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Genital Diseases, Male

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Talazoparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

At the time of registration, patients will be assigned to the specific dose-schedule of talazoparib and pidnarulex depending on where the study is at in terms of dose-escalation or dose-expansion

Pidnarulex is a treatment that is designed to stop the action of a particular protein in the body called Polymerase I, that cancer cells rely on. Laboratory studies show that pidnarulex targets a process involving Polymerase I within cells, which can lead to a decrease in cancer growth. Pidnarulex has been shown to have some anticancer activity in ovarian cancer and haematological cancers.

Pidnarulex

Talazoparib belongs to a class of drugs called PARP inhibitors, which is currently being used to treat various types of cancer. Talazoparib blocks the function of PARP, a protein that is involved in repairing DNA in cells. By stopping damaged DNA in cells from being repaired, this will lead to accumulation of DNA damage in the cancer cell and ultimately cancer cell death. Talazoparib has established anticancer activity in breast, ovarian and prostate cancers with underlying DNA repair defects. This class of drug have also been used in combination with other treatments such as radiation or chemotherapy to further increase cell death within the cancer.

Shahneen Sandhu

This is phase I, open label, multicentre, dose-escalation study where both doses of talazoparib and pidnarulex will be escalated to define the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for the combination. It is possible that either 1 or 2 RP2D of the combination will be defined at the end of the study. Patients with disease that is deemed to be amendable to repeated tumour biopsies will be invited to undergo optional paired biopsies: at baseline and Cycle 1 Day 9 + 3 days and at the time of progression. Pidnarulex will be given as an IV infusion on days 1 and 8 of a 28 day cycle and talazoparib will be taken once daily continuously. Disease status will be assessed at regular intervals by CT scans, radionuclide bone scans, and PSA. Throughout the study, safety and tolerability will be assessed and established procedures for management of toxicities will be applied

This is phase I, open label, multicentre, dose-escalation study where both doses of talazoparib and pidnarulex will be escalated to define the MTD and RP2D for the combination.

Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer

Phase 1 Trial of Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer

The radiographic progression will be assessed by the Investigator per RECIST1.1 for soft tissue and PCWG3 for bone lesions. A patient who begins a new systemic anti-cancer treatment for clinical progression without documented radiographic progression will be censored at the time of initiation of new treatment. For patients alive who have no radiographic progression, the time will be censored at the date of last radiographic evaluation. The time will be censored at the date of treatment initiation for patients with no post-baseline radiographic evaluation.

(Patients who died of non-cancer causes without progression will be censored on the date of their last tumour assessment. A patient who begins a new systemic anticancer treatment for clinical progression without documented radiographic progression per RECIST1.1 for soft tissue and PCWG3 for bone lesions will be censored at the time of initiation of new treatment).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer	NCT05425862	Metastatic Cast...	Pidnarulex Talazoparib	18 Years -	Peter MacCallum Cancer Centre, Australia
Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer	NCT05425862	Metastatic Cast...	Pidnarulex Talazoparib	18 Years -	Peter MacCallum Cancer Centre, Australia

Spots Global Cancer Trial Database for pidnarulex

Every month we try and update this database with for pidnarulex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pidnarulex

Every month we try and update this database with for pidnarulex cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pidnarulex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.