Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00003403
GPX-100 in Treating Patients With Solid Tumors
A Phase 1 study testing GPX-100 in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Gem Pharmaceuticals at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of GPX-100 in treating patients who have solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- GPX-100
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Aug 1999to 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
DISEASE CHARACTERISTICS: Incurable, solid tumors in patients who are not candidates for effective systemic therapy Progressive disease defined as a 25% increase in diameter of measurable lesions or appearance of new lesions
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Greater than 16 weeks Hematopoietic: WBC at least 4000/mm3 Platelet count at least 125,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin within normal limits SGOT no greater than 1.5 times normal (2.5 times normal with disease involvement) Alkaline phosphatase no greater than 2.5 times normal PT or PTT less than 1.5 times normal Renal: Creatinine no greater than 1.5 times normal Creatinine clearance at least 60 mL/min Cardiovascular: No history of congestive heart failure, active ischemic heart disease, or uncontrolled hypertension No myocardial infarction within the past 6 months Other: Not pregnant or nursing (negative pregnancy test required) Fertile patients must use effective contraception No weight loss of 10% or more in the past 3 months No frequent vomiting No severe anorexia
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered No greater than 300 mg/m2 cumulative dose of doxorubicin No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior hormone therapy No concurrent anticancer hormone therapy Concurrent corticosteroids allowed Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since prior investigational drug therapy No other concurrent investigational therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
About this study
Official title: Phase I Safety and Efficacy Study of an Intravenous Formulation of the Anthracycline Analog, GPX-100, in the Treatment of Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of GPX-100 in treating patients who have solid tumors.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of GPX-100 in outpatients with incurable, solid tumors who are not candidates for effective systemic therapy. II. Evaluate and quantify the toxicity of GPX-100 in this patient population. III. Identify any changes in disease status in this patient population.
OUTLINE: This is an open label, multicenter, dose escalation study. Patients receive GPX-100 IV once every 3 weeks. Patients receive 2 courses of treatment in the absence of disease progression or dose limiting toxicity. Treatment may continue for up to 6 courses (4 courses with prior doxorubicin) in patients with responding or non-progressing disease. One patient is entered at each of the first 3 dose levels. Cohorts of 3-6 patients are entered at subsequent dose levels. The maximum tolerated dose of GPX-100 is defined as the dose at which no more than 2 instances of dose limiting toxicity are observed in 6 patients.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
- Being tested
- GPX-100
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPX-100Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2004 (estimated)
- Study startAug 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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
Sponsor and investigators
- Lead sponsor
- Gem Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederick J. Dechow, PhD, Study chair, Gem Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003403
- Sponsor's protocol ID
- CDR0000066409
- Other IDs
- GEM-97-002, MAYO-IRB-153-98, NCI-V98-1441
- Status last verified
- Feb 2001
- First submitted
- 1 Nov 1999
- Last updated
- 23 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety and Efficacy Study of an Intravenous Formulation of the Anthracycline Analog, GPX-100, in the Treatment of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00003403
- Acronym / sponsor ID
- CDR0000066409
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Gem PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 1999
- First posted
- 24 May 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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of GPX-100 in treating patients who have solid tumors.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of GPX-100 in outpatients with incurable, solid tumors who are not candidates for effective systemic therapy. II. Evaluate and quantify the toxicity of GPX-100 in this patient population. III. Identify any changes in disease status in this patient population.
OUTLINE: This is an open label, multicenter, dose escalation study. Patients receive GPX-100 IV once every 3 weeks. Patients receive 2 courses of treatment in the absence of disease progression or dose limiting toxicity. Treatment may continue for up to 6 courses (4 courses with prior doxorubicin) in patients with responding or non-progressing disease. One patient is entered at each of the first 3 dose levels. Cohorts of 3-6 patients are entered at subsequent dose levels. The maximum tolerated dose of GPX-100 is defined as the dose at which no more than 2 instances of dose limiting toxicity are observed in 6 patients.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| GPX-100 | Drug | – |
Primary outcome
Not reported in the source record.
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 23 Apr 2013.
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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.
Frederick J. Dechow, PhD study chair
Gem Pharmaceuticals
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 GPX-100 in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Gem Pharmaceuticals 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?
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 23 Apr 2013. 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.
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 23 Apr 2013; AzTrials last refreshed its copy on 29 Oct 2026.