LymphomaPhase 1NCT00471367
Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD4877
A Phase 1 study testing AZD4877 in people with Lymphoma and NHL, run by AstraZeneca at 3 sites in United States.
Trial summary
This study has two parts (A and B). The primary purpose of Part A is to find the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a twice a week basis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, NHL, Non-Hodgkin Lymphoma
- What is being tested?
- AZD4877
- Type of treatment
- Injection or infusion
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2007to Dec 2008
- 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
- Part A: Advanced solid tumors (including lymphoma without bone marrow involvement) for which standard treatment doesn't exist or is no longer effective.
- Part B: B-cell non-Hodgkin lymphoma that is not eligible for curative therapy or has relapsed.
- Relatively good overall health other than your cancer
Who cannot join
- Poor bone marrow function (not producing enough blood cells). Serious heart conditions. Poor liver or kidney function
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Greenville, South Carolina
Research Site
New York, New York
Research Site
Philadelphia, Pennsylvania
About this study
Official title: A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Twice a Week in Adult Patients With Advanced Solid Malignancies Including Lymphoma
This study has two parts (A and B). The primary purpose of Part A is to find the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a twice a week basis. For Part B, an additional 20 patients will be treated at the maximum dose identified in Part A. AZD4877 is an Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth
- Conditions
- Lymphoma, NHL, Non-Hodgkin Lymphoma
- Being tested
- AZD4877
- Keywords
- Phase I, AZD4877, Lymphoma, B-cell non-Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4877Drug
intravenous infusion administered twice a week for 2 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify a maximum tolerated dose of AZD4877 by assessment of the incidence of dose limiting toxicities
Measured: on a twice a week schedule for two weeks out of every three weeks
Secondary outcomes (2)
To evaluate the safety and tolerability of AZD4877 by assessment of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE) grade and type of AE, changes in laboratory values, vital signs, and incidence of protocol defined dose modification
Measured: assessed after each course of treatment
Dose Expansion (Part B):Estimate efficacy of AZD4877 through evaluation of objective response rate, progression-free survival and disease control rate in patients with B-cell non-Hodgkin lymphoma using the revised response criteria for malignant lymphoma
Measured: Assessed during treatment and post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2007 (estimated)
- Study startApr 2007
- Study completionDec 2008
Why it stopped: Part B of the study was terminated early due to a lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeffrey Skolnik, MD, Study director, AstraZenecaLea Burke, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471367
- Sponsor's protocol ID
- D2782C00006
- Status last verified
- Sep 2009
- First submitted
- 7 May 2007
- Last updated
- 24 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Twice a Week in Adult Patients With Advanced Solid Malignancies Including Lymphoma
- ClinicalTrials.gov ID
- NCT00471367
- Acronym / sponsor ID
- D2782C00006
- Conditions
- Lymphoma, NHL, Non-Hodgkin Lymphoma
- Keywords
- Phase I, AZD4877, Lymphoma, B-cell non-Hodgkin lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Part B of the study was terminated early due to a lack of enrollment.
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Study completion
- Dec 2008 (actual)
- First posted
- 9 May 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 study has two parts (A and B). The primary purpose of Part A is to find the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a twice a week basis. For Part B, an additional 20 patients will be treated at the maximum dose identified in Part A. AZD4877 is an Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Part A: Advanced solid tumors (including lymphoma without bone marrow involvement) for which standard treatment doesn't exist or is no longer effective.
- Part B: B-cell non-Hodgkin lymphoma that is not eligible for curative therapy or has relapsed.
- Relatively good overall health other than your cancer
Key exclusion criteria (1 listed)
- Poor bone marrow function (not producing enough blood cells). Serious heart conditions. Poor liver or kidney function
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 |
|---|---|---|
| AZD4877intravenous infusion administered twice a week for 2 weeks | Drug | – |
Primary outcome
To identify a maximum tolerated dose of AZD4877 by assessment of the incidence of dose limiting toxicities
Time frame: on a twice a week schedule for two weeks out of every three weeks
2 secondary outcomes
To evaluate the safety and tolerability of AZD4877 by assessment of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE) grade and type of AE, changes in laboratory values, vital signs, and incidence of protocol defined dose modification
Time frame: assessed after each course of treatment
Dose Expansion (Part B):Estimate efficacy of AZD4877 through evaluation of objective response rate, progression-free survival and disease control rate in patients with B-cell non-Hodgkin lymphoma using the revised response criteria for malignant lymphoma
Time frame: Assessed during treatment and post treatment
Results and safety
The study was stopped early (reason given: Part B of the study was terminated early due to a lack of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2009.
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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.
Jeffrey Skolnik, MD study director
AstraZeneca
Lea Burke study chair
AstraZeneca
3 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 AZD4877 in people with Lymphoma and NHL, run by AstraZeneca at 3 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 24 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early (reason given: Part B of the study was terminated early due to a lack of enrollment.). Results are not available in the source record.
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?
To identify a maximum tolerated dose of AZD4877 by assessment of the incidence of dose limiting toxicities (time frame: on a twice a week schedule for two weeks out of every three weeks). 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 24 Sep 2009.