Trial Summary
What is the purpose of this trial?The purpose of this study is to find out whether tinengotinib in combination with abiraterone acetate and prednisone or enzalutamide is a safe treatment that causes few or mild side effects in people with metastatic castration-resistant prostate cancer (mCRPC).
Is the drug Tinengotinib, used with Abiraterone Acetate, a promising treatment for prostate cancer?Yes, Tinengotinib, when used with Abiraterone Acetate, shows promise for treating prostate cancer. Abiraterone Acetate has been proven to extend survival and delay cancer progression in patients with advanced prostate cancer. This combination could potentially enhance treatment effectiveness.12346
What safety data is available for Tinengotinib and standard treatments for prostate cancer?The safety data for the combination of abiraterone acetate (Zytiga) and prednisone, which are part of the standard treatments for prostate cancer, is well-documented. Clinical trials have shown that abiraterone acetate plus prednisone significantly prolongs overall survival and progression-free survival in patients with metastatic castration-resistant prostate cancer (mCRPC). The safety profile of abiraterone acetate has been characterized in various studies, including its association with metabolic and cardiovascular adverse events. However, specific safety data for Tinengotinib (TT-00420) in combination with these treatments is not provided in the available research.12789
What data supports the idea that Tinengotinib + Standard Treatments for Prostate Cancer is an effective drug?The available research shows that abiraterone acetate, a part of the standard treatments for prostate cancer, is effective in treating metastatic castration-resistant prostate cancer. In clinical trials, abiraterone acetate combined with prednisone significantly increased the time patients lived without their cancer getting worse and improved overall survival compared to a placebo. This suggests that the combination of Tinengotinib with these standard treatments could also be effective, although specific data on Tinengotinib itself is not provided in the available research.12345
Do I need to stop my current medications for this trial?You must continue taking either abiraterone acetate or enzalutamide at the full standard dose to participate in this trial. The protocol does not specify stopping other medications, but you should discuss your current medications with the study team.
Eligibility Criteria
This trial is for individuals with metastatic castration-resistant prostate cancer. Participants should not have had previous treatments that failed and must be healthy enough to take the study medications.Inclusion Criteria
I can take care of myself and am up and about more than 50% of my waking hours.
My cancer has worsened despite taking enzalutamide or abiraterone.
I have been on hormone therapy for prostate cancer for at least 90 days or have had both testicles surgically removed.
My prostate cancer diagnosis has been confirmed by a lab test.
My cancer has spread to my bones or soft tissues, confirmed by scans.
Exclusion Criteria
I don't have any stomach or intestine problems that affect medication absorption.
I have brain metastases that are causing symptoms or have not been treated.
I have been treated with drugs that target multiple kinases.
My cancer is diagnosed as pure small cell carcinoma.
I have high blood pressure or chest pain due to heart disease that isn't well-controlled.
I do not have any other cancer that could affect this treatment's safety or results.
I have not had palliative radiation in the last 2 weeks.
I have serious heart issues, including recent heart attack or severe heart failure.
Treatment Details
The trial tests Tinengotinib combined with standard prostate cancer treatments (abiraterone acetate and prednisone or enzalutamide) to see if it's a safe option that only causes mild side effects.
2Treatment groups
Experimental Treatment
Group I: Tinengotinib with abiraterone acetate/prednisoneExperimental Treatment3 Interventions
Tinengotinib will be administered daily for 28-day cycles. A flat dose of 10 mg PO once daily will be administered unless dose de-escalation is required in Phase 1b. Participants will receive tinengotinib in combination with abiraterone acetate 1000 mg PO QD in combination with prednisone 5 mg PO once or twice daily (QD or BID) or enzalutamide 160 mg PO QD.
Group II: Phase 1b dose of tinengotinib (RP2D) with abiraterone acetate/prednisone or enzalutamideExperimental Treatment3 Interventions
Phase 1b dose of tinengotinib recommended Phase II dose (RP2D) with abiraterone acetate/prednisone or enzalutamide
Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Zytiga for:
- Metastatic castration-resistant prostate cancer
- Metastatic high-risk castration-sensitive prostate cancer
🇪🇺 Approved in European Union as Zytiga for:
- Metastatic castration-resistant prostate cancer
- Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer
🇨🇦 Approved in Canada as Zytiga for:
- Metastatic castration-resistant prostate cancer
- Metastatic castration-sensitive prostate cancer
🇯🇵 Approved in Japan as Zytiga for:
- Prostate cancer
Find a clinic near you
Research locations nearbySelect from list below to view details:
Columbia UniversityNew York, NY
Duke UniversityDurham, NC
Thomas Jefferson University HospitalPhiladelphia, PA
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, NJ
More Trial Locations
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
TransThera SciencesCollaborator
References
Abiraterone acetate: a guide to its use in metastatic castration-resistant prostate cancer. [2021]Oral abiraterone acetate (Zytiga®), a selective cytochrome P450 17A1 enzyme inhibitor, is used in combination with prednisone or prednisolone to treat patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel-containing chemotherapy. In a clinical trial in patients with CRPC, abiraterone acetate plus prednisone significantly prolonged overall survival, the time to prostate-specific antigen progression and progression-free survival compared with placebo plus prednisone.
Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary. [2018]On December 10, 2012, the U.S. Food and Drug Administration granted full approval for a modified indication for abiraterone acetate (Zytiga tablets; Janssen Biotech, Inc.) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The approval was based on clinical trial COU-AA-302, which randomly allocated asymptomatic or mildly symptomatic patients with chemotherapy-naïve mCRPC and no visceral metastases to either abiraterone acetate plus prednisone (N = 546) or placebo plus prednisone (N = 542). The coprimary endpoints were radiographic progression-free survival (rPFS) and overall survival (OS). The median rPFS was 8.3 months in the placebo arm and had not yet been reached in the abiraterone acetate arm {HR, 0.43 [95% confidence interval (CI) 0.35-0.52]; P
Retreatment of men with metastatic castrate-resistant prostate cancer with abiraterone. [2016]Abiraterone acetate (AA), oral CYP17 inhibitor, is an active agent in the treatment of metastatic castrate-resistant prostate cancer (mCRPC).
Value of treatment in clinical trials versus the real world: the case of abiraterone acetate (Zytiga) for postchemotherapy metastatic castration-resistant prostate cancer patients in Sweden. [2017]In a randomized clinical trial (COU-AA-301), abiraterone acetate (Zytiga(®)) was shown to be superior to prednisone in the treatment of metastatic castration-resistant prostate cancer (mCRPC). However, the value of abiraterone treatment for patients with mCRPC in clinical practice in Sweden is not known. The aim of this study was to compare the outcomes and treatment patterns of abiraterone treatment in a Swedish observational study to those of the pivotal clinical trial, thereby discussing the external validity of the postchemotherapy clinical trial from a Swedish perspective.
Abiraterone Acetate: A Review in Metastatic Castration-Resistant Prostrate Cancer. [2019]Oral abiraterone acetate (Zytiga®) is a selective inhibitor of CYP17 and thereby inhibits androgen biosynthesis, with androgen signalling crucial in the progression from primary to metastatic prostate cancer (PC) and subsequently, in the development of metastatic castration-resistant PC (mCRPC). In large phase 3 trials and in the clinical practice setting, oral abiraterone acetate in combination with prednisone was an effective treatment and had an acceptable, manageable tolerability and safety profile in chemotherapy-naive and docetaxel-experienced men with mCRPC. In the pivotal global phase 3 trials, relative to placebo (+prednisone), abiraterone acetate (+prednisone) prolonged overall survival (OS) at data maturity (final analysis) and radiographic progression-free survival (rPFS) at all assessed timepoints. Given its efficacy in prolonging OS and its convenient once-daily oral regimen, in combination with prednisone, abiraterone acetate is an important first-line option for the treatment of mCRPC.
Abiraterone in metastatic castration-resistant prostate cancer: Efficacy and safety in unselected patients. [2019]Abiraterone acetate (AA), an androgen biosynthesis inhibitor, is now a standard of care for men with metastatic, castration-sensitive and castration-resistant prostate cancer (mCRPC). Data exploring real-world toxicity and outcomes are scarce.
Pharmacokinetics and bioequivalence of generic and branded abiraterone acetate tablet: a single-dose, open-label, and replicate designed study in healthy Chinese male volunteers. [2022]Abiraterone acetate is a highly variable drug and has been approved for the treatment of patients with metastatic castration-resistant prostate cancer in many countries. This study was conducted to compare the pharmacokinetic profile between the test product (abiraterone acetate tablet) and reference product ZYTIGA® (250 mg) mainly.
Risk of Metabolic and Cardiovascular Adverse Events With Abiraterone or Enzalutamide Among Men With Advanced Prostate Cancer. [2023]Abiraterone and enzalutamide are the most common oral agents for the treatment of men with advanced prostate cancer. To understand their safety profiles in real-world settings, we examined the association between the use of abiraterone or enzalutamide and the risk of metabolic or cardiovascular adverse events while on treatment.
Safety Profile of Ipatasertib Plus Abiraterone vs Placebo Plus Abiraterone in Metastatic Castration-resistant Prostate Cancer. [2023]Adding ipatasertib to abiraterone and prednisone/prednisolone significantly improved radiographic progression-free survival for patients with metastatic castration-resistant prostate cancer (mCRPC) with PTEN-loss tumours by immunohistochemistry in the IPATential150 trial (NCT03072238). Here we characterise the safety of these agents in subpopulations and assess manageability of key adverse events (AEs).