Advanced CancerPhase 1NCT00278902
A Study of ARRY-334543 in Patients With Advanced Cancer
A Phase 1 study testing ARRY-334543, EGFR/ErbB2 inhibitor; oral in people with Advanced Cancer, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 5 sites in 2 countries.
Trial summary
This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-334543. This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible that will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- ARRY-334543, EGFR/ErbB2 inhibitor; oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2006to Jun 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
- Histologically or cytologically confirmed diagnosis of ErbB2+ breast cancer, pancreatic, squamous cell head and neck, hepatocellular, hepatobiliary, glioblastoma, ovarian, prostate, upper GI, colorectal, non small cell lung, or bladder cancer or other relevant cancers if approved in advance by the Sponsor.
- Measurable disease (at least 1 target lesion) according to modified RECIST.
- Failed at least one previous therapeutic regimen and either no longer a candidate for standard therapy, has no standard therapy available, or chooses not to pursue standard therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Must consent to allow the Sponsor access to an archival histological specimen or to have a pre-dose tumor biopsy.
- Additional criteria exist.
Who cannot join
- Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
- Use of an investigational medication or device within 30 days prior to first dose of study drug.
- Major surgery within 30 days prior to first dose of study drug.
- Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
- Pregnancy or lactation.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C. Of note, if a patient has hepatocellular carcinoma, then they may be enrolled even if they are positive for hepatitis B and/or hepatitis C.
- Additional criteria exist.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Sarah Cannon Research Center
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Canada2 sites
British Columbia Cancer Agency- Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-334543.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 70 patients from the US and Canada will be enrolled in Part 1 (Completed).
In the second part of the study, patients will receive the best dose(s) and schedule(s) of study drug determined from the first part of the study and will be followed to see what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from the US and Canada will be enrolled in Part 2 (Completed).
- Conditions
- Advanced Cancer
- Being tested
- ARRY-334543, EGFR/ErbB2 inhibitor; oral
- Keywords
- ErbB2+ Breast Cancer, HER2+ Breast Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARRY-334543, EGFR/ErbB2 inhibitor; oralDrug
Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule
| Study group | Role | What they receive |
|---|---|---|
| ARRY-334543 | Experimental | Not described Receives: Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the maximum tolerated dose (MTD) of study drug.
Measured: Part 1
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Measured: Part 1 and Part 2
Secondary outcomes (2)
Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations.
Measured: Part 1 and Part 2
Assess the efficacy of the study drug in terms of tumor dimension assessment.
Measured: Part 1 and Part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278902
- Sponsor's protocol ID
- ARRY-0501
- Status last verified
- Oct 2020
- First submitted
- 17 Jan 2006
- Last updated
- 14 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ARRY-334543 in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00278902
- Acronym / sponsor ID
- ARRY-0501
- Conditions
- Advanced Cancer
- Keywords
- ErbB2+ Breast Cancer, HER2+ Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 19 Jan 2006 (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 solid tumors will receive investigational study drug ARRY-334543.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 70 patients from the US and Canada will be enrolled in Part 1 (Completed).
In the second part of the study, patients will receive the best dose(s) and schedule(s) of study drug determined from the first part of the study and will be followed to see what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from the US and Canada will be enrolled in Part 2 (Completed).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARRY-334543 | Experimental | Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed diagnosis of ErbB2+ breast cancer, pancreatic, squamous cell head and neck, hepatocellular, hepatobiliary, glioblastoma, ovarian, prostate, upper GI, colorectal, non small cell lung, or bladder cancer or other relevant cancers if approved in advance by the Sponsor.
- Measurable disease (at least 1 target lesion) according to modified RECIST.
- Failed at least one previous therapeutic regimen and either no longer a candidate for standard therapy, has no standard therapy available, or chooses not to pursue standard therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Must consent to allow the Sponsor access to an archival histological specimen or to have a pre-dose tumor biopsy.
Key exclusion criteria (7 listed)
- Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
- Use of an investigational medication or device within 30 days prior to first dose of study drug.
- Major surgery within 30 days prior to first dose of study drug.
- Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
- Pregnancy or lactation.
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-334543, EGFR/ErbB2 inhibitor; oralPart 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule | Drug | ARRY-334543 |
Primary outcome
Establish the maximum tolerated dose (MTD) of study drug.
Time frame: Part 1
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Time frame: Part 1 and Part 2
2 secondary outcomes
Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations.
Time frame: Part 1 and Part 2
Assess the efficacy of the study drug in terms of tumor dimension assessment.
Time frame: Part 1 and Part 2
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 14 Oct 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.
Pfizer CT.gov Call Center study director
Pfizer
5 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-334543, EGFR/ErbB2 inhibitor; oral in people with Advanced Cancer, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 5 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 6 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Establish the maximum tolerated dose (MTD) of study drug. (time frame: Part 1). The study lists 2 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 14 Oct 2020.