Esophageal NeoplasmsPhase 1/2NCT00057395
A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Solid Malignancies
A Phase 1/2 study testing Aroplatin (Liposomal NDDP, L-NDDP) in people with Esophageal Neoplasms and Hepatocellular Carcinoma, run by Aronex Pharmaceuticals at 1 site in United States.
Trial summary
To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms, Hepatocellular Carcinoma, Colorectal Neoplasms
- What is being tested?
- Aroplatin (Liposomal NDDP, L-NDDP)
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 malignancies;
- Amenable to therapy with DACH platinum agents;
- Measurable disease (RECIST criteria);
- ECOG performance score of 0-2;
- Adequate hematopoietic, liver and renal function;
- Adequate cardiac function (maximum of class II, NYHA);
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- Women of childbearing potential must have a negative urine or serum pregnancy test;
- Signed written informed consent;
- Subjects must be willing to be followed during the course of treatment/observation and follow-up.
Who cannot join
- No other active malignancies;
- No prior therapy with oxaliplatin;
- No known brain metastases;
- Active, uncontrolled infection or other serious medical illnesses;
- Not using or have used any investigational therapy during four weeks before start of protocol treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
John Wayne Cancer Institute
Santa Monica, California, 90404
About this study
Official title: A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies
To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.
Read the detailed description
Primary Objective:
- Determine response rate (RR; complete and partial response [CR, PR]) and duration after therapy with Aroplatin™ in patients with advanced solid malignancies.
Secondary Objective:
- Determine the safety and tolerability of Aroplatin
- Conditions
- Esophageal Neoplasms, Hepatocellular Carcinoma, Colorectal Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Neoplasms
- Being tested
- Aroplatin (Liposomal NDDP, L-NDDP)
- Keywords
- Esophageal Neoplasms, Esophagus Neoplasm, Esophagus Cancer, Esophageal Cancer, Esophageal Tumors, Esophagus Tumors, Neoplasms, Esophageal, Hepatocellular Carcinoma, Carcinoma, Hepatocellular, Hepatoma, Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumor, Neoplasms, Colorectal, Ovarian Neoplasms, Ovary Neoplasms, Ovary Cancer, Ovary Carcinoma, Ovarian Cancer
- Medical subject headings
- Esophageal Neoplasms, Carcinoma, Hepatocellular, Colorectal Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aroplatin (Liposomal NDDP, L-NDDP)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Aronex Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057395
- Sponsor's protocol ID
- C-726-04
- Status last verified
- Apr 2004
- First submitted
- 1 Apr 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00057395
- Acronym / sponsor ID
- C-726-04
- Conditions
- Esophageal Neoplasms, Hepatocellular Carcinoma, Colorectal Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Neoplasms
- Keywords
- Esophageal Neoplasms, Esophagus Neoplasm, Esophagus Cancer, Esophageal Cancer, Esophageal Tumors, Esophagus Tumors, Neoplasms, Esophageal, Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Aronex PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 2 Apr 2003 (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.
To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.
Detailed description
Primary Objective:
- Determine response rate (RR; complete and partial response [CR, PR]) and duration after therapy with Aroplatin™ in patients with advanced solid malignancies.
Secondary Objective:
- Determine the safety and tolerability of Aroplatin
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 (9 listed)
- Advanced solid malignancies;
- Amenable to therapy with DACH platinum agents;
- Measurable disease (RECIST criteria);
- ECOG performance score of 0-2;
- Adequate hematopoietic, liver and renal function;
Key exclusion criteria (5 listed)
- No other active malignancies;
- No prior therapy with oxaliplatin;
- No known brain metastases;
- Active, uncontrolled infection or other serious medical illnesses;
- Not using or have used any investigational therapy during four weeks before start of protocol treatment.
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 |
|---|---|---|
| Aroplatin (Liposomal NDDP, L-NDDP) | 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 24 Jun 2005.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aroplatin (Liposomal NDDP, L-NDDP) in people with Esophageal Neoplasms and Hepatocellular Carcinoma, run by Aronex Pharmaceuticals at 1 site 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 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 Jun 2005.