Breast NeoplasmPhase 1CHIVENCT01596530
Evaluation of Drug Activity in Women With Breast Cancer and no Previous Herceptin Treatment
A Phase 1 study testing Drug-AZD8931 in people with Breast Neoplasm, run by AstraZeneca at 7 sites in 3 countries.
Trial summary
To compare the activity of AZD8931 against placebo on the cell markers in cancer tumours Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Drug-AZD8931
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jun 2012to May 2013
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged 18 or older Early stage breast cancer and planned surgery
- Ineligible for Trastuzumab (Herceptin) treatment as per local guidelines
- World health Organisation performance status of 0 to 1 Tumour size amenable to obtaining adequate biopsies pre dosing.
Who cannot join
- Eligible for Trastuzumab (Herceptin) Treatment Known sensitivity to AZD8931, its excipients or drugs in its class;
- Including oral tyrosine kinase inhibitors History of eye conditions e.g. previous injury within 3 months or clinically significant eye disease
- Concurrent malignancy Unable to discontinue medication or herbal supplement known to inhibit CYP3A4 or CYP2D6
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany3 sites
Research Site
Düsseldorf
Research Site
Essen
Research Site
Wittenberg
About this study
Official title: A Randomised Double-Blind Placebo-controlled Multicentre Phase I Study to Assess the Biological Activity of AZD8931 in Patients With Early Breast Cancer Who Are Ineligible for Treatment With Trastuzumab as Defined by IHC Status
To compare the activity of AZD8931 against placebo on the cell markers in cancer tumours
Read the detailed description
A Randomised Double-Blind Placebo-controlled Multicentre Phase I Study to Assess the Biological Activity of AZD8931 in Patients with Early Breast Cancer who are Ineligible for Treatment with trastuzumab as defined by IHC status
- Conditions
- Breast Neoplasm
- Being tested
- Drug-AZD8931, Drug-Placebo
- Keywords
- Breast Neoplasm, Breast Cancer, Breast Tumour, Cancer of Breast, Cancer of the Breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-AZD8931Drug
Active drug for biological activity
Drug-PlaceboDrug
Placebo comparator for biological activity comparison
| Study group | Role | What they receive |
|---|---|---|
| AZD8931 | Active comparator | AZD8931 Receives: Drug: Drug-AZD8931 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Drug-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the effects of AZD8931 versus placebo on cytoplasmic p-MAPK after 7 days or more days of treatment
Measured: Day 7 - Day 14
Secondary outcomes (7)
Comparison of the effects of AZD8931 versus placebo on p-EGFR, p-erbB2, p-erbB3 NUCLEAR p-Mapk, p-AKT and Ki67 after 7 or more days of treatment
Measured: Day 7 - Day 14
Assessment sof the safety and tolerability of AZD8931 as assessed by incidence of adverse events during the course of the study.
Measured: From study entry through to 30 days post treatment (Day 44 maximum)
Assessment of the plasma PK of AZD8931
Measured: Day 1 - Day 14
Comparison of the effects of AZD8931 versus placebo on other biomarkers including but not limited to, erbB ligands, pER, PTEN, erbB receptor homo- and hetero- dimers, total MAPK, apoptosis markers and total AKT after 7 or more days of treatment.
Measured: Day 7 - Day 14
Establishing the baseline tumour characteristics, including but not limited to ER, PR and HER-2 status
Measured: Day -28 to Day 0
Exploration of the relationship between AZD8931 exposure (PK in plasma and tumour) and a selection of secondary biomarkers (e.g. p-EGFR, nuclear p-MAPK, Ki67 and apoptosis markers after ?7 days of treatment), if possible.
Measured: Day 1 - Day 14
Change from baseline in laboratory, vitals signs and ECG data
Measured: Day 1 - Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2013 (estimated)
- Study completionMay 2013 (estimated)
Why it stopped: All AstraZeneca sponsored clinical trials of AZD8931 have been halted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Serban Ghiorghiu, M.D., Study director, Internal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596530
- Sponsor's protocol ID
- D0102C00019
- Acronym
- CHIVE
- Status last verified
- Dec 2012
- First submitted
- 27 Apr 2012
- Last updated
- 17 Dec 2012
- Results posted
- 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 Randomised Double-Blind Placebo-controlled Multicentre Phase I Study to Assess the Biological Activity of AZD8931 in Patients With Early Breast Cancer Who Are Ineligible for Treatment With Trastuzumab as Defined by IHC Status
- ClinicalTrials.gov ID
- NCT01596530
- Acronym / sponsor ID
- CHIVE / D0102C00019
- Conditions
- Breast Neoplasm
- Keywords
- Breast Neoplasm, Breast Cancer, Breast Tumour, Cancer of Breast, Cancer of the Breast
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All AstraZeneca sponsored clinical trials of AZD8931 have been halted
- Enrolment
- 3 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 11 May 2012 (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.
To compare the activity of AZD8931 against placebo on the cell markers in cancer tumours
Detailed description
A Randomised Double-Blind Placebo-controlled Multicentre Phase I Study to Assess the Biological Activity of AZD8931 in Patients with Early Breast Cancer who are Ineligible for Treatment with trastuzumab as defined by IHC status
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD8931 | Active comparator | Drug: Drug-AZD8931AZD8931 |
| Placebo | Placebo comparator | Drug: Drug-PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females aged 18 or older Early stage breast cancer and planned surgery
- Ineligible for Trastuzumab (Herceptin) treatment as per local guidelines
- World health Organisation performance status of 0 to 1 Tumour size amenable to obtaining adequate biopsies pre dosing.
Key exclusion criteria (3 listed)
- Eligible for Trastuzumab (Herceptin) Treatment Known sensitivity to AZD8931, its excipients or drugs in its class;
- Including oral tyrosine kinase inhibitors History of eye conditions e.g. previous injury within 3 months or clinically significant eye disease
- Concurrent malignancy Unable to discontinue medication or herbal supplement known to inhibit CYP3A4 or CYP2D6
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 |
|---|---|---|
| Drug-AZD8931Active drug for biological activity | Drug | AZD8931 |
| Drug-PlaceboPlacebo comparator for biological activity comparison | Drug | Placebo |
Primary outcome
Comparison of the effects of AZD8931 versus placebo on cytoplasmic p-MAPK after 7 days or more days of treatment
Time frame: Day 7 - Day 14
7 secondary outcomes
Comparison of the effects of AZD8931 versus placebo on p-EGFR, p-erbB2, p-erbB3 NUCLEAR p-Mapk, p-AKT and Ki67 after 7 or more days of treatment
Time frame: Day 7 - Day 14
Assessment sof the safety and tolerability of AZD8931 as assessed by incidence of adverse events during the course of the study.
Time frame: From study entry through to 30 days post treatment (Day 44 maximum)
Assessment of the plasma PK of AZD8931
Time frame: Day 1 - Day 14
Comparison of the effects of AZD8931 versus placebo on other biomarkers including but not limited to, erbB ligands, pER, PTEN, erbB receptor homo- and hetero- dimers, total MAPK, apoptosis markers and total AKT after 7 or more days of treatment.
Time frame: Day 7 - Day 14
Establishing the baseline tumour characteristics, including but not limited to ER, PR and HER-2 status
Time frame: Day -28 to Day 0
Exploration of the relationship between AZD8931 exposure (PK in plasma and tumour) and a selection of secondary biomarkers (e.g. p-EGFR, nuclear p-MAPK, Ki67 and apoptosis markers after ?7 days of treatment), if possible.
Time frame: Day 1 - Day 14
Change from baseline in laboratory, vitals signs and ECG data
Time frame: Day 1 - Day 14
Results and safety
The study was stopped early (reason given: All AstraZeneca sponsored clinical trials of AZD8931 have been halted). Results are not available in the source record.
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.
Serban Ghiorghiu, M.D. study director
Internal
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Drug-AZD8931 in people with Breast Neoplasm, run by AstraZeneca at 7 sites in 3 countries.
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 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 7 sites in Germany, South Korea, Taiwan. 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. Some participants in this study may receive a placebo. 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: All AstraZeneca sponsored clinical trials of AZD8931 have been halted). 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?
Comparison of the effects of AZD8931 versus placebo on cytoplasmic p-MAPK after 7 days or more days of treatment (time frame: Day 7 - Day 14). 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.