Advanced Solid TumorPhase 1NCT00502567
A Study to Assess Safety, Tolerability and PK of AZD2171 and Chemotherapy on Patients With Solid Tumors
A Phase 1 study testing AZD2171, FOLFOX and Pemetrexed in people with Advanced Solid Tumor, run by AstraZeneca at 3 sites in United States.
Trial summary
A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of AZD2171 when administered with various anticancer regimens (part A) and to confirm the tolerability of its combination with FOLFOX (part B). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- AZD2171, FOLFOX and Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 104 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2005to Jun 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
- histologically confirmed metastatic cancer that is not amenable to surgery or radiation therapy with curative intent
- measurable lesion by CT or other techniques according to RECIST
Who cannot join
- Inadequate bone marrow reserve
- history of poorly controlled hypertension
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Ann Arbor, Michigan
Research Site
Detroit, Michigan
Research Site
Nashville, Tennessee
About this study
Official title: A Phase 1, Open Label Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2171 and Selected Chemotherapy Regimens When Given in Combination to Patients With Advanced Solid Tumors
A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of AZD2171 when administered with various anticancer regimens (part A) and to confirm the tolerability of its combination with FOLFOX (part B).
- Conditions
- Advanced Solid Tumor
- Being tested
- AZD2171, FOLFOX, Pemetrexed, Irinotecan (administered with & without Cetuximab), Docetaxel
- Keywords
- advanced solid tumors, AZD2171, Phase I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2171Drug
Also called cediranib, RECENTIN™.
oral tablet once daily
FOLFOXDrug
Also called 5-Fluorouracil, Leucovorin and Oxaliplatin
intravenous infusion
PemetrexedDrug
Also called Alimta®, Pemetrexed disodium
intravenous infusion
Irinotecan (administered with & without Cetuximab)Drug
Also called Campto®, Camptosar®, irinotecan hydrochloride
intravenous injection
DocetaxelDrug
Also called Taxotere®
intravenous infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety and tolerability of once daily oral doses of AZD2171 when given in combination with one of these anticancer regimens; FOLFOX, Pemetrexed, Irinotecan, Docetaxel
Measured: After 5 weeks of treatment
Secondary outcomes (1)
Examine the PK interaction of AZD2171 with one of the 4 different chemotherapeutic regimens. Make a preliminary evaluation of clinical response as measured by objective response rate.
Measured: Assessed at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startJan 2005
- Primary completionNov 2007
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jane Robertson, Study director, AstraZenecaBijoyesh Mookerjee, MD, Study chair, AstraZenecaPatricia LoRusso, DO, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502567
- Sponsor's protocol ID
- D8480C00008
- Status last verified
- Jul 2011
- First submitted
- 16 Jul 2007
- Last updated
- 27 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2171 and Selected Chemotherapy Regimens When Given in Combination to Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00502567
- Acronym / sponsor ID
- D8480C00008
- Conditions
- Advanced Solid Tumor
- Keywords
- advanced solid tumors, AZD2171, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 17 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.
A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of AZD2171 when administered with various anticancer regimens (part A) and to confirm the tolerability of its combination with FOLFOX (part B).
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)
- histologically confirmed metastatic cancer that is not amenable to surgery or radiation therapy with curative intent
- measurable lesion by CT or other techniques according to RECIST
Key exclusion criteria (2 listed)
- Inadequate bone marrow reserve
- history of poorly controlled hypertension
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 |
|---|---|---|
| AZD2171Also: cediranib, RECENTIN™.oral tablet once daily | Drug | – |
| FOLFOXAlso: 5-Fluorouracil, Leucovorin and Oxaliplatinintravenous infusion | Drug | – |
| PemetrexedAlso: Alimta®, Pemetrexed disodiumintravenous infusion | Drug | – |
| Irinotecan (administered with & without Cetuximab)Also: Campto®, Camptosar®, irinotecan hydrochlorideintravenous injection | Drug | – |
| DocetaxelAlso: Taxotere®intravenous infusion | Drug | – |
Primary outcome
Determine the safety and tolerability of once daily oral doses of AZD2171 when given in combination with one of these anticancer regimens; FOLFOX, Pemetrexed, Irinotecan, Docetaxel
Time frame: After 5 weeks of treatment
1 secondary outcome
Examine the PK interaction of AZD2171 with one of the 4 different chemotherapeutic regimens. Make a preliminary evaluation of clinical response as measured by objective response rate.
Time frame: Assessed at each visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 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.
Jane Robertson study director
AstraZeneca
Bijoyesh Mookerjee, MD study chair
AstraZeneca
Patricia LoRusso, DO principal investigator
Wayne State University
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 AZD2171, FOLFOX and Pemetrexed in people with Advanced Solid Tumor, 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 2 inclusion and 2 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 27 Jul 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the safety and tolerability of once daily oral doses of AZD2171 when given in combination with one of these anticancer regimens; FOLFOX, Pemetrexed, Irinotecan, Docetaxel (time frame: After 5 weeks 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 27 Jul 2011.