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Hormone Refractory Prostate CancerPhase 1/2NCT00987753

Study Evaluating the Safety and Tolerability of L-377202

A Phase 1/2 study testing L-377202 in people with Hormone Refractory Prostate Cancer and Prostate Cancer, run by University of Alabama at Birmingham 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

The primary purpose of this study is to (1) determine the maximally tolerated dose (MTD) of L-377202 administered once every 3 weeks, (2) evaluate the safety and tolerability of L-377202 including the dose-limiting adverse effects of treatment with L-377202, and (3) assess the pharmacokinetics of various doses of… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
L-377202
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
Mar 1999to Nov 2001
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is at least an 18-year-old male and has histologically documented, progressive carcinoma of the prostate which is refractory to hormonal manipulation. Progressive disease may be documented by new lesions on bone scan, increase in radiologically measurable disease, or an increase in PSA (at least 50% increase from nadir confirmed twice and measured at least 2 weeks apart.)
  • An appropriate interval of time has passed since alteration of any hormonal therapy (e.g., 4 weeks for steroids, LHRH agonists, flutamide or megestrol acetate and 6 weeks for nilutamide and bicalutamide).
  • Patient has a serum PSA of 20 ng/mL or higher.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Patients has a life expectancy of >3 months.
  • Patient understands and agrees to participate in the study by providing written informed consent.

Who cannot join

  • Patient is mentally or legally incapacitated at the time of the study or has a history (less than 5 years prior to entry) of drug or alcohol abuse or is currently a user (including "recreational use") of any illicit drugs.
  • Patient has known HIV or a known HIV-related malignancy.
  • Patient has participated in another study (including FDA approved drugs for a non-FDA approved indication) of an investigational agent within the last 4 weeks.
  • Patient requires treatment or is anticipated to require treatment with Cyclosporine, Phenobarbital, phenytoin, or streptozocin.
  • Patient has received tumor directed immunologic therapy, radiation therapy, surgery, or chemotherapy within 4 weeks of the study. However, patients who are receiving thyroid replacement therapy may be included. For mitomycin or nitrosourea, there must be a 6-week treatment free interval.
  • Patient has received strontium treatment within 12 weeks prior to treatment.
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  • Patient is anticipated to require immunologic therapy, radiation therapy, surgery, or chemotherapy during the study.
  • Patient has received high-dose chemotherapy with stem cell rescue.
  • Patient has a history of significant cardiac dysrhythmias (Grade 3 or higher excluding atrial fibrillation).
  • Patient has recently had (within 6 months) a myocardial infarction, unstable angina, or congestive heart failure.
  • Patient has an abnormal PT (INR) or a PTT (>1.2 times normal). Low-dose warfarin (1 to 2 mg P.O. q.d.) or heparin (the equivalent of 5000 IU SQ b.i.d.) administered to maintain catheter patency is acceptable. Patients administered higher doses of anticoagulants may be considered on an individual basis pending discussion between the clinical monitor and investigator. Such patients will require more intensive monitoring of PT (INR) and aPTT (at least every other day).
  • Patient has an absolute neutrophil count <1500/mm3 or platelet count <100,000/mm3 or hemoglobin <9 gm/dL, bilirubin >1.5 times normal or ALT or AST >2.5 times normal or creatinine >1.5 times normal.
  • Patient has an active infection.
  • Patient has an active (edema, progressive disease, or clinical neurologic symptoms) metastatic CNS lesion.
  • Patient has received the equivalent of >180 mg/m2 of doxorubicin or >40 mg/m2 mitoxantrone.
  • Patient has left ventricular ejection fraction (LVEF) <45%.
  • Patient has received radiation to >25% of his total bone marrow.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: A PhaseI/II Study Evaluating the Safety, Tolerability, and Maximally Tolerated Dose of L-377202 Administered Once Every 3 Weeks

The primary purpose of this study is to (1) determine the maximally tolerated dose (MTD) of L-377202 administered once every 3 weeks, (2) evaluate the safety and tolerability of L-377202 including the dose-limiting adverse effects of treatment with L-377202, and (3) assess the pharmacokinetics of various doses of L-377202 and the plasma profile of liberated doxorubicin and leu-doxorubicin.

Read the detailed description

This is an open, nonrandomized, rising-dose study in patients with hormone refractory prostate cancer. Patients will be treated with L-377202 once every three weeks. Plasma concentrations of L-377202, liberated doxorubicin, and leu-doxorubicin will be obtained at defined time intervals throughout the study. At least 1 patient will be treated at each dose level until there is evidence of greater than or equal to Grade 2 drug-related toxicity. Each patient will be treated at only 1 dose level, although multiple cycles may be administered until signs of disease progression or unacceptable toxicity are evident. Doses will be doubled for each subsequent cohort of patients until evidence of greater than or equal to Grade 2 drug-related toxicity. Upon documentation of greater than or equal to Grade 2 drug-related toxicity, subsequent dose escalations will proceed along the modified Fibonacci scale and enroll at least 3 patients per dose level until 1 patient experiences dose-limiting toxicity (DLT).

Being tested
L-377202
Keywords
L-377202, prostate cancer, PSA
Medical subject headings
Prostatic Neoplasms, Salivary Gland Adenoma, Pleomorphic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L-377202Drug

    For each cycle, L-377202 will be administered as a 30-minute infusion every 3 weeks. The starting dose will be 20 mg/m2/week. Doses will be doubled until a patient experiences a greater than or equal to Grade 2 toxicity.

Study groups in NCT00987753
Study groupRoleWhat they receive
infusion of L-377202ExperimentalNot described
Receives: Drug: L-377202

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the administration of L-377202 every three weeks in patients with hormone refractory prostate cancer

    Measured: Every 3 weeks until disease progression or unacceptable toxicity

Secondary outcomes (1)

  1. Evaluation of the radiologic and/or PSA responses to L-377202 treatment

    Measured: Every 3 weeks until disease progression or unacceptable toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2009 (estimated)
  2. Study startMar 1999
  3. Primary completionSep 2000
  4. Study completionNov 2001

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00987753
Sponsor's protocol ID
F990224004
Other IDs
UAB 9902
Status last verified
May 2023
First submitted
30 Sep 2009
Last updated
25 May 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing L-377202 in people with Hormone Refractory Prostate Cancer and Prostate Cancer, run by University of Alabama at Birmingham 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 25 May 2023. 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?

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.

What does the primary outcome measure?

Evaluation of the administration of L-377202 every three weeks in patients with hormone refractory prostate cancer (time frame: Every 3 weeks until disease progression or unacceptable toxicity). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00987753.

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 25 May 2023.

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