Advanced Solid TumorsPhase 1NCT00462358
A Study of ARRY-520 in Patients With Advanced Cancer
A Phase 1 study testing ARRY-520, KSP(Eg5) inhibitor; intravenous and Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous in people with Advanced Solid Tumors, 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 solid tumors will receive investigational study drug ARRY-520. This study has two parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- ARRY-520, KSP(Eg5) inhibitor; intravenous and Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2007to Nov 2010
- 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 malignancy.
- Advanced solid tumors that have recurred or progressed following standard therapy(ies).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Adequate hematology counts and serum chemistry values.
- Additional criteria exist.
Who cannot join
- Treatment with an investigational product or device, or anti-neoplastic therapy (with the exclusion of hormone therapy where the therapy will continue at a standard dose throughout the study) within 28 days prior to the first dose of study drug.
- Major surgery within 28 days prior to the first dose of study drug.
- Radiotherapy (RT) within 28 days prior to the first dose of study drug (except if local RT to <5% of the bone marrow).
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis C, and/or active hepatitis B.
- Additional criteria exist.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, 21201
Wayne State University, Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-520.
This study has two parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 15 patients (per schedule) from the US will be enrolled in Part 1 (Completed).
In the second part of the study, patients will receive the best dose of study drug determined from the first part of the study and will be followed to evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 15 patients from the US will be enrolled in Part 2 (Completed).
- Conditions
- Advanced Solid Tumors
- Being tested
- ARRY-520, KSP(Eg5) inhibitor; intravenous, Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARRY-520, KSP(Eg5) inhibitor; intravenousDrug
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneousDrug
Part 1: standard of care; Part 2: standard of care.
| Study group | Role | What they receive |
|---|---|---|
| ARRY-520 | Experimental | Not described Receives: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous |
| ARRY-520 + G-CSF support | Experimental | Not described Receives: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous; Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous |
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, with and without G-CSF.
Measured: Part 1
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Measured: Part 1 and Part 2
Secondary outcomes (2)
Characterize the pharmacokinetics of the study drug.
Measured: Part 1 and Part 2
Assess the efficacy of the study drug in terms of tumor response.
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 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT00462358
- Sponsor's protocol ID
- ARRAY-520-101
- Status last verified
- Sep 2020
- First submitted
- 18 Apr 2007
- Last updated
- 28 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ARRY-520 in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00462358
- Acronym / sponsor ID
- ARRAY-520-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2007 (actual)
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Apr 2007 (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-520.
This study has two parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 15 patients (per schedule) from the US will be enrolled in Part 1 (Completed).
In the second part of the study, patients will receive the best dose of study drug determined from the first part of the study and will be followed to evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 15 patients from the US will be enrolled in Part 2 (Completed).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARRY-520 | Experimental | Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous |
| ARRY-520 + G-CSF support | Experimental | Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous, Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological or cytological evidence of malignancy.
- Advanced solid tumors that have recurred or progressed following standard therapy(ies).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Adequate hematology counts and serum chemistry values.
- Additional criteria exist.
Key exclusion criteria (5 listed)
- Treatment with an investigational product or device, or anti-neoplastic therapy (with the exclusion of hormone therapy where the therapy will continue at a standard dose throughout the study) within 28 days prior to the first dose of study drug.
- Major surgery within 28 days prior to the first dose of study drug.
- Radiotherapy (RT) within 28 days prior to the first dose of study drug (except if local RT to <5% of the bone marrow).
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis C, and/or active hepatitis B.
- Additional criteria exist.
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-520, KSP(Eg5) inhibitor; intravenousPart 1: multiple dose, escalating; Part 2: multiple dose, single schedule. | Drug | ARRY-520, ARRY-520 + G-CSF support |
| Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneousPart 1: standard of care; Part 2: standard of care. | Drug | ARRY-520 + G-CSF support |
Primary outcome
Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.
Time frame: Part 1
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: Part 1 and Part 2
2 secondary outcomes
Characterize the pharmacokinetics of the study drug.
Time frame: Part 1 and Part 2
Assess the efficacy of the study drug in terms of tumor response.
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 28 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-520, KSP(Eg5) inhibitor; intravenous and Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous in people with Advanced Solid Tumors, 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 5 inclusion and 5 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 28 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?
Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF. (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 28 Sep 2020.