Selinexor for Metastatic Ureter Urothelial Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California Davis Comprehensive Cancer Center, Sacramento, CA
Metastatic Ureter Urothelial Carcinoma+5 More
Selinexor - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating the best dose of selinexor and its effect with pembrolizumab in treating patients with urothelial carcinoma that are not eligible to receive the chemotherapy drug cisplatin, or have been given cisplatin and the cancer has gotten worse. Patients

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Eligible Conditions

  • Metastatic Ureter Urothelial Carcinoma
  • Locally Advanced Urothelial Carcinoma
  • Advanced Urothelial Carcinoma
  • Refractory Urothelial Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Selinexor will improve 2 primary outcomes and 2 secondary outcomes in patients with Metastatic Ureter Urothelial Carcinoma. Measurement will happen over the course of Up to 2 cycles (each cycle is 21 days).

Year 2
Progression-free survival (PFS)
Day 21
Recommended phase 2 dose (RP2D) (Phase Ib)
Up to 2 years
Incidence of grade 3 or higher AEs
Objective response rate (ORR) (Phase II)

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

Treatment (selinexor, pembrolizumab)
1 of 1
Experimental Treatment

This trial requires 12 total participants across 1 different treatment group

This trial involves a single treatment. Selinexor is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Treatment (selinexor, pembrolizumab)Patients receive selinexor PO on days 1, 8 and 15, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Selinexor
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

University of California Davis Comprehensive Cancer Center - Sacramento, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The text is about a measurable disease that is classified using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. show original
The individual is not eligible to receive cisplatin-based chemotherapy because they have renal dysfunction (defined as creatinine clearance [CrCl] =< 60 mL/min), > grade 2 peripheral neuropathy, or ototoxicity (defined as >= grade 2 hearing loss); OR the individual is unwilling to receive cisplatin; OR the individual has progressed on one platinum-based chemotherapy regimen for advanced disease. show original
The person has a hemoglobin level of 9 grams or more per deciliter show original
is a cutoff value used to define sepsis A cutoff value of 1.5 × 10^9/L is used to define sepsis for an absolute neutrophil count (ANC). show original
A platelet count of 100×10^9/L or higher is considered normal. show original
Pathologically confirmed locally advanced or metastatic urothelial carcinoma by histology
May have had neoadjuvant or adjuvant platinum-based chemotherapy or intravesical therapy in the past
>= 18 years of age
A person's Eastern Cooperative Oncology Group (ECOG) performance status score indicates how active they are in their cancer treatment show original
The patient has a life expectancy of three months or more. show original

Patient Q&A Section

Can carcinoma be cured?

"In contrast to the results of the review, we observed the occurrence of disease recurrence and death after treatment of carcinoma. The prognosis is strongly influenced by patients' age and sex." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating carcinoma?

"While conventional cancer therapies may have caused severe side effects and low satisfaction rating for patients, many recently developed treatments are expected to improve treatment survival rates and minimize side effects. To further our understanding of the development of novel drugs and therapies for the future, it will be of utmost need to search for prospective treatments in the next generation of medicines." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma a year in the United States?

"If cancers are screened through the general population, and carcinoma is detected at a relatively early stage, there will be significant progress in eliminating the disparity." - Anonymous Online Contributor

Unverified Answer

What is carcinoma?

"Carcinoma is malignant neoplasm. The malignant neoplasms can be subdivided according to cancer location and type, but the most obvious distinction is between benign and malignant neoplasms." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma?

"In the UK the signs of carcinoma are similar to those of other cancers, such as stomach cancer, kidney cancer, skin cancer or colorectal cancer. All of these forms of cancer may show many similar signs and symptoms. The only exception is lung cancer. In this cancer, symptoms are often non-specific, such as vague malaise and shortness of breath. Patients should often seek their doctor for a medical examination to assess their health properly, especially after a long latency period where some symptoms have been overlooked or misdiagnosed." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma?

"There is little evidence that chemical, genetic, infectious or environmental factors were causal for the development of sporadic cancers. Other factors such as genetic, environmental and lifestyle effects were more likely to play key roles in the causation of certain tumours. Thus, the primary focus of carcinogenesis research should be on these factors." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma?

"A wide range of treatments for carcinoma are used. Most patients prefer active active control of the disease with new antiproliferative agents. Localised radiation is often used on a temporary basis and often is applied in conjunction with antiproliferative drugs. More aggressive and enduring agents including targeted agents are now being explored more broadly. Overall, for carcinoma, we may look to a new generation of drugs." - Anonymous Online Contributor

Unverified Answer

What does selinexor usually treat?

"A handful of treatment-related adverse events were recorded including fatigue, nausea, abdominal pain, and headache. Most of these events were transient and did not result in discontinuation of selinexor treatment. At the dose of 10 mg in an intermittent schedule, selinexor does not usually cause adverse events but does result in low drug levels." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma?

"The most important prognostic factor for survival for patients with carcinoma of the lung was the depth of invasion. Advanced carcinomas that are invasive into the thoracic wall will have a worse outcome than those that have invaded only to or through the pulmonary fascia. Although survival differences were seen, none could be attributed to the depth of invasion." - Anonymous Online Contributor

Unverified Answer

Does selinexor improve quality of life for those with carcinoma?

"Findings from a recent study failed to demonstrate a clinically meaningful statistically significant improvement in quality of life in the selinexor arm compared with placebo, despite a more objective estimation of QOL in some QOL domains." - Anonymous Online Contributor

Unverified Answer

How serious can carcinoma be?

"Patients have good expectations and willingness to pay for treatment and follow-up of carcinoma after surgery, but some believe they need no treatment at all." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets carcinoma?

"There is no absolute age that everyone dies of carcinoma, and we might expect a small number of younger people dying of carcinoma than older persons." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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