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Protein

Pharmacokinetic Study for Bladder Cancer

Phase 1
Waitlist Available
Led By Monish Aron, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study Summary

This trial is testing a new protein to treat bladder cancer in patients who have not responded to BCG treatment. The protein works by preventing tumor cells from multiplying and blocking the growth of blood vessels that bring nutrients to the tumor.

Eligible Conditions
  • Stage I Bladder Cancer
  • Bladder Cancer
  • Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Maximum tolerated dose (MTD) and recommended phase II dose (RP2D)

Side effects data

From 2023 Phase 2 trial • 2 Patients • NCT03477396
100%
Alanine aminotransferase increased
100%
Cough
100%
Neutrophil count decreased
100%
Fatigue
100%
Alkaline phosphatase increased
100%
Aspartate aminotransferase increased
100%
White blood cell decreased
100%
Hyponatremia
100%
Nausea
50%
Anxiety
50%
Alopecia
50%
Vomiting
50%
Gastroesophageal reflux disease
50%
Creatinine increased
50%
Cholesterol high
50%
Dry skin
50%
Dyspnea
50%
Lymphocyte count decreased
50%
Sore throat
50%
Hot flashes
50%
Epistaxis
50%
Rash acneiform
50%
left upper eyelid droop
50%
Anorexia
50%
Constipation
50%
Dyspepsia
50%
Chills
50%
Pain
50%
Edema limbs
50%
blood in stool
50%
Upper respiratory infection
50%
Platelet count decreased
50%
Hyperglycemia
50%
Hyperkalemia
50%
Hypertriglyceridemia
50%
Hypoalbuminemia
50%
Hypoglycemia
50%
Arthralgia
50%
Osteoporosis
50%
Headache
50%
Memory impairment
50%
Depression
50%
Anemia
50%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Ribociclib, Aromatase Inhibitor)

Trial Design

1Treatment groups
Experimental Treatment
Group I: sEphB4-HSAExperimental Treatment2 Interventions
Cohorts of at least 3 participants each will be treated with escalating doses of sEphB4-HAS at 25mg, 50 mg, 75mg, 100 mg, and 125 mg administered intravesically over 2 hours once a week for 6 consecutive weeks to determine the maximum tolerated dose (MTD) and recommended phase II dosing (RP2D). Cycle repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,288 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,272 Total Patients Enrolled
Monish Aron, MDPrincipal InvestigatorUniversity of Southern California

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still roles available for participants in this clinical experiment?

"According to the clinicaltrials.gov database, this specific trial is not currently recruiting patients and has had no recent updates; however, there are 2718 other medical trials actively seeking participants presently."

Answered by AI

What other assessments of Pharmacokinetic Study have been done in the past?

"Currently, 7 studies have been established to assess the pharmacokinetic study. None of them are in Phase 3 yet. The majority of trails take place in Newport Beach, California; however, trials for this drug can be found at 28 different treatment sites."

Answered by AI

Is this medical trial open to individuals below the age of 25?

"This trial is open to patients from 18-80 years old. Meanwhile, there are 80 clinical trials for minors and 2696 for seniors."

Answered by AI

To what extent is enrollment in this trial open to the public?

"To qualify for this clinical study, participants must have a urinary bladder and fall between the ages of 18-80. Currently 36 patients are needed to complete the trial."

Answered by AI

Is this endeavor a pioneering effort?

"Presently, there are 7 active trials of Pharmacokinetic Study across 1 nation and 20 cities. Vasgene Therapeutics, Inc first initiated the trial in 2015 which included 61 patients; it has since been conducted twice more. The initial stage of drug approval (Phase 1) was successfully completed."

Answered by AI

Has the Pharmacokinetic Study been given regulatory approval by the FDA?

"A score of 1 was assigned to this pharmacokinetic study, as it is a Phase 1 trial and thus lacks substantial evidence for its safety or efficacy."

Answered by AI

What is the maximum capacity for enrollment in this trial?

"Sadly, this trial is no longer taking on new participants. It was first announced on December 1st 2022 and its details were last modified on August 5th 2022. However, if you're still looking to join a study, 2711 clinical trials for urinary bladder are actively enrolling patients as well as 7 Pharmacokinetic Studies that welcome volunteers."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
sEphB4-HSA in Treating Participants With BCG-Unresponsive or Refractory Bladder Cancer
2023. "sEphB4-HSA in Treating Participants With BCG-Unresponsive or Refractory Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03552796.
~0 spots leftby Aug 2024
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