Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Immune System Diseases

Prostatic Neoplasms

Hypersensitivity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Docetaxel

Carboplatin

Hormones

Cisplatin

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Tubulin Modulators

Antimitotic Agents

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Protective Agents

Docetaxel combined with platinum-based drugs will be applied every 3 weeks for 6 cycles.

Docetaxel alone will be applied every 3 weeks for 6 cycles.

Docetaxel will be given intravenously 75 mg/m2 every 3 weeks for 6 cycles.

5mg Prednisolone Acetate will be given orally twice a day during treatment.

Prednisolone Acetate

Platinum-based drugs will be given intravenously 70 mg/m2 every 3 weeks for 6 cycles. Cisplatin or carboplatin will be carefully chosen according to each patient's Creatinine Clearance.

Platinum-based drugs

Shun Zhang, MD

Hongqian Guo, MD

Shun Zhang

Hongqian Guo

This randomized controlled trial was designed to evaluate the efficacy and safety of Docetaxel combined with Platinum-based drugs compared with Docetaxel alone for metastatic hormone-sensitive prostate cancer patients carrying DNA repair mutation.

The Efficacy and Safety of Docetaxel Combined With Platinum for Metastatic Hormone-sensitive Prostate Cancer

A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Docetaxel Combined With Platinum-based Drugs Compared With Docetaxel Alone for Metastatic Hormone-sensitive Prostate Cancer Patients Carrying DNA Repair Mutation

Time from treatment initiation to Metastatic Castration-Resistant Prostate Cancer (mCRPC). Patients with metastatic prostate cancer develop PCa progression during androgen deprivation therapy (or after bilateral orchiectomy), meet any of the following criteria was defined as mCRPC. 1)PSA progression (defined as elevated PSA levels(≥1ng/ml) for no less than 2 measurements at least 1 week apart); 2) Radiographic progression in soft tissues, with or without PSA progression, according to RECIST 1.1 criteria; 3) Bone progression (defined as 2 or more new bone lesions on bone scans) with or without PSA progression, according to PCWG.

The survival rate of participants during follow-up time.

Radiographic progression-free survival. The survival of participants without radiographic progression.

PSA progression is defined as elevated PSA levels(≥2ng/ml) for no less than 2 measurements at least 1 week apart.

Time from end of treatment to the time when subsequent anti-tumor therapy is needed.

All grades of adverse events will be recorded according to NCI CTCAE (v.5.0)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Chief Physician

Symptoms and General Pathology

Rare Diseases

Recurrence

Glioblastoma

Glioma

Disease Attributes

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Talazoparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Single fraction, low dose (2Gy) whole brain radiation therapy, followed by combination talazoparib and carboplatin

low dose whole brain radiation, followed by combination talazoparib and carboplatin

Aya Helali, MD, PhD

ECL Kwan, BSc

Tai-Chung Lam, FRCR

Chi-Leung Chiang, FRCR

Tsz-Him So, MBBS

In view of the strong biological rationale of employing PARP inhibition in high grade glioma, the current study purposes testing of talazoparib in a biomarker-enriched group of glioma. Carboplatin will be added to sensitize the tumor to PARP inhibition, and low dose radiation therapy will be applied to increase talazoparib drug penetration through blood-brain barrier. The goal is to estimate the effect size of such combinational treatment approach in recurrent high-grade glioma with DNA damage repair deficiency (dDDR)

Recurrent high grade glioma with dDDR, defined by genomic aberrations associated including IDH mutation, PTEN mutation and "BRCAness" signature as defined by next-generation-sequencing (NGS) based comprehensive genomic profiling, will be enrolled.

Patients will receive treatment in 7-day cycle. D1-4: Oral talazoparib 0.75mg daily; D1: Carboplatin (AUC 1.5). On cycle 1 day 1 low dose whole radiation radiation therapy will be given to increase drug penetration. Primary outcome is 6-month progression free survival (PFS-6) by RANO criteria. The study intended to recruit 33 subjects

Talazoparib - Carboplatin for Recurrent High-grade Glioma With DDRd

Combination Talazoparib - Carboplatin for Recurrent High-grade Glioma With DNA Damage Repair Deficiency (DDRd)

Free from disease progression based on RANO criteria

from date of study enrollment to the date of death from any cause

The percentage of patients with radiologically complete or partial response as determined by the investigator according to RANO criteria

The time interval between the time patient develops radiologically complete or partial response to disease progression according to RANO criteria

The University of Hong Kong

Digestive System Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

Durvalumab

Olaparib

Antineoplastic Agents, Immunological

Olaparib 300 mg twice daily Durvalumab 1,500 mg IV on Day 1

Every 4 weeks

Olaparib 300 mg twice daily

Every 4 weeks

Durvalumab 1,500 mg IV on Day 1

Every 4 weeks

Changhoon Yoo

Changhoon Yoo, MD

First-line gemcitabine plus cisplatin chemotherapy is the standard first-line treatment for unresectable or metastatic advanced biliary tract cancer and the optimal duration of the treatment is not mentioned in current clinical guidelines. In the pivotal phase 3 ABC-02 trial, patients received up to 6 to 8 cycles of treatment and stopped without maintenance and our retrospective study shows no significant benefit of continuing gemcitabine plus cisplatin beyond 6 to 8 cycles. However, the survival outcomes of patients who completed 6 to 8 cycles of gemcitabine plus cisplatin without progression are dismal with progression-free survival from the last dose of the treatment of median 5.2 months in a prior retrospective study. Indeed, there is an unmet clinical need in terms of maintenance therapy for advanced biliary tract cancer without progression to first-line gemcitabine plus cisplatin chemotherapy.

Durvalumab with/without tremelimumab, anti-CTLA4 inhibitor, showed encouraging results in recently presented study for treatment of advanced biliary tract cancer combination with gemcitabine plus cisplatin. Combination of olaparib and durvalumab showed promising results for metastatic HER-2 negative BRCA mutated breast cancer. For DDR gene mutated advanced biliary tract cancer, olaparib plus durvalumab combination may show synergistic effect with better efficacy than olaparib monotherapy. Both olaparib and durvalumab are relatively well tolerated compared to other cytotoxic chemotherapeutic agents. Olaparib may have some degree of myelosuppression, most patients are expected to well tolerate. Although combination of durvalumab and olaparib may cause additional adverse events, these also might be tolerable, considering that there are no overlapping toxicities between durvalumab and olaparib and the safety data for the combination of durvalumab with olaparib. Considering poor prognosis in patients with advanced biliary tract cancer and lack of maintenance treatment following scheduled first-line GemCis, clinical benefits with maintenance olaparib or olaparib plus durvalumab weigh more than the potential risks.

Olaparib With or Without Durvalumab for DDR Gene Mutated Biliary Tract Cancer Following Platinum-based Chemotherapy

Randomized Open-labeled Phase 2 Study of Maintenance Olaparib With or Without Durvalumab for DDR Gene Mutated Advanced Biliary Tract Cancer Following Platinum-based Chemotherapy

Study PI will provide IPD to other researchers per request.

Time interval between randomization and tumor progression or death of any cause

Time interval between randomization and death of any cauase

Any toxicities graded by National Cancer Institute Common Terminology Criteria version 5

objective response rates graded by Response Evaluation Criteria in Solid tumor version 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Efficacy and Safety of Docetaxel Combined With Platinum for Metastatic Hormone-sensitive Prostate Cancer	NCT05461261	Hormone Sensiti... DNA Damage Repa... Chemotherapy Ef... Chemotherapeuti...	Docetaxel Prednisolone Ac... Platinum-based ...	40 Years - 75 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Talazoparib - Carboplatin for Recurrent High-grade Glioma With DDRd	NCT04740190	Recurrent Gliom... Recurrent Gliob... Poly ADP Ribose... PTEN Gene Inact... IDH Mutation	Talazoparib	18 Years -	The University of Hong Kong
Olaparib With or Without Durvalumab for DDR Gene Mutated Biliary Tract Cancer Following Platinum-based Chemotherapy	NCT05222971	Biliary Tract C... DNA Damage Repa...	Durvalumab Olaparib	19 Years -	Asan Medical Center
The Efficacy and Safety of Docetaxel Combined With Platinum for Metastatic Hormone-sensitive Prostate Cancer	NCT05461261	Hormone Sensiti... DNA Damage Repa... Chemotherapy Ef... Chemotherapeuti...	Docetaxel Prednisolone Ac... Platinum-based ...	40 Years - 75 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Spots Global Cancer Trial Database for dna damage repair deficiency