Anyone know anything more regarding this?
berzosertib : Anyone know anything more... - Advanced Prostate...
berzosertib
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TheTopBanana
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20 Replies
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It's just a Phase 1 trial - I ignore them.
Hey, wait a second, I thought you only ignored mouse trials.
LOL- that too. I also ignore most observational studies. I try to stay focussed on stuff that patients can and should actually use. There are literally thousands of clinical trials for prostate cancer, and almost all of them won't even make it to Phase III. I do admire those who are willing to risk being in a clinical trial - I did it myself, several times.
Are there any current clinical trials for mCRPC that are exciting or interesting to you ?
I often look at Germany because they are less strict about using unapproved therapies. I'm hoping that radionuclide therapy targeted at FAPI will be a game changer.
for mPC?
do you recommend any article about it?
I wouldn't ignore this one. This is a Very Serious Institute, and these are Very Serious People. Top UK oncologists - I would jump in if I needed it, and camp on the doorstep until I got it.
You will be camping for many years. If you live near one of the test sites, and you are one of the 65 men randomized to get it, you can get it now. If not, the Phase II trial just to show a signal won't be done until the end of next year. If that is successful (most aren't), Phase III trials will probably run another 5 years. Trials for ovarian cancer are further along, so it may be available sooner if you can afford the off-label pricetag.
There is a phase II clinical trial recruiting patients with mCRPC
clinicaltrials.gov/ct2/show...
Tango, what are the general restrictions of the trials other than being mCRPC?
George
"Criteria
Inclusion Criteria:
Participants must have histologically or cytologically confirmed prostate cancer
Patients must have metastatic disease by bone scan or other nodal or visceral lesions on computed tomography (CT) or magnetic resonance imaging (MRI) and a castrate level of testosterone (< 50 ng/dL) and evaluable for disease response by either
Baseline PSA >= 2.0 ng/mL OR
Measurable disease per RECIST 1.1
NOTE: Subjects must maintain a castrate state; if they have not had an orchiectomy, they must continue to receive luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH) agonists or antagonists unless intolerant
At least 2 prior treatments for castration resistant prostate cancer as follows:
Past progression or intolerance to at least one secondary hormonal therapy (abiraterone, enzalutamide, galeterone, apalutamide, darolutamide, orteronel, seviteronel or equivalent)
Past progression or intolerance to taxane-based chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Leukocytes >= 3,000/mcL
Absolute neutrophil count >= 1,500/mcL
Platelets >= 100,000/mcL
Total bilirubin =< 1.5 x institutional upper limit of normal, unless the subject has known or suspected Gilbert's syndrome
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal or =< 5 x if presence of liver metastases
Creatinine clearance >= 40 mL/min/1.73 m^2
Prior treatment with mTOR inhibitors, cytostatic tyrosine kinase inhibitor (TKI), or biologic therapies allowed
Prior treatment with PARP inhibitors permitted
Patients with allergy or intolerance to docetaxel, grade 2 neuropathy or ECOG performance status (PS) = 2 are allowed on study, but if randomized to Arm A will receive carboplatin as a single agent (AUC 5) rather than docetaxel + carboplatin; they must be fit for carboplatin chemotherapy as determined by the treating investigator
Willing to undergo core biopsy of a recurrent/metastatic lesion adequate for next generation sequencing (NGS) after trial registration but prior to cycle 1 day 1 of therapy; confirmation of adequacy of this biopsy material for NGS is NOT required for initiation of therapy; if elective biopsies are not being performed at the treating institution due to preparations or precautions related to Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COVID-19), this requirement can be waived on discussion with the trial principal investigator (PI)
The effects of M6620, carboplatin and docetaxel on the developing human fetus are unknown; for this reason and because DNA-damage response inhibitors and chemotherapeutic agents are known to be teratogenic, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of carboplatin and M6620 administration
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to planned cycle 1 day 1 of study treatment; patients on an oral anti-neoplastic such as an oral hormonal agent, PARP inhibitor or oral experimental agent should discontinue >= 14 days prior to planned cycle 1 day 1 of study treatment
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1), except for grade 2 anorexia, alopecia, neuropathy, and fatigue, for which resolution is not required
Patients who are receiving any other investigational agents
Patients with known brain metastases or leptomeningeal disease should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
History of allergic reactions attributed to compounds of similar chemical or biologic composition to M6620 or carboplatin; (patients with allergy to docetaxel will be allowed on study, but docetaxel will be excluded from their treatment regimen)
Subjects receiving treatment with ototoxic or nephrotoxic medications that cannot be discontinued at least 7 days before first dose of carboplatin and for the duration of the study; inadvertent or short-term use on study will not cause a subject to be ineligible; if a short course of therapy with nephrotoxic or ototoxic medication is anticipated and required, carboplatin should be discontinued until 7 days after this course is completed
M6620 is primarily metabolized by CYP3A4; therefore, concomitant administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir and saquinavir) or inducers of CYP3A4 (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, St. John's wort) should be avoided; because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of; (patient Drug Information Handout and Wallet Card) should be provided to patients; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant and nursing women are excluded from this study because they do not develop prostate cancer
Human immunodeficiency (HIV)-positive participants with detectable viral load and/or CD4 count =< 300 are ineligible due to increased risk of lethal infections when treated with marrow-suppressive therapy; HIV-positive patients with undetectable viral loads and CD4 counts > 300, and not on interacting antiretroviral therapy may be eligible after discussing with the principal investigator
Prior treatment with platinum-containing regimen or ATR inhibitor for prostate cancer
"
Best of luck!!
Tang
Promising. Thanks
Initial human trials have had a good degree of success. Bring it on! Sounds very promising
Not the article desired, which is on a new form of abiraterone
Yes this is another, I’ll e-mail you the one about abiraterone tonight!
Actually, originated the link in this post and the new Abiraterone formulation:
healthunlocked.com/advanced...
Yes that study was the article KWman asked me to find and send as a PDF. If any one else wants it let me now!
I think I found some of that under the nail of my big toe.... (bluish and glows in the dark)...
Good Luck, Good Health and Good Humor.
j-o-h-n Friday 06/26/2020 7:55 PM DST
