CancerPhase 1NCT00937664
Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine
A Phase 1 study testing AZD7762 and gemcitabine in people with Cancer and Solid Tumors, run by AstraZeneca at 1 site in Japan.
Trial summary
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Cancer, Solid Tumors, Advanced Solid Malignancies
- What is being tested?
- AZD7762 and gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2009to Feb 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective.
- Must be suitable for treatment with gemcitabine
- Relatively good overall health other than cancer
Who cannot join
- Poor bone marrow function (not producing enough blood cells).
- Poor liver or kidney function.
- Serious heart conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.
- Conditions
- Cancer, Solid Tumors, Advanced Solid Malignancies
- Being tested
- AZD7762, gemcitabine
- Keywords
- Phase I, cancer, solid tumors, advanced solid malignancies, dose escalation, combination treatment, CHK inhibitor, Japanese
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7762Drug
solution, intravenous, weekly
gemcitabineDrug
Also called Gemzar
intravenous, weekly
| Study group | Role | What they receive |
|---|---|---|
| AZD7762 + gemcitabine | Other | AZD7762 administered alone and in combination with gemcitabine Receives: Drug: AZD7762; Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram
Measured: Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2
Secondary outcomes (2)
Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine
Measured: According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1
Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Every 2-3 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
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 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Langmuir, MD, Study director, AstraZenecaTakashi Seto, MD, PhD, Principal investigator, National Hospital Organization Kyushu Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937664
- Sponsor's protocol ID
- D1040C00008
- Status last verified
- Feb 2011
- First submitted
- 9 Jul 2009
- Last updated
- 7 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00937664
- Acronym / sponsor ID
- D1040C00008
- Conditions
- Cancer, Solid Tumors, Advanced Solid Malignancies
- Keywords
- Phase I, cancer, solid tumors, advanced solid malignancies, dose escalation, combination treatment, CHK inhibitor, Japanese
- 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
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 13 Jul 2009 (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 study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD7762 + gemcitabine | Other | Drug: AZD7762, Drug: gemcitabineAZD7762 administered alone and in combination with gemcitabine |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective.
- Must be suitable for treatment with gemcitabine
- Relatively good overall health other than cancer
Key exclusion criteria (3 listed)
- Poor bone marrow function (not producing enough blood cells).
- Poor liver or kidney function.
- Serious heart 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 |
|---|---|---|
| AZD7762solution, intravenous, weekly | Drug | AZD7762 + gemcitabine |
| gemcitabineAlso: Gemzarintravenous, weekly | Drug | AZD7762 + gemcitabine |
Primary outcome
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram
Time frame: Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2
2 secondary outcomes
Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine
Time frame: According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1
Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Every 2-3 cycles
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 7 Feb 2011.
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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
Takashi Seto, MD, PhD principal investigator
National Hospital Organization Kyushu Cancer Center
1 site 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 gemcitabine in people with Cancer and Solid Tumors, run by AstraZeneca at 1 site in Japan.
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: stopped early, as of the sponsor's last update on 7 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 1 site in 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?
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?
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram (time frame: Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2). 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 7 Feb 2011.