CancerPhase 1NCT00650572
A Study of ARRY-380 in Patients With Advanced HER2+ Cancer
A Phase 1 study testing ARRY-380, HER2 inhibitor; oral in people with Cancer, run by Seagen Inc. at 4 sites in 2 countries.
Trial summary
This is a Phase 1 study during which patients with advanced HER2+ solid malignancies or HER2+ metastatic breast cancer will receive investigational study drug ARRY-380. This study has 2 parts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- ARRY-380, HER2 inhibitor; oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2008to Mar 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological evidence of HER2+ cancer (Part 1) or HER2+ metastatic breast cancer (Part 2).
- Patients should have received at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy (patients with HER2+ breast cancer and with clinical indication for trastuzumab or lapatinib should have received prior therapy with trastuzumab and lapatinib, if available).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.
- Additional criteria exist.
Who cannot join
- Uncontrolled or symptomatic brain metastases (patients may be considered adequately controlled if on a stable steroid dose for at least 30 days).
- Treatment with an investigational medicinal product or device within 30 days prior to first dose of study drug.
- Radiotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
- Chemotherapy within 21 days prior to first dose of study drug.
- Major surgery within 30 days prior to first dose of study drug.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
- Additional criteria exist.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
The University of Colorado Cancer Center
Aurora, Colorado
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77230
Canada2 sites
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
This is a Phase 1 study during which patients with advanced HER2+ solid malignancies or HER2+ metastatic breast cancer will receive investigational study drug ARRY-380.
This study has 2 parts. In the first part, patients with advanced HER2+ solid malignancies, who have already received at least one previous standard therapy, will receive increasing doses of study drug in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Completed).
In the second part of this study, patients with HER2+ metastatic breast cancer, who have already received at least one previous standard therapy, will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 20 patients from the US will be enrolled in Part 2 (Active, not recruiting).
- Conditions
- Cancer
- Being tested
- ARRY-380, HER2 inhibitor; oral
- Keywords
- human epidermal growth factor receptor 2, epidermal growth factor receptor, EGFR, type I receptor tyrosine kinase
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARRY-380, HER2 inhibitor; oralDrug
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
| Study group | Role | What they receive |
|---|---|---|
| ARRY-380 | Experimental | Not described Receives: Drug: ARRY-380, HER2 inhibitor; oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Measured: Part 1, one year; Part 2, one year
Establish the maximum tolerated dose (MTD) of the study drug.
Measured: Part 1, one year
Characterize the pharmacokinetics of the study drug.
Measured: Part 2, one year
Assess amplification/expression of HER2 in archival and tumor tissues.
Measured: Part 2, one year
Secondary outcomes (4)
Characterize the pharmacokinetics of the study drug.
Measured: Part 1, one year
Assess changes in tumor markers.
Measured: Part 1, one year
Assess the efficacy of study drug in terms of tumor response and duration of response.
Measured: Part 1, one year; Part 2, one year
Assess expression of growth factor pathway proteins in archival and tumor tissues.
Measured: Part 2, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Array BioPharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650572
- Sponsor's protocol ID
- ARRAY-380-101
- Status last verified
- May 2020
- First submitted
- 31 Mar 2008
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ARRY-380 in Patients With Advanced HER2+ Cancer
- ClinicalTrials.gov ID
- NCT00650572
- Acronym / sponsor ID
- ARRAY-380-101
- Conditions
- Cancer
- Keywords
- human epidermal growth factor receptor 2, epidermal growth factor receptor, EGFR, type I receptor tyrosine kinase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Array BioPharma
- Study start
- May 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Apr 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 is a Phase 1 study during which patients with advanced HER2+ solid malignancies or HER2+ metastatic breast cancer will receive investigational study drug ARRY-380.
This study has 2 parts. In the first part, patients with advanced HER2+ solid malignancies, who have already received at least one previous standard therapy, will receive increasing doses of study drug in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Completed).
In the second part of this study, patients with HER2+ metastatic breast cancer, who have already received at least one previous standard therapy, will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 20 patients from the US will be enrolled in Part 2 (Active, not recruiting).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARRY-380 | Experimental | Drug: ARRY-380, HER2 inhibitor; oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histological or cytological evidence of HER2+ cancer (Part 1) or HER2+ metastatic breast cancer (Part 2).
- Patients should have received at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy (patients with HER2+ breast cancer and with clinical indication for trastuzumab or lapatinib should have received prior therapy with trastuzumab and lapatinib, if available).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.
- Additional criteria exist.
Key exclusion criteria (7 listed)
- Uncontrolled or symptomatic brain metastases (patients may be considered adequately controlled if on a stable steroid dose for at least 30 days).
- Treatment with an investigational medicinal product or device within 30 days prior to first dose of study drug.
- Radiotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
- Chemotherapy within 21 days prior to first dose of study drug.
- Major surgery within 30 days prior to first dose of study drug.
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 |
|---|---|---|
| ARRY-380, HER2 inhibitor; oralPart 1: multiple dose, escalating; Part 2: multiple dose, single schedule. | Drug | ARRY-380 |
Primary outcome
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: Part 1, one year; Part 2, one year
Establish the maximum tolerated dose (MTD) of the study drug.
Time frame: Part 1, one year
Characterize the pharmacokinetics of the study drug.
Time frame: Part 2, one year
Assess amplification/expression of HER2 in archival and tumor tissues.
Time frame: Part 2, one year
4 secondary outcomes
Characterize the pharmacokinetics of the study drug.
Time frame: Part 1, one year
Assess changes in tumor markers.
Time frame: Part 1, one year
Assess the efficacy of study drug in terms of tumor response and duration of response.
Time frame: Part 1, one year; Part 2, one year
Assess expression of growth factor pathway proteins in archival and tumor tissues.
Time frame: Part 2, one year
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 7 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARRY-380, HER2 inhibitor; oral in people with Cancer, run by Seagen Inc. at 4 sites in 2 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 4 inclusion and 7 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 7 May 2020. 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, Canada. 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?
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. (time frame: Part 1, one year; Part 2, one year). The study lists 4 primary outcomes in all. 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 7 May 2020.