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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

  1. First posted3 May 2004 (estimated)
  2. Study startApr 1999

Resources

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)
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

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.

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