Advanced CancerPhase 1NCT00710736
A Study of ARRY-334543 and Capecitabine in Patients With Advanced Cancer
A Phase 1 study testing ARRY-334543, EGFR/ErbB2 inhibitor; oral and Capecitabine, 5-fluorouracil prodrug; oral in people with Advanced Cancer, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 4 sites in 2 countries.
Trial summary
This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and capecitabine. Patients will receive increasing doses of study drug in combination with capecitabine in order to achieve the highest dose of study drug possible that will not cause… 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 and Capecitabine, 5-fluorouracil prodrug; oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2008to Apr 2011
- 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 any advanced/metastatic cancer suitable for treatment with capecitabine. Pancreatic cancer is not allowed and patients with gastric or gastroesophageal junction (GEJ) cancer are only eligible if prior treatment did not include a total gastrectomy.
- Target lesions may be in a previously irradiated field only if progression of the lesion has been clearly documented.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Must be able to take and retain oral medications.
- Additional criteria exist.
Who cannot join
- Active concomitant malignancies.
- 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).
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Requiring intravenous (IV) alimentation.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
- Pregnancy or lactation.
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- Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
- Anti-EGFR and/or ErbB2 small molecule targeted therapy or hormonal anticancer therapy within 14 days prior to first dose of study drug.
- History of any hypersensitivity to or intolerance of capecitabine or any of its components, or to fluorouracil or any fluoropyrimidine therapy.
- Additional criteria exist.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Roswell Park Cancer Institute
Buffalo, New York, 14263
Canada2 sites
British Columbia Cancer Agency- Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
About this study
This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and capecitabine. Patients will receive increasing doses of study drug in combination with capecitabine 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 30 patients from the US and Canada will be enrolled in this study.
- Conditions
- Advanced Cancer
- Being tested
- ARRY-334543, EGFR/ErbB2 inhibitor; oral, Capecitabine, 5-fluorouracil prodrug; oral
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
Capecitabine, 5-fluorouracil prodrug; oralDrug
multiple dose, single schedule
| Study group | Role | What they receive |
|---|---|---|
| ARRY-334543 + capecitabine | Experimental | Not described Receives: Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral; Drug: Capecitabine, 5-fluorouracil prodrug; 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 in combination with capecitabine.
Measured: Duration of study
Characterize the safety profile of study drug in combination with capecitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.
Measured: Duration of study
Characterize the pharmacokinetics (PK) of study drug and capecitabine.
Measured: Duration of study
Secondary outcomes (2)
Assess the efficacy of the study drug in combination with capecitabine in terms of tumor response and changes in serological tumor markers.
Measured: Duration of study
Assess potential predictive biomarkers of clinical activity for the study drug in combination with capecitabine.
Measured: Duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2011
- Study completionApr 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 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
- NCT00710736
- Sponsor's protocol ID
- ARRAY-543-204
- Status last verified
- Oct 2020
- First submitted
- 2 Jul 2008
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ARRY-334543 and Capecitabine in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00710736
- Acronym / sponsor ID
- ARRAY-543-204
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 Jul 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/metastatic solid tumors will receive investigational study drug ARRY-334543 and capecitabine. Patients will receive increasing doses of study drug in combination with capecitabine 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 30 patients from the US and Canada will be enrolled in this study.
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 + capecitabine | Experimental | Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral, Drug: Capecitabine, 5-fluorouracil prodrug; oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed diagnosis of any advanced/metastatic cancer suitable for treatment with capecitabine. Pancreatic cancer is not allowed and patients with gastric or gastroesophageal junction (GEJ) cancer are only eligible if prior treatment did not include a total gastrectomy.
- Target lesions may be in a previously irradiated field only if progression of the lesion has been clearly documented.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Must be able to take and retain oral medications.
- Additional criteria exist.
Key exclusion criteria (10 listed)
- Active concomitant malignancies.
- 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).
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Requiring intravenous (IV) alimentation.
- 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 + capecitabine |
| Capecitabine, 5-fluorouracil prodrug; oralmultiple dose, single schedule | Drug | ARRY-334543 + capecitabine |
Primary outcome
Establish the maximum tolerated dose (MTD) of study drug in combination with capecitabine.
Time frame: Duration of study
Characterize the safety profile of study drug in combination with capecitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: Duration of study
Characterize the pharmacokinetics (PK) of study drug and capecitabine.
Time frame: Duration of study
2 secondary outcomes
Assess the efficacy of the study drug in combination with capecitabine in terms of tumor response and changes in serological tumor markers.
Time frame: Duration of study
Assess potential predictive biomarkers of clinical activity for the study drug in combination with capecitabine.
Time frame: Duration of 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 6 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
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-334543, EGFR/ErbB2 inhibitor; oral and Capecitabine, 5-fluorouracil prodrug; oral in people with Advanced Cancer, run by Array Biopharma, now a wholly owned subsidiary of Pfizer 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 5 inclusion and 10 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 6 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 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?
Establish the maximum tolerated dose (MTD) of study drug in combination with capecitabine. (time frame: Duration of study). The study lists 3 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 6 Oct 2020.