This trial is evaluating whether CCI-001 will improve 6 primary outcomes and 2 secondary outcomes in patients with Cancer. Measurement will happen over the course of Cycle 1 (28 days).
This trial requires 70 total participants across 2 different treatment groups
This trial involves 2 different treatments. CCI-001 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.
many signs of cancer are associated with systemic disease such that they are rarely specific for a malignancy. As is almost always the case with clinical signs, it is difficult to decide from the findings which symptom, if any, reflects the presence of a particular condition.
Cancer may be cured. The key to a cure is detection and early intervention. If the early detection, and early intervention of cancer had occurred the cure would have been achieved decades ago. Early detection and early intervention is still necessary. The development of new detection approaches of cancer is essential. Current detection does not have good correlation with cure. For example CT scans and x-ray imaging can discover early bone metastases in breast cancer, but a cure has not been documented yet.
While the disease is named to describe it pathogenesis, it remains a disease characterized by the abnormal growth of cells that have the tendency to invade other cells.
Around 17 million US adults had cancer in 2016-2017 at some point in their lifetime, of whom 12 million were found to have cancer in any given year. This makes up 10.8% of US adults.
As in many other jurisdictions, a relatively small proportion of patients diagnosed and treated for cancer have a familial predisposition (5.1% in this study). Thus, while there is no evidence of a hereditary basis to cancer, some hereditary predispositions to cancer may be identified. As in recent epidemiological studies, cancer survivors, both men and women, are at increased risk of subsequent breast cancer (about two-fold).
The majority of patients with cancer receive at least one type of therapy. Results from a recent paper, most patients received standard therapies such as surgery, chemotherapy, radiation therapy, or targeted therapy. The overall quality of care was low, with only half of the treatment sessions being documented in the medical record. Future studies should examine whether and what constitutes high quality care for cancer treatments.
It is a common belief that the elderly do not want to enroll in clinical trials. Older patients or patients with comorbidities or other disabilities may have a higher risk for participating in clinical trials. Therefore, the possibility of enrollment should be discussed with patients or their primary care physicians.
There have been three other large phase III studies (START-1 (E7771), STOMP-1 (E7772) and STOMP-2 (E7773)) investigating the efficacy of cci-001 in patients with previously untreated metastatic breast cancer (MBC) whose tumors had HER2 overexpression (HER2+) by IHC assay. Overall, the STOMP groups as a whole, and STOMP-1 in particular, reported higher responses with cci-001 than with comparator regimens. However, the STOMP trials did not disclose the time for progression (TTP) or overall survival data.
Cci-001 can be safely administered by intravenous infusion twice every 15 minutes over the next 2 hours. Dose adjustment based on serum creatinine and absolute creatinine clearance do not need to be made. There were no serum or urine changes detected.
The seriousness of cancer depends not only on histology but also on the site and stage of involvement, the person's overall health, their age and other risk factors.