TSR-042 for Endometrial Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Juravinski Cancer Centre, Hamilton, Canada
Endometrial Neoplasms+1 More
TSR-042 - Drug
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called niraparib can improve the outcome of patients with endometrial cancer.

See full description

Eligible Conditions

  • Endometrial Neoplasms
  • Endometrial Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Endometrial Neoplasms

Study Objectives

This trial is evaluating whether TSR-042 will improve 1 primary outcome and 5 secondary outcomes in patients with Endometrial Neoplasms. Measurement will happen over the course of 16 weeks.

16 weeks
Clinical benefit rate
5 years
Duration of response
Number of side effects
Overall response rate
Overall survival rate
Progression free survival rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Endometrial Neoplasms

Trial Design

1 Treatment Group

Niraparib +TSR-042
1 of 1
Experimental Treatment

This trial requires 51 total participants across 1 different treatment group

This trial involves a single treatment. TSR-042 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 2 and have already been tested with other people.

Niraparib +TSR-042200/300 mg Niraparib by mouth once a day for 21 days cycle. 500 mg of TSR-042 intravenously on the first day of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years for reporting.

Closest Location

Juravinski Cancer Centre - Hamilton, Canada

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Endometrial Neoplasms or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically confirmed epithelial endometrial cancer. All histological subtypes are allowed except for endometrial sarcoma, carcinosarcoma, clear cell, mixed and adenosquamous tumors.
Patients must have radiographic evidence of disease progression following the most recent line of treatment.
Patients must have previously received at least one line of platinum-based chemotherapy. Prior hormonal and immunotherapy are allowed. There is no restriction on the total number prior lines of therapy.
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥10 mm with CT scan, MRI, or calipers by clinical exam, and ≥15mm for nodal lesions. Areas of previous radiation may not serve as measurable disease unless there is evidence of progression post radiation.
Patients must have archival tumor sample available for PTEN analysis. If archival tissue is not available, the patient will have the option to undergo tumor biopsy.
Eastern Cooperative Group (ECOG) performance status ≤ 2.
Life expectancy of greater than 12 weeks.
Within 7 days of the proposed start of treatment, patients must have normal organ and marrow function.
Participant receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to initiating protocol therapy
Patient must agree to not donate blood during the study or for 90 days after the last dose of study treatment

Patient Q&A Section

How many people get endometrial neoplasms a year in the United States?

"The incidence of endometrial cancer in the United States is at its highest level in the last four decades. A major decrease can be expected in the future." - Anonymous Online Contributor

Unverified Answer

Can endometrial neoplasms be cured?

"The majority of stage II disease can be cured without apparent risk during follow-up. The overall cure rate remains low, but the percentage of women with stage III/IV disease who do not relapse during follow-up is considerable." - Anonymous Online Contributor

Unverified Answer

What are the signs of endometrial neoplasms?

"Endometrial cancer may present with abdominal pain, vaginal bleeding, genital mass or discharge. Lymphadenopathy may be present as a result of spread to the lymph nodes. There is a wide range of presentation of endometrial cancer, and these signs are nonspecific. There may be a wide range of diagnoses which include ovarian cancer, endometrial stroma sarcoma and endometriosis associated adenocarcinoma." - Anonymous Online Contributor

Unverified Answer

What are common treatments for endometrial neoplasms?

"In terms of common treatments for endometrial neoplasms, hysterectomy, and radiation are effective options. The treatment of endometrial neoplasms should focus on removal of the primary tumour." - Anonymous Online Contributor

Unverified Answer

What causes endometrial neoplasms?

"Endometrial carcinoma accounts for 65% of all endometrial neoplasms in our population. The data provide new insights into this enigmatic disease. The most common presenting symptom was anemia. The etiology for endometrial neoplasia may arise in early pregnancy or be a result of local immunologic damage after delivery. To evaluate the potential role for specific vaccination programs, our data should be considered in combination with the data from other countries." - Anonymous Online Contributor

Unverified Answer

What is endometrial neoplasms?

"Endometrial cancer is one of the most common forms of cancer in the United States and causes many deaths annually, with approximately 500,000 cases and 20,000 deaths in 2006. Endometrial cancer is usually detected by screening. The cause of most cases is unknown. It is not known which factor causes the cancer to form. But if it occurs as the result of a cancer in another part of the body, the patient must be screened for that as well. When a doctor says your test results show endometrial neoplasia, the next thought is that an endometrial biopsy is needed to determine the cause. endometrial cancer screening in women of reproductive age who have a family history of endometrial cancer." - Anonymous Online Contributor

Unverified Answer

How serious can endometrial neoplasms be?

"Although endometrial neoplasm could be fatal if untreated, almost 80% of patients undergoing surgery for this disease will survive without chemotherapy. However, patients should be aware that the disease can be recurrent. Thus, for women who have a history of endometrial lesions, they should be monitored more closely." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating endometrial neoplasms?

"The endometrial cancer treatment is quite complicated and there is still a long way to go to figuring out effective treatment and adjuvant therapies. However, several novel approaches are getting popular and hopeful regarding endometrial cancer. Therefore, there is an update concerning what is new, but only potential treatments are shown within this article." - Anonymous Online Contributor

Unverified Answer

Has tsr-042 proven to be more effective than a placebo?

"TS-042 treatment exhibited significantly greater PFS (p < 0.001) and OS (p < 0.01) than control treatment. Results from a recent paper of this small clinical trial of TS-042 indicate that TS-042 is effective and well tolerated with potential clinical implications." - Anonymous Online Contributor

Unverified Answer

Does endometrial neoplasms run in families?

"Endometrial neoplasms run in families probably because of linkage of genetic defects to telomerase activation. The same association is described in primary endometrial carcinoma. However, our data did not confirm a common ancestor for endometrial and other mucinous neoplasms in the same family members." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets endometrial neoplasms?

"A diagnosis of endometrial neoplasms has become more frequent because of the increase in use of estrogen-progestin combined oral contraceptives, and the elderly women who are taking these drugs have a higher risk of endometrial neoplasms. There is a need for more awareness of the existence of endometrial neoplasms among the public and for the development of a screening test for endometrial neoplasms." - Anonymous Online Contributor

Unverified Answer

Is tsr-042 safe for people?

"In a recent study, findings shows that the pharmacology of TSR-042 is similar to that of the lead compound, the first-in-class anti-cancer agent BAY 1137098. The side effects observed are consistent with those seen with this agent and other targeted inhibitor agents currently in development and clinical studies. As this drug is being developed for the treatment of endometrial cancer we intend to begin a dose-finding trial of TS-042 in patients with recurrent, well-differentiated endometrial cancer." - 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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