NeoplasmsPhase 1NCT00475956
Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours
A Phase 1 study testing AZD2171 and AZD0530 in people with Neoplasms, run by AstraZeneca at 3 sites in Germany.
Trial summary
The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- AZD2171 and AZD0530
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesGermany
- Study dates
- May 2007to Oct 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
- Written consent
- Cancer diagnosis \& stage
- Patients for whom no standard therapy exists
- World Health Organization (WHO) performance status 0-2
- One or more measurable lesions
Who cannot join
- Prostate cancer
- Untreated unstable brain or meningeal metastases
- Specific laboratory ranges
- Pregnant or breast-feeding women
- Any evidence of severe or uncontrolled diseases
- Participation in other trials within 30 days
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Research Site
Essen, Ruhr
Research Site
Freiburg im Breisgau, Baden-Wurttemberg
Research Site
Herne, Ruhr
About this study
Official title: Phase I, Open-Label Study To Assess the Safety, Tolerability and Pharmacokinetics of Daily Oral Doses of Cediranib (RECENTIN™;AZD2171) (20, 30 or 45mg) When Co-Administered With Daily Oral Doses of AZD0530 (125mg or 175mg) in Patients With Advanced Solid Tumours
The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.
- Conditions
- Neoplasms
- Being tested
- AZD2171, AZD0530
- Keywords
- Cancer, Tumour, Advanced Solid Tumour, Lung Cancer, Breast Cancer, Cholangiocarcinoma, Colon Cancer, Gastric Cancer, Choriocarcinoma, Liver Cancer, Myeloma, Ovarian Cancer, Pancreatic Cancer, Peritoneal Cancer
- Medical subject headings
- Neoplasms, Lung Neoplasms, Breast Neoplasms, Cholangiocarcinoma, Colonic Neoplasms, Stomach Neoplasms, Choriocarcinoma, Liver Neoplasms
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 multiple ascending doses 20, 30 or 45 mg
AZD0530Drug
oral tablet multiple ascending doses 125 mg or 175 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD2171 Monotherapy Receives: Drug: AZD2171 |
| 2 | Experimental | AZD2171 + AZD0530 Receives: Drug: AZD2171; Drug: AZD0530 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety and tolerability of ascending daily oral doses of AZD2171 when co-administered with AZD0530 to patients with advanced solid tumours by assessment of AEs, vital signs, HRCT Scans, clin chem, haematology, urinalysis, ECG and phys exam
Measured: assessed at each visit
Secondary outcomes (3)
Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530
Measured: assessed at each visit
Safety and efficacy
Measured: assessed at each visit
Genetic variation of pathways targeted by AZD2171 and AZD0530
Measured: assessed during study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startMay 2007
- Primary completionOct 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jane Roberston, Study director, AstraZenecaTanja Trarbach, MD, Principal investigator, Universitatsklinikum der GHS Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475956
- Sponsor's protocol ID
- D8480C00014
- Other IDs
- EuDract #2006-003505-55
- Status last verified
- Apr 2010
- First submitted
- 18 May 2007
- Last updated
- 15 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-Label Study To Assess the Safety, Tolerability and Pharmacokinetics of Daily Oral Doses of Cediranib (RECENTIN™;AZD2171) (20, 30 or 45mg) When Co-Administered With Daily Oral Doses of AZD0530 (125mg or 175mg) in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT00475956
- Acronym / sponsor ID
- D8480C00014
- Conditions
- Neoplasms
- Keywords
- Cancer, Tumour, Advanced Solid Tumour, Lung Cancer, Breast Cancer, Cholangiocarcinoma, Colon Cancer, Gastric Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 21 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.
The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD2171AZD2171 Monotherapy |
| 2 | Experimental | Drug: AZD2171, Drug: AZD0530AZD2171 + AZD0530 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written consent
- Cancer diagnosis \& stage
- Patients for whom no standard therapy exists
- World Health Organization (WHO) performance status 0-2
- One or more measurable lesions
Key exclusion criteria (6 listed)
- Prostate cancer
- Untreated unstable brain or meningeal metastases
- Specific laboratory ranges
- Pregnant or breast-feeding women
- Any evidence of severe or uncontrolled diseases
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 multiple ascending doses 20, 30 or 45 mg | Drug | 1, 2 |
| AZD0530oral tablet multiple ascending doses 125 mg or 175 mg | Drug | 2 |
Primary outcome
Determine the safety and tolerability of ascending daily oral doses of AZD2171 when co-administered with AZD0530 to patients with advanced solid tumours by assessment of AEs, vital signs, HRCT Scans, clin chem, haematology, urinalysis, ECG and phys exam
Time frame: assessed at each visit
3 secondary outcomes
Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530
Time frame: assessed at each visit
Safety and efficacy
Time frame: assessed at each visit
Genetic variation of pathways targeted by AZD2171 and AZD0530
Time frame: assessed during study
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 15 Apr 2010.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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 Roberston study director
AstraZeneca
Tanja Trarbach, MD principal investigator
Universitatsklinikum der GHS Essen
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 and AZD0530 in people with Neoplasms, run by AstraZeneca at 3 sites in Germany.
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 5 inclusion and 6 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 15 Apr 2010. 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 Germany. 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 ascending daily oral doses of AZD2171 when co-administered with AZD0530 to patients with advanced solid tumours by assessment of AEs, vital signs, HRCT Scans, clin chem, haematology, urinalysis, ECG and phys exam (time frame: assessed at each visit). 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 15 Apr 2010.