Advanced Solid TumorsPhase 1NCT00473616
Phase I Single Ascending Dose/Multiple Ascending Dose in Patients Treated With AZD7762 and Irinotecan
A Phase 1 study testing AZD7762 and Irinotecan in people with Advanced Solid Tumors and Cancer, run by AstraZeneca at 3 sites in United States.
Trial summary
This is an open-label, multi-center, dose-escalation and safety expansion, Phase I study to evaluate the safety, tolerability, and pharmacokinectics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with irinotecan. The study is sponsored by AstraZeneca. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Cancer, Advanced Solid Malignancies
- What is being tested?
- AZD7762 and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2007to Jan 2011
- 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
- Advanced solid tumors for which standard treatment doesn't exist or is no longer effective.
- Must be suitable for treatment with irinotecan
- Relatively good overall health other than your cancer
Who cannot join
- Poor bone marrow function (not producing enough blood cells)
- Serious heart conditions
- Poor liver or kidney function
- Any prior anthracycline treatment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Boston, Massachusetts
Research site
Nashville, Tennessee
Research Site
New York, New York
About this study
Official title: A Phase I Open-label, Multi-center, Dose-escalation and Safety Expansion Study to Assess Safety, Tolerability, and Pharmacokinectics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose of Irinotecan in Patients With Advanced Solid Malignancies.
This is an open-label, multi-center, dose-escalation and safety expansion, Phase I study to evaluate the safety, tolerability, and pharmacokinectics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with irinotecan. The study is sponsored by AstraZeneca.
- Conditions
- Advanced Solid Tumors, Cancer, Advanced Solid Malignancies
- Being tested
- AZD7762, Irinotecan
- Keywords
- Phase I, solid tumors, solid malignancies, cancer Eligibility
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7762Drug
intravenous infusion
IrinotecanDrug
Also called Campto®, Camptosar®, irinotecan hydrochloride
intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD7762 monotherapy followed by AZD7762 + irinotecan Receives: Drug: AZD7762; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan
Measured: assessed after each course of treatment
Secondary outcomes (1)
To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762.
Measured: assessed after each course of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Termination of the study was made after a full review of program data and assessment of the current risk-benefit profile.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Langmuir, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473616
- Sponsor's protocol ID
- D1040C00004
- Status last verified
- Feb 2011
- First submitted
- 14 May 2007
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label, Multi-center, Dose-escalation and Safety Expansion Study to Assess Safety, Tolerability, and Pharmacokinectics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose of Irinotecan in Patients With Advanced Solid Malignancies.
- ClinicalTrials.gov ID
- NCT00473616
- Acronym / sponsor ID
- D1040C00004
- Conditions
- Advanced Solid Tumors, Cancer, Advanced Solid Malignancies
- Keywords
- Phase I, solid tumors, solid malignancies, cancer Eligibility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination of the study was made after a full review of program data and assessment of the current risk-benefit profile.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 15 May 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.
This is an open-label, multi-center, dose-escalation and safety expansion, Phase I study to evaluate the safety, tolerability, and pharmacokinectics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with irinotecan. The study is sponsored by AstraZeneca.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD7762, Drug: IrinotecanAZD7762 monotherapy followed by AZD7762 + irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Advanced solid tumors for which standard treatment doesn't exist or is no longer effective.
- Must be suitable for treatment with irinotecan
- Relatively good overall health other than your cancer
Key exclusion criteria (4 listed)
- Poor bone marrow function (not producing enough blood cells)
- Serious heart conditions
- Poor liver or kidney function
- Any prior anthracycline treatment
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 |
|---|---|---|
| AZD7762intravenous infusion | Drug | 1 |
| IrinotecanAlso: Campto®, Camptosar®, irinotecan hydrochlorideintravenous injection | Drug | 1 |
Primary outcome
The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan
Time frame: assessed after each course of treatment
1 secondary outcome
To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762.
Time frame: assessed after each course of treatment
Results and safety
The study was stopped early (reason given: Termination of the study was made after a full review of program data and assessment of the current risk-benefit profile.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
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Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
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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.
Peter Langmuir, MD study director
AstraZeneca
3 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 AZD7762 and Irinotecan in people with Advanced Solid Tumors and Cancer, run by AstraZeneca at 3 sites in United States.
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 4 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 11 Feb 2011. 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 States. 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: Termination of the study was made after a full review of program data and assessment of the current risk-benefit profile.). 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?
The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan (time frame: assessed after each course of treatment). 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 11 Feb 2011.