Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Ci… (NCT04491942) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer
United States, Canada74 participantsStarted 2021-08-25
Plain-language summary
This phase I trial identifies the best dose, possible benefits and/or side effects of BAY 1895344 in combination with chemotherapy in treating patients with solid tumors or urothelial cancer that has spread to other places in the body (advanced). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cisplatin and gemcitabine are chemotherapy drugs that stop the growth of tumor cells by killing the cells. Combining BAY 1895344 with chemotherapy treatment (cisplatin, or cisplatin and gemcitabine) may be effective for the treatment of advanced solid tumors, including urothelial cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically-confirmed advanced solid tumor with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria, for which cisplatin-based therapy would be considered appropriate, including:
* Non-small cell lung cancer (NSCLC)
* UC
* Penile cancer
* Malignant pleural mesothelioma
* Small cell lung cancer
* Biliary tract cancer
* Esophageal and gastric cancers
* Ovarian cancer
* Endometrial cancer
* Cervical cancer
* Head and neck cancer
* Triple-negative breast cancer (Her2/neu-negative, estrogen receptor \[ER\]/progesterone receptor \[PR\]-negative breast cancer)
* For the expansion cohort of the triplet combination at MTD/RP2D only:
* Patients with histologically confirmed advanced or unresectable urothelial carcinoma are eligible
* The histology should be predominantly urothelial (\>= 50% of sample evaluated contains urothelial histology)
* Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of BAY 1895344 in combination with gemcitabine and cisplatin in patients \< 18 years of age, children are excluded from this study
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Availability of archival FFPE tissue
* Prior cisplatin exposure of \< 300 mg/m\^2. Patients with prior cisplatin treatment must have received last cisplatin treatment \> 6 months prior to enrollment
* Prior treatment with PARP inhibito…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding the right dose of BAY 1895344 and tracking side effects rather than proving the treatment works, what does that mean for what we can realistically expect in terms of benefit versus unknown risk for my specific cancer?
2The trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — is there any chance I could still access BAY 1895344 through a compassionate use program, a related trial, or another pathway you're aware of?
3This trial combines BAY 1895344 with cisplatin, or cisplatin plus gemcitabine — these are already intensive chemotherapy regimens with their own side effects, so how would adding an experimental drug on top of that affect my overall treatment burden and quality of life?
4Given that this trial covers a wide range of advanced cancers with emphasis on urothelial cancer, how relevant do you think the early safety data being gathered here would be to my specific diagnosis, and does it change how you'd think about my treatment options?
5Before considering an experimental combination like this, are there standard-of-care treatments or other clinical trials I should try first, or does my situation make an early-phase study like this a reasonable path to discuss now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events
Timeframe: Up to 28 days after completion of study treatment
2
Recommended phase 2 dose (RP2D) of BAY 1895344
Timeframe: Up to 21 days from treatment start date