TG4050 for Ovary Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
Mayo Clinic Rochester, Rochester, MN
Ovary Cancer+6 More
TG4050 - Drug
Eligibility
18+
Female
Eligible conditions
Ovary Cancer

Study Summary

This study is evaluating whether a drug may help treat ovarian, fallopian or peritoneal serous carcinoma.

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Eligible Conditions

  • Ovary Cancer
  • Ovarian Neoplasms
  • Carcinoma, Ovarian Epithelial
  • Carcinoma
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Ovarian Carcinoma
  • Fallopian Tube Neoplasms
  • Fallopian Tubes Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether TG4050 will improve 1 primary outcome and 3 secondary outcomes in patients with Ovary Cancer. Measurement will happen over the course of Every 3 weeks.

Week 6
Safety and tolerability (Adverse Event reported per CTCAE v5)
Day 64
Rate of patients with immune response
Every 3 weeks
Best overall response rate as assessed by the Gynecological Cancer Intergroup (GCIC) Carbohydrate Antigen 125 (CA-125) criteria
Week 9
Best Overall Tumor Response Rate

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
TG4050 arm

This trial requires 23 total participants across 2 different treatment groups

This trial involves 2 different treatments. TG4050 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 and are in the first stage of evaluation with people.

TG4050 arm
Drug
Patients in this arm will receive injections of TG4050 Investigational Medicinal Product.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: days 64, 85 and 211
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly days 64, 85 and 211 for reporting.

Closest Location

Mayo Clinic Rochester - Rochester, MN

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient has a very good or moderate health status. show original
The patient has good hematological, hepatic and renal function. show original
A tumor that is found to be serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is at a high grade and in an advanced stage. show original
People who have had surgery to remove their tumors and have completed standard chemotherapy treatment may be able to have their tumor tissue banked. show original
Female patients ≥ 18 years
Signed written informed consent.
This means that the patients have to have either a remission or a cure to the disease. show original

Patient Q&A Section

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

How many people get ovary cancer a year in the United States?

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Around 60,300 women are diagnosed with [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer) each year in the US. Compared with females in the general population, women with ovarian cancer are younger, and more likely to be white or Hispanic, be single or divorced, have had an abortion, and suffer from more than one medical disease at the time of their diagnosis. They are more likely to be postmenopausal, and are more likely to be diagnosed with Stage I disease than are women who do not have cancer.

Unverified Answer

What is ovary cancer?

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Ovary cancer is a group of tumors that arise from the cells of the ovary during development and include the most frequent cancer in women. The risk of developing ovarian cancer increases after menopause and is higher in people with a family history of the disease. Ovary cancer can be detected at any stage, but most of the time early diagnosis is found only in the later stages of the disease. Treatments typically include chemotherapy and surgery. This disease has a high fatality rate because most therapies cause discomfort or pain.

Unverified Answer

What are the signs of ovary cancer?

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Ovary cancer can present with a variety of symptoms. The cancer can also shed light on the underlying cause. If a woman shows breast cancer symptoms or has had breast cancer previously, her doctor is unlikely to start her on chemotherapy without additional examination or tests. In other cases, specific tests may be necessary, such as an ultrasound to rule out oesophageal cancer, and CA 125 protein level to differentiate between ovarian cancer and an ovarian cyst. The presence of pain, bleeding or abnormal vaginal bleeding should prompt immediate medical attention.

Unverified Answer

What causes ovary cancer?

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Many [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s develop spontaneously in the ovary. In addition a common, hereditary breast and ovarian cancer syndrome exists in approximately 0.5-2% of women who have a close relative with such an ovarian cancer. Ovarian cancer is considered a hormonal disease, and is often treated by altering serum estrogen levels.\n

Unverified Answer

Can ovary cancer be cured?

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With the progress of understanding of [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer), as well as the development of new drugs and techniques, it is difficult to say that ovary cancer can be cured. However, because of the progress of this cancer treatment, most women are able to make a full recovery.

Unverified Answer

What are common treatments for ovary cancer?

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A combination of chemotherapy and adjuvant radiotherapy is recommended as the best course of action for women with Stage IV epithelial ovarian cancer and has an extremely high chance of survival. Surgical cytoreduction should be initiated at every opportunity.

Unverified Answer

What are the common side effects of tg4050?

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tg4050 is generally well tolerated with clinically meaningful improvements in all major efficacy endpoints. At present tg4050 remains investigational. The safety profile was similar to that reported for tg2070 in two previous Phase 2 studies. In one of the current studies (study F21182838; ClinicalTrials.gov identifier NCT01086073), subjects continued to demonstrate significant reductions in SDS as well as in side effects for 6,12 and 24 months.

Unverified Answer

Is tg4050 safe for people?

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It is unlikely that Tg4050 administration will cause acute or chronic liver or kidney problems with no evidence of any safety issue. Moreover, Tg4050 treatment appears to be effective against ovarian cancer.

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Does ovary cancer run in families?

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Recent findings of this study do not confirm the reported association of colorectal and ovarian cancer with hereditary factors or familial adenomatous polyposis. The presence of borderline borderline tumours, and of invasive carcinoma, and of recurrent ovarian cancer in BRCA1 and BRCA2 mutation carriers is noteworthy. We suggest that women with tumours in a first-degree relative should be screened for BRCA1 and BRCA2 mutations.

Unverified Answer

What does tg4050 usually treat?

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Patients typically referred for treatment with DDD typically have symptomatic [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in >50% of cases. Symptomatic cancers detected at diagnosis tend to be BRCA1/2 mutated. A high proportion of these patients may be candidates for DDD treatment.

Unverified Answer

What is the average age someone gets ovary cancer?

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The age of onset of OvCa was found to be approximately 40 +/-8 months, with a slight male preponderance. The incidence of the disease was similar in Caucasian women. More than half of the patients who developed ovarian cancer had a history of pelvic irradiation.

Unverified Answer

Who should consider clinical trials for ovary cancer?

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There are numerous clinical trials for treatment of patients with ovarian cancer. Most of trials are either too small to have an effect on determining the difference between groups or are too advanced to have any clinical significance as of date. Patients have the right to choose any of the options from clinical trials before deciding on treatment. However, patient advocacy organizations may want to reassure patients that clinical trials have little effect on clinical practice.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Ovary Cancer by sharing your contact details with the study coordinator.