Lung CancerPhase 1NCT00621361
Phase I Safety and Tolerability Study of Cediranib (RECENTIN™, AZD2171) in Combination With Chemo in First Line Lung Cancer Patients
A Phase 1 study testing AZD2171, Etoposide and Cisplatin in people with Lung Cancer, run by AstraZeneca at 4 sites in United States.
Trial summary
This study is to assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171)in combination with etoposide and cisplatin (EP) as first line treatment for lung cancer patients with extensive stage or metastatic disease for whom EP would be a standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- AZD2171, Etoposide and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2008to Feb 2012
- 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
- Cancer diagnosis and stage (histological or cytological confirmed extensive stage lung cancer, which EP would be considered a standard therapy, required at the time of diagnosis.)
- No prior chemotherapy or immunotherapy for advanced stage lung cancer (prior radiotherapy will be permitted if it is outside of the measurable field and greater than or equal to 2 weeks prior to entry to the study.)
- WHO performance status 0-2
Who cannot join
- Untreated unstable brain or meningeal metastases
- Patient with inappropriate laboratory tests values
- Inadequate bone marrow reserve.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Research Site
Denver, Colorado
Research Site
Houston, Texas
Research Site
Kansas City, Kansas
Research Site
Sacramento, California
About this study
Official title: A Phase I, Multi-Centre, Open-Label, Dose Selection Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Etoposide and Cisplatin (EP) as First Line Therapy for Lung Cancer Patients With Extensive Stage or Metastatic Disease for Whom EP Would be a Standard Therapy
This study is to assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171)in combination with etoposide and cisplatin (EP) as first line treatment for lung cancer patients with extensive stage or metastatic disease for whom EP would be a standard therapy.
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, AZD2171, cediranib, RECENTIN, etoposide, cisplatin
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2171Drug
Also called Recentin™
Oral
EtoposideDrug
Also called Etopophos®
Intravenous
CisplatinDrug
Also called Platinol
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD2171 |
| 2 | Active comparator | Etoposide + Cisplatin Receives: Drug: Etoposide; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171) in combination with etoposide and cisplatin (EP).
Measured: From date of consent through to data cut-off, 7th August 2009.
Secondary outcomes (1)
Preliminary efficacy assessment of Cediranib in combination with etoposide & cisplatin using available tumor assessment data to assess response rate,duration of response,change in tumor size(only those with measurable disease)& progression free survival
Measured: From date of randomisation through to data cut-off, 7th August 2009.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2009
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Heymach, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621361
- Sponsor's protocol ID
- D8480C00054
- Status last verified
- Dec 2012
- First submitted
- 12 Feb 2008
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-Centre, Open-Label, Dose Selection Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Etoposide and Cisplatin (EP) as First Line Therapy for Lung Cancer Patients With Extensive Stage or Metastatic Disease for Whom EP Would be a Standard Therapy
- ClinicalTrials.gov ID
- NCT00621361
- Acronym / sponsor ID
- D8480C00054
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, AZD2171, cediranib, RECENTIN, etoposide, cisplatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Feb 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.
This study is to assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171)in combination with etoposide and cisplatin (EP) as first line treatment for lung cancer patients with extensive stage or metastatic disease for whom EP would be a standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD2171 |
| 2 | Active comparator | Drug: Etoposide, Drug: CisplatinEtoposide + Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cancer diagnosis and stage (histological or cytological confirmed extensive stage lung cancer, which EP would be considered a standard therapy, required at the time of diagnosis.)
- No prior chemotherapy or immunotherapy for advanced stage lung cancer (prior radiotherapy will be permitted if it is outside of the measurable field and greater than or equal to 2 weeks prior to entry to the study.)
- WHO performance status 0-2
Key exclusion criteria (3 listed)
- Untreated unstable brain or meningeal metastases
- Patient with inappropriate laboratory tests values
- Inadequate bone marrow reserve.
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: Recentin™Oral | Drug | 1 |
| EtoposideAlso: Etopophos®Intravenous | Drug | 2 |
| CisplatinAlso: PlatinolIntravenous | Drug | 2 |
Primary outcome
Assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171) in combination with etoposide and cisplatin (EP).
Time frame: From date of consent through to data cut-off, 7th August 2009.
1 secondary outcome
Preliminary efficacy assessment of Cediranib in combination with etoposide & cisplatin using available tumor assessment data to assess response rate,duration of response,change in tumor size(only those with measurable disease)& progression free survival
Time frame: From date of randomisation through to data cut-off, 7th August 2009.
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 17 Dec 2012.
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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.
John Heymach, MD principal investigator
M.D. Anderson Cancer Center
4 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, Etoposide and Cisplatin in people with Lung Cancer, run by AstraZeneca at 4 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 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: finished, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171) in combination with etoposide and cisplatin (EP). (time frame: From date of consent through to data cut-off, 7th August 2009.). 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 17 Dec 2012.