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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.