Metastatic CancerPhase 1NCT01316822
A Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers
A Phase 1 study testing ARRY-382, cFMS inhibitor; oral in people with Metastatic Cancer, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 2 sites in United States.
Trial summary
This is a Phase 1 study during which patients with advanced cancer will receive investigational study drug ARRY-382. Patients will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- ARRY-382, cFMS inhibitor; oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Oct 2012
- 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
- A histologically or cytologically confirmed diagnosis of advanced or metastatic solid cancer refractory to standard treatment, for which no standard therapy is available or for which the patient refuses standard therapy.
- Measurable disease or evaluable, nonmeasurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Hemoglobin ≥ 9.0 g/dL, ANC > 1500/uL and platelet count ≥ 100,000/uL.
- AST/serum glutamic oxaloacetic transaminase (SGOT) and ALT/serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 × the upper limit of normal (ULN).
- Bilirubin ≤ ULN.
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- Serum creatinine ≤ 1.5 × ULN.
- Potassium, magnesium and calcium (corrected calcium when serum albumin levels are abnormal) within the normal range.
- Additional criteria exist.
Who cannot join
- 12-lead ECG demonstrating a mean QTcF > 450 msec (triplicate assessment) at the Screening Visit or history/evidence of long QT syndrome.
- History of acute coronary syndromes, including unstable angina, coronary angioplasty, or stenting, within the past 24 weeks.
- Use of concomitant medications that prolong the QT/QTc interval, as assessed by the Investigator, within 14 days prior to first dose of study drug.
- Use of concomitant medication that is a strong CYP3A inhibitor or inducer within 14 days prior to first dose of study drug.
- Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- 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).
- Active refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease) or significant bowel resection that, in the judgment of the Investigator, would preclude adequate absorption (a previous Whipple procedure is allowed).
- Additional criteria exist.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229
About this study
This is a Phase 1 study during which patients with advanced cancer will receive investigational study drug ARRY-382. Patients will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 50 patients from the US will be enrolled in this study.
- Conditions
- Metastatic Cancer
- Being tested
- ARRY-382, cFMS inhibitor; oral
- Keywords
- CSF1R, M-CSF, CSF-1, c-FMS, Tumor-associated macrophage, Macrophage-Colony Stimulating Factor-1, Receptor tyrosine kinase inhibitor, Tumor cell-induced osteolysis
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARRY-382, cFMS inhibitor; oralDrug
multiple dose, escalating
| Study group | Role | What they receive |
|---|---|---|
| ARRY-382 | Experimental | Not described Receives: Drug: ARRY-382, cFMS 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 as determined by adverse events, clinical laboratory tests and electrocardiograms.
Measured: Safety will be characterized for the duration of time that each patient stays on study; estimated one year.
Establish the maximum tolerated dose (MTD) of study drug.
Measured: The MTD will be based on Cycle 1 (28 days).
Characterize the plasma pharmacokinetics (PK) of study drug and its metabolites.
Measured: Safety will be characterized for the duration of time that each patient stays on study; estimated one year.
Secondary outcomes (1)
Assess the efficacy of study drug in terms of incidence of response rate and duration of response.
Measured: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met; estimated one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 26 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
- NCT01316822
- Sponsor's protocol ID
- ARRAY-382-101
- Status last verified
- Sep 2020
- First submitted
- 1 Dec 2010
- Last updated
- 21 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers
- ClinicalTrials.gov ID
- NCT01316822
- Acronym / sponsor ID
- ARRAY-382-101
- Conditions
- Metastatic Cancer
- Keywords
- CSF1R, M-CSF, CSF-1, c-FMS, Tumor-associated macrophage, Macrophage-Colony Stimulating Factor-1, Receptor tyrosine kinase inhibitor, Tumor cell-induced osteolysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Mar 2011 (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 cancer will receive investigational study drug ARRY-382. Patients will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 50 patients from the US 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-382 | Experimental | Drug: ARRY-382, cFMS inhibitor; oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A histologically or cytologically confirmed diagnosis of advanced or metastatic solid cancer refractory to standard treatment, for which no standard therapy is available or for which the patient refuses standard therapy.
- Measurable disease or evaluable, nonmeasurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Hemoglobin ≥ 9.0 g/dL, ANC > 1500/uL and platelet count ≥ 100,000/uL.
- AST/serum glutamic oxaloacetic transaminase (SGOT) and ALT/serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 × the upper limit of normal (ULN).
Key exclusion criteria (8 listed)
- 12-lead ECG demonstrating a mean QTcF > 450 msec (triplicate assessment) at the Screening Visit or history/evidence of long QT syndrome.
- History of acute coronary syndromes, including unstable angina, coronary angioplasty, or stenting, within the past 24 weeks.
- Use of concomitant medications that prolong the QT/QTc interval, as assessed by the Investigator, within 14 days prior to first dose of study drug.
- Use of concomitant medication that is a strong CYP3A inhibitor or inducer within 14 days prior to first dose of study drug.
- Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
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-382, cFMS inhibitor; oralmultiple dose, escalating | Drug | ARRY-382 |
Primary outcome
Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests and electrocardiograms.
Time frame: Safety will be characterized for the duration of time that each patient stays on study; estimated one year.
Establish the maximum tolerated dose (MTD) of study drug.
Time frame: The MTD will be based on Cycle 1 (28 days).
Characterize the plasma pharmacokinetics (PK) of study drug and its metabolites.
Time frame: Safety will be characterized for the duration of time that each patient stays on study; estimated one year.
1 secondary outcome
Assess the efficacy of study drug in terms of incidence of response rate and duration of response.
Time frame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met; estimated 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 21 Sep 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARRY-382, cFMS inhibitor; oral in people with Metastatic Cancer, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 2 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 9 inclusion and 8 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 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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 as determined by adverse events, clinical laboratory tests and electrocardiograms. (time frame: Safety will be characterized for the duration of time that each patient stays on study; estimated one year.). 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 21 Sep 2020.