Advanced CancerPhase 1/2NCT00862524
A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic Cancer
A Phase 1/2 study testing ARRY-334543, EGFR/ErbB2 inhibitor; oral and Gemcitabine, nucleoside analogue; intravenous in people with Advanced Cancer and Pancreatic Cancer, run by Array BioPharma at 6 sites in United States.
Trial summary
This is a 2-phase study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and gemcitabine. The study has 2 parts. In the first part of the study, Phase 1, patients with advanced/metastatic solid tumors will receive increasing doses of study drug in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Pancreatic Cancer
- What is being tested?
- ARRY-334543, EGFR/ErbB2 inhibitor; oral and Gemcitabine, nucleoside analogue; intravenous
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2009to Feb 2011
- Phase
- Phase 1/2
- 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 a solid tumor suitable for treatment with gemcitabine.
- No more than 3 prior anticancer regimens for advanced disease.
- Measurable or evaluable, nonmeasurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Able to take and retain oral medications.
- 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 have been stable for at least 30 days).
- Treatment with prior chemotherapy within 21 days of first dose of study drug.
- Requiring IV alimentation.
- Pregnancy or lactation.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
- History of being unable to tolerate gemcitabine or any of its components.
- Additional criteria exist.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado Health Sciences Center
Aurora, Colorado, 80045
Partners, Massachusetts General Hospital
Boston, Massachusetts, 02114
Partners, Dana Farber
Boston, Massachusetts, 02115
Sarah Cannon Research Center
Nashville, Tennessee, 37203
Pinnacle Oncology/Hematology
Phoenix, Arizona, 85258
Premiere Oncology
Santa Monica, California, 90404-2111
About this study
This is a 2-phase study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and gemcitabine.
The study has 2 parts. In the first part of the study, Phase 1, patients with advanced/metastatic solid tumors will receive increasing doses of study drug in combination with gemcitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 24 patients from the US will be enrolled in Part 1 (Completed).
In the second part of the study, Phase 2, patients with metastatic pancreatic cancer will receive the best dose of study drug, in combination with gemcitabine, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).
- Conditions
- Advanced Cancer, Pancreatic Cancer
- Being tested
- ARRY-334543, EGFR/ErbB2 inhibitor; oral, Gemcitabine, nucleoside analogue; intravenous
- Medical subject headings
- Pancreatic Neoplasms
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
multiple dose, escalating
Gemcitabine, nucleoside analogue; intravenousDrug
multiple dose, single schedule
| Study group | Role | What they receive |
|---|---|---|
| ARRY-334543 + gemcitabine | Experimental | Not described Receives: Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral; Drug: Gemcitabine, nucleoside analogue; intravenous |
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 in combination with gemcitabine.
Measured: Part 1
Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.
Measured: Part 1
Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite.
Measured: Part 1
Assess the efficacy of the study drug in combination with gemcitabine in terms of progression-free survival (PFS) at 16 weeks.
Measured: Part 2
Secondary outcomes (2)
Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response.
Measured: Part 1
Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.
Measured: Part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2011
- Study completionFeb 2011
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Array BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862524
- Sponsor's protocol ID
- ARRAY-543-206
- Status last verified
- Sep 2012
- First submitted
- 16 Mar 2009
- Last updated
- 4 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00862524
- Acronym / sponsor ID
- ARRAY-543-206
- Conditions
- Advanced Cancer, Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Array BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 17 Mar 2009 (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 2-phase study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and gemcitabine.
The study has 2 parts. In the first part of the study, Phase 1, patients with advanced/metastatic solid tumors will receive increasing doses of study drug in combination with gemcitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 24 patients from the US will be enrolled in Part 1 (Completed).
In the second part of the study, Phase 2, patients with metastatic pancreatic cancer will receive the best dose of study drug, in combination with gemcitabine, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).
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 + gemcitabine | Experimental | Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral, Drug: Gemcitabine, nucleoside analogue; intravenous |
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 a solid tumor suitable for treatment with gemcitabine.
- No more than 3 prior anticancer regimens for advanced disease.
- Measurable or evaluable, nonmeasurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Able to take and retain oral medications.
Key exclusion criteria (7 listed)
- Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days).
- Treatment with prior chemotherapy within 21 days of first dose of study drug.
- Requiring IV alimentation.
- Pregnancy or lactation.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
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; oralmultiple dose, escalating | Drug | ARRY-334543 + gemcitabine |
| Gemcitabine, nucleoside analogue; intravenousmultiple dose, single schedule | Drug | ARRY-334543 + gemcitabine |
Primary outcome
Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine.
Time frame: Part 1
Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: Part 1
Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite.
Time frame: Part 1
Assess the efficacy of the study drug in combination with gemcitabine in terms of progression-free survival (PFS) at 16 weeks.
Time frame: Part 2
2 secondary outcomes
Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response.
Time frame: Part 1
Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: 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 4 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ARRY-334543, EGFR/ErbB2 inhibitor; oral and Gemcitabine, nucleoside analogue; intravenous in people with Advanced Cancer and Pancreatic Cancer, run by Array BioPharma at 6 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 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 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 in combination with gemcitabine. (time frame: Part 1). 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 4 Oct 2012.