological confirmation of a solid, malignant tumour
- At least measurable or non measurable site of disease as defined by modified RECIST criteria.
Key exclusion criteria (3 listed)
- Participation in an investigational drug study within 30 days prior to entry or who have not recovered from the effects of an investigational study drug
- Treatment with radiotherapy/chemotherapy with 4 weeks of first dose
- Recent major surgery within 4 weeks prior to entry to the study
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 |
|---|---|---|
| AZD11522-hour continuous intravenous infusion | Drug | – |
Primary outcome
Safety and Tolerability
Time frame: Assessed at each visit
3 secondary outcomes
Pharmacokinetics
Time frame: Assessed at predetermined timepoints after dose administration
Effect on biomarkers
Time frame: Assessed after treatment
Anti-tumor activity
Time frame: Assessed after treatment
Results and safety
The study was stopped early (reason given: Efficacy seen in the solid tumour patient population was not sufficient to continue research with AZD1152 monotherapy in solid tumors at that time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2009.
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A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
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A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
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.
Jan Schellens, MD principal investigator
NKI
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 AZD1152 in people with Solid Tumors, run by AstraZeneca at 2 sites in Netherlands.
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 2 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: stopped early, as of the sponsor's last update on 22 Jun 2009. 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 Netherlands. 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 was stopped early (reason given: Efficacy seen in the solid tumour patient population was not sufficient to continue research with AZD1152 monotherapy in solid tumors at that time.). Results are not available in the source record.
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 (time frame: Assessed at each visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2009.