Solid MalignanciesPhase 1NCT00090727
Chemotherapy for Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
A Phase 1 study testing AQ4N in people with Solid Malignancies and Non-Hodgkin's Lymphoma, run by Novacea at 2 sites in United States.
Trial summary
The purposes of this study are to determine: the largest dose of AQ4N that can be safely given once a week for three weeks out of a 4 week cycle the side effects of AQ4N when given on the above schedule how much AQ4N is in the blood and urine at specific times after administration and how the body get rids of AQ4N if… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Malignancies, Non-Hodgkin's Lymphoma
- What is being tested?
- AQ4N
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2004to not given
- 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
- Advanced solid malignancy or non-Hodgkin's lymphoma that is refractory to treatment or has recurred
- Age > 18 years
- Adequate hematologic (blood), kidney and liver function
- Negative pregnancy test (females of childbearing potential only)
- Willingness to use effective contraception by both males and females throughout the treatment period and for at least 2 months following treatment.
Who cannot join
- Any chemotherapy or radiation within the past 4 weeks
- Symptomatic or uncontrolled brain metastases (patients with history of brain metastases who have had repeat brain scans within the past 30 days that demonstrate no evidence of tumor progression or brain swelling and who do not require corticosteriod treatment may be eligible)
- Significant cardiovascular illness including, but not limited to, the following: active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, heart attack within the past six months, or uncontrolled, irregular heart beat
- Inadequate cardiac function
- Prior investigational therapy within the past 28 days
- Pregnant or breast feeding women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cancer Therapy & Research Center / Institute for Drug Development
San Antonio, Texas, 78229
Weiler Hospital of Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies
The purposes of this study are to determine:
- the largest dose of AQ4N that can be safely given once a week for three weeks out of a 4 week cycle
- the side effects of AQ4N when given on the above schedule
- how much AQ4N is in the blood and urine at specific times after administration and how the body get rids of AQ4N
- if AQ4N helps treat cancer
Read the detailed description
This study is for people who have advanced cancer for which standard chemotherapy did not work or for which there are no reliably, effective treatments.
AQ4N is an experimental chemotherapy that is thought to target tumor areas with low oxygen content and low blood supply; tumor areas that are usually the most resistant to standard chemotherapy and radiation treatment. AQ4N may be beneficial in cancer treatment by interfering with a protein that is required for cells to grow and divide, causing tumors to die or to delay their growth.
All patients in this study will receive AQ4N. The dose will be increased for each new patient or group of patients until the maximum tolerated dose is reached.
- Conditions
- Solid Malignancies, Non-Hodgkin's Lymphoma
- Being tested
- AQ4N
- Keywords
- diffuse, follicular, chronic lymphocytic leukemia, colorectal cancer, pancreatic cancer, acute myelogenous leukemia, head and neck cancer, breast cancer, prostate cancer, ovarian cancer, bladder cancer, hypoxia, refractory, metastatic
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Colorectal Neoplasms, Pancreatic Neoplasms, Leukemia, Myeloid, Acute, Head and Neck Neoplasms, Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQ4NDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2004 (estimated)
- Study startAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid MalignanciesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Novacea
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090727
- Sponsor's protocol ID
- 021-001
- Status last verified
- Apr 2005
- First submitted
- 2 Sep 2004
- Last updated
- 2 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00090727
- Acronym / sponsor ID
- 021-001
- Conditions
- Solid Malignancies, Non-Hodgkin's Lymphoma
- Keywords
- diffuse, follicular, chronic lymphocytic leukemia, colorectal cancer, pancreatic cancer, acute myelogenous leukemia, head and neck cancer, breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants
- Lead sponsor
- NovaceaIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- First posted
- 6 Sep 2004 (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.
The purposes of this study are to determine:
- the largest dose of AQ4N that can be safely given once a week for three weeks out of a 4 week cycle
- the side effects of AQ4N when given on the above schedule
- how much AQ4N is in the blood and urine at specific times after administration and how the body get rids of AQ4N
- if AQ4N helps treat cancer
Detailed description
This study is for people who have advanced cancer for which standard chemotherapy did not work or for which there are no reliably, effective treatments.
AQ4N is an experimental chemotherapy that is thought to target tumor areas with low oxygen content and low blood supply; tumor areas that are usually the most resistant to standard chemotherapy and radiation treatment. AQ4N may be beneficial in cancer treatment by interfering with a protein that is required for cells to grow and divide, causing tumors to die or to delay their growth.
All patients in this study will receive AQ4N. The dose will be increased for each new patient or group of patients until the maximum tolerated dose is reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 (5 listed)
- Advanced solid malignancy or non-Hodgkin's lymphoma that is refractory to treatment or has recurred
- Age > 18 years
- Adequate hematologic (blood), kidney and liver function
- Negative pregnancy test (females of childbearing potential only)
- Willingness to use effective contraception by both males and females throughout the treatment period and for at least 2 months following treatment.
Key exclusion criteria (6 listed)
- Any chemotherapy or radiation within the past 4 weeks
- Symptomatic or uncontrolled brain metastases (patients with history of brain metastases who have had repeat brain scans within the past 30 days that demonstrate no evidence of tumor progression or brain swelling and who do not require corticosteriod treatment may be eligible)
- Significant cardiovascular illness including, but not limited to, the following: active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, heart attack within the past six months, or uncontrolled, irregular heart beat
- Inadequate cardiac function
- Prior investigational therapy within the past 28 days
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 |
|---|---|---|
| AQ4N | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2006.
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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.
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 AQ4N in people with Solid Malignancies and Non-Hodgkin's Lymphoma, run by Novacea 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 6 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: status not confirmed, as of the sponsor's last update on 2 Nov 2006. 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?
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.
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 2 Nov 2006.