Cancer,Phase 1NCT00733031
Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918
A Phase 1 study testing AZD6918, gemcitabine and pemetrexed in people with Cancer, and Solid Tumors, run by AstraZeneca at 2 sites in United States.
Trial summary
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer,, Solid Tumors, Advanced Solid Malignancies
- What is being tested?
- AZD6918, gemcitabine and pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Mar 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
- Advanced solid tumors for which standard treatment does not exist or is no longer effective.
- For chemotherapy combination treatment, must be suitable for treatment with either gemcitabine or pemetrexed.
- 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
- History of uncontrolled epilepsy, Parkinson's disease, Alzheimer's disease, brain tumor or any uncontrolled psychiatric or nervous system condition
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Aurora, Colorado
Research Site
Nashville, Tennessee
About this study
Official title: A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6918 Administered Daily as a Single Agent and in Combination Treatment in Adult Patients With Refractory Solid Malignancies
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.
- Conditions
- Cancer,, Solid Tumors, Advanced Solid Malignancies
- Being tested
- AZD6918, gemcitabine, pemetrexed
- Keywords
- Phase I,, cancer,, solid tumors,, advanced solid malignancies,, dose escalation,, combination treatment,, TRK inhibitor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6918Drug
liquid suspension, daily, oral dose
gemcitabineDrug
Also called Gemzar
intravenous, doses are on an intermittent schedule
pemetrexedDrug
Also called Alimta
intravenous, dose administered every 21-days
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine | Experimental | gemcitabine administered in combination with AZD6918 Receives: Drug: gemcitabine |
| pemetrexed | Experimental | pemetrexed administered in combination with AZD6918 Receives: Drug: pemetrexed |
| AZD6918 | Experimental | AZD6918 administered alone Receives: Drug: AZD6918 |
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, Karnofsky performance status
Measured: Weekly for first two treatment cycles, then every 2-4 weeks
Secondary outcomes (1)
Pharmacokinetic effect of AZD6918 when administered alone and in combination with chemotherapy
Measured: According to protocol specified schedule, the number of PK samples collected during Cycle 1 (up to 28 days) based on treatment with AZD6918 alone or in combination with chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: PK results demonstrate low and variable plasma concentrations so that achieving therapeutic concentrations is unlikely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer,Studies 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Judith Ochs, MD, Study director, AstraZenecaJeffrey Infante, MD, Principal investigator, SCRI Development Innovations, LLCLia Gore, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733031
- Sponsor's protocol ID
- D2785C00002
- Status last verified
- Dec 2010
- First submitted
- 8 Aug 2008
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. 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 the Safety, Tolerability and Pharmacokinetics of AZD6918 Administered Daily as a Single Agent and in Combination Treatment in Adult Patients With Refractory Solid Malignancies
- ClinicalTrials.gov ID
- NCT00733031
- Acronym / sponsor ID
- D2785C00002
- Conditions
- Cancer,, Solid Tumors, Advanced Solid Malignancies
- Keywords
- Phase I,, cancer,, solid tumors,, advanced solid malignancies,, dose escalation,, combination treatment,, TRK inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PK results demonstrate low and variable plasma concentrations so that achieving therapeutic concentrations is unlikely.
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 Aug 2008 (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 AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| gemcitabine | Experimental | Drug: gemcitabinegemcitabine administered in combination with AZD6918 |
| pemetrexed | Experimental | Drug: pemetrexedpemetrexed administered in combination with AZD6918 |
| AZD6918 | Experimental | Drug: AZD6918AZD6918 administered alone |
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 does not exist or is no longer effective.
- For chemotherapy combination treatment, must be suitable for treatment with either gemcitabine or pemetrexed.
- Relatively good overall health other than cancer.
Key exclusion criteria (4 listed)
- Poor bone marrow function (not producing enough blood cells).
- Poor liver or kidney function.
- Serious heart conditions
- History of uncontrolled epilepsy, Parkinson's disease, Alzheimer's disease, brain tumor or any uncontrolled psychiatric or nervous system condition
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 |
|---|---|---|
| AZD6918liquid suspension, daily, oral dose | Drug | AZD6918 |
| gemcitabineAlso: Gemzarintravenous, doses are on an intermittent schedule | Drug | gemcitabine |
| pemetrexedAlso: Alimtaintravenous, dose administered every 21-days | Drug | pemetrexed |
Primary outcome
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, Karnofsky performance status
Time frame: Weekly for first two treatment cycles, then every 2-4 weeks
1 secondary outcome
Pharmacokinetic effect of AZD6918 when administered alone and in combination with chemotherapy
Time frame: According to protocol specified schedule, the number of PK samples collected during Cycle 1 (up to 28 days) based on treatment with AZD6918 alone or in combination with chemotherapy
Results and safety
The study was stopped early (reason given: PK results demonstrate low and variable plasma concentrations so that achieving therapeutic concentrations is unlikely.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
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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.
Judith Ochs, MD study director
AstraZeneca
Jeffrey Infante, MD principal investigator
SCRI Development Innovations, LLC
Lia Gore, MD principal investigator
University of Colorado, Denver
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 AZD6918, gemcitabine and pemetrexed in people with Cancer, and Solid Tumors, run by AstraZeneca at 2 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 10 Dec 2010. 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 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: PK results demonstrate low and variable plasma concentrations so that achieving therapeutic concentrations is unlikely.). 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, Karnofsky performance status (time frame: Weekly for first two treatment cycles, then every 2-4 weeks). 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 10 Dec 2010.