Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00004049
SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing apomine in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Genzyme, a Sanofi Company at 1 site 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 SR-45023A in treating patients who have locally advanced or metastatic solid tumors that have not responded to previous treatment. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- apomine
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or metastatic solid tumors refractory to standard therapy or for which no standard therapy exists (surgery, radiotherapy, and/or chemotherapy) Measurable or evaluable disease by medical photograph, plain x-ray, CT, MRI, palpation, or serum tumor markers at least 2 times upper limit of normal No symptomatic, progressive brain metastases by CT or MRI scan No cerebral edema No leukemia or multiple myeloma
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL No coagulation disorders Hepatic: Bilirubin normal AST and ALT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver involvement) PT or INR, and PTT normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No cardiac conduction abnormalities Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active or uncontrolled infection No other concurrent severe disease No known hypersensitivity to SR-45023A analogs No concurrent or recent (within past 6 months) small bowel obstruction, symptoms of small bowel obstruction, or any other gastrointestinal disease impacting absorption of study drug No psychiatric disorders or geographic distance that would prevent compliance
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks since carboplatin, mitomycin, or nitrosoureas) and recovered No prior SR-45023A No other concurrent chemotherapy Endocrine therapy: No concurrent steroid therapy for brain disease No concurrent hormonal cancer therapy (except contraception, hormone replacement therapy, or corticosteroids) Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy (except symptomatic radiotherapy for pathologic fractures) Surgery: At least 4 weeks since prior surgery and recovered Other: At least 4 weeks since prior investigational agents No other concurrent investigational agents No concurrent anticoagulation therapy (e.g., heparin) except low dose warfarin for central venous catheter patency No concurrent digoxin, beta blockers, or calcium channel blockers No concurrent H2 histamine inhibitors (e.g., ranitidine, famotidine, or cimetidine), proton pump inhibitors (e.g., omeprazole or lansoprazole), or other drugs that might interfere with study drug absorption
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Drug Development
San Antonio, Texas, 78245-3217
About this study
Official title: A Phase I and Pharmacokinetic Study of SR-45023A Administered Once Every 7 Days
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 SR-45023A in treating patients who have locally advanced or metastatic solid tumors that have not responded to previous treatment.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of SR-45023A in patients with locally advanced or metastatic solid tumors. II. Determine the quantitative and qualitative toxic effects of SR-45023A in these patients. III. Assess the plasma and urine pharmacokinetics of SR-45023A and relate these to drug effects, if possible, in these patients. IV. Determine any preliminary antitumor activity of SR-45023A in these patients.
OUTLINE: This is a dose escalation study. Patients receive oral SR-45023A weekly. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SR-45023A until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for up to 1 month.
PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
- Being tested
- apomine
- 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.
apomineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2004 (estimated)
- Study startApr 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
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004049
- Sponsor's protocol ID
- CDR0000067233
- Other IDs
- ILEX-SR102-A4, SACI-IDD-99-06, NCI-V99-1560
- Status last verified
- May 2001
- First submitted
- 10 Dec 1999
- Last updated
- 29 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I and Pharmacokinetic Study of SR-45023A Administered Once Every 7 Days
- ClinicalTrials.gov ID
- NCT00004049
- Acronym / sponsor ID
- CDR0000067233
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- First posted
- 3 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 SR-45023A in treating patients who have locally advanced or metastatic solid tumors that have not responded to previous treatment.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of SR-45023A in patients with locally advanced or metastatic solid tumors. II. Determine the quantitative and qualitative toxic effects of SR-45023A in these patients. III. Assess the plasma and urine pharmacokinetics of SR-45023A and relate these to drug effects, if possible, in these patients. IV. Determine any preliminary antitumor activity of SR-45023A in these patients.
OUTLINE: This is a dose escalation study. Patients receive oral SR-45023A weekly. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SR-45023A until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for up to 1 month.
PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| apomine | 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 29 Aug 2018.
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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 study testing apomine in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Genzyme, a Sanofi Company 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?
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 29 Aug 2018. 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 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 29 Aug 2018.