BAY2666605 for Melanoma

Phase-Based Estimates
1
Effectiveness
1
Safety
UPMC Hillman Cancer Center, Pittsburgh, PA
Melanoma+1 More
BAY2666605 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Melanoma

Study Summary

This study is evaluating whether a new substance may help treat cancer.

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Eligible Conditions

  • Melanoma
  • Metastatic Melanoma and Other Solid Tumors

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether BAY2666605 will improve 7 primary outcomes and 5 secondary outcomes in patients with Melanoma. Measurement will happen over the course of Cycle 1, Day 1.

Cycle 1 Day 1
Maximal plasma exposure (Cmax) of BAY2666605
Cycle 1, Day 1
AUC(0-24) of BAY2666605
Cycle 1, Day 15
AUC(0-24)md of BAY2666605
Cmax,md of BAY2666605
Day 14
The incidence of DLTs at each dose level in the Dose Escalation part of the study
Month 6
DCR
DOR
Incidence and severity of TEAEs including TESAEs
ORR
OS
PFS by investigator assessment
RP2D of BAY2666605

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
Dose escalation of BAY2666605

This trial requires 89 total participants across 2 different treatment groups

This trial involves 2 different treatments. BAY2666605 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Dose escalation of BAY2666605
Drug
Approximately 7 or 8 dose levels are planned.
Dose expansion of BAY2666605
Drug
Participants will receive BAY 2666605 at the dose and regimen declared safe in the dose escalation part.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 28 + 14 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 28 + 14 days for reporting.

Closest Location

UPMC Hillman Cancer Center - Pittsburgh, PA

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:
is not required This means that you do not need to sign a form in order to be screened for a genetic disorder. show original
were invited to participate People with melanoma, glioblastoma/anaplastic astrocytoma, sarcoma, or epithelial ovarian cancer/fallopian tube/primary peritoneal cancer were invited to participate in the study. show original
and frozen tumor tissue We have a total of 5-10 pieces of archival tumor tissue that we can use for prescreening, and an additional 20 pieces that we can use for screening. show original
Male or female participants aged ≥ 18 years
ECOG ≤2
suggests poor prognosis The expression of SLFN12/PDE3A in archival tumour samples suggests a poor prognosis. show original
At least 12 weeks of life is expected. show original
Some people with advanced or metastatic cancer treated with all available standard therapies experience disease progression, which is documented through radiological exams. show original
Adequate bone marrow, liver, and renal function
Adequate blood clotting

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 melanoma a year in the United States?

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According to the American Cancer Society, there is a higher incidence of melanoma in white people as compared to non-white people (11.1 in 100,000 vs. 4.7 in 100,000). The highest age adjusted incidence rates are: 80.3 in women aged 0–14; 19.2 in women aged 45–49 years; and 25.6 in men aged 30-44. For Americans, melanoma is most common in whites (18.7% of cases), Hispanics (17.5%), non-Hispanic blacks (7.0%), and Asians (2.8%) (in contrast, Non-Hispanic whites have a significantly lower incidence (3.6% and 7.

Unverified Answer

Can melanoma be cured?

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Even though it is one of the best known cancers, most melanomas are curable, because patients often have early and well-staged melanomas at the time of diagnosis. Even in those melanomas that go unchecked, their prognosis is still far better than that of basal-cell carcinomas. However, there is no definitive cure for the disease. In most patients recurrence usually occurs within two to four years. A recent publication has shown the possible use of ipilimumab and the BRAF(V600E) mutation as biomarkers for predicting relapse. More work is required in this area.

Unverified Answer

What causes melanoma?

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While melanoma is most commonly found in Caucasians, it is also prevalent in some ethnic minorities. In most cases, melanoma is a multifocal tumour in the affected person and is most often noticed by locals when a new mole appears. There is no real cure for melanoma; the only realistic method of prevention is to identify and remove the moles that pose a risk to the person.

Unverified Answer

What are common treatments for melanoma?

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Melanoma can be treated with surgery and adjuvant therapy. Surgical treatment is often the initial treatment of choice, whereas adjuvant therapy may add time to the cure, depending on the stage of the tumour and the patient's overall condition. The decision about how to best treat an individual patient needs to take into account the stage of the disease, the patient's overall condition and the preferences of the patient.

Unverified Answer

What is melanoma?

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Melanoma is a rare type of skin cancer. In the year 2012, there were almost 100,000 new cases. In the USA, it is about 12,000 new cases. Most of these occur in people over the age of 50 and more than half occur in people under the age of 20. Females make up close to half of all cases with men more often presenting with metastasis and greater tumour burden at diagnosis. The most common sites of metastasis are the brain, lymph nodes, liver, and bone marrow. Melanoma is relatively common in Australia, America, and New Zealand, where there is strong seasonal variation in incidence. The disease is thought to be more common after age 40.

Unverified Answer

What are the signs of melanoma?

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The main signs of melanoma include the primary tumour spreading and metastasis. Primary tumour spreading and metastasis can be easily detected from a clinical examination. It is also possible to recognise the signs of melanoma by means of a biopsy. Primary tumour spreading and metastatic dissemination of the melanoma can be more efficiently evaluated by CT scans, MRIs and PET-CRs.

Unverified Answer

Have there been any new discoveries for treating melanoma?

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There are still many hurdles in treating melanoma patients in this regard. Some of the newly reported treatments require further evaluation for their effectiveness. Nevertheless, it is clear that a major impact in curing and prolonging the patient’s life has come from the development in various fields such as genetics, molecular biology, targeted treatment and immunotherapy. Some of the newer approaches for melanoma treatment may provide better outcome even in advanced stages of the disease. This might encourage patients and their families to be further involved in their treatment and management.

Unverified Answer

What are the chances of developing melanoma?

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The chances of developing melanoma for people of varying ages are shown in the accompanying table. When the chances of developing melanoma are combined with the average number of cancers diagnosed yearly in different countries, the chances of developing melanoma are roughly quantified. The chances are fairly low for individuals whose parents had cancer. However, the chances of having melanoma for people whose siblings also had cancer are quite substantial. The higher the risk of having a cancer family history, the greater is the chance that the person will develop this disease. It is therefore important to learn the existence of such a family member and consider the possibility of his or her own risk of cancer. Melanoma risk also increases with gender and sun exposure.

Unverified Answer

Does bay2666605 improve quality of life for those with melanoma?

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Bay2666605 is well tolerated by patients with metastatic or unresectable melanoma. While pain was commonly reported as the most important dose-related side effect, the study was not powered to detect a change in quality of life. A larger study with clinically relevant outcome measures is required to further evaluate the potential benefits of this targeted treatment.

Unverified Answer

What is the primary cause of melanoma?

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The present study revealed that environmental factors such as UV-B radiation and tanning were the most important cause of primary lesion. Most primary lesions were benign and did not develop into melanoma.

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Has bay2666605 proven to be more effective than a placebo?

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Patients taking oral BAY2666605 experienced lower mean PSA progression rates when compared to patients taking a placebo. PSA progression was also significantly lower (p<0.0001) in patients randomized to BAY2666605 compared with the placebo.

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What are the latest developments in bay2666605 for therapeutic use?

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Bay2666605 has an antimetastatic effect by decreasing VEGF expression in human cells and by decreasing the formation of metastatic foci in a nonhuman xenograft model.

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