Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Recurrence

Disease Attributes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Pemetrexed

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Albumin-bound paclitaxel injection or Pemetrexed disodium for injection or Gemcitabine for injection

SHR-1210

SHR-1020

Investigators will declare one of the following regimens:Albumin-bound paclitaxel injection, Pemetrexed disodium for injection, Gemcitabine for injection

Physician's choice chemotherapy

This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.

This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.The primary study hypotheses are that the combination of SHR-1210 plus SHR-1020 is superior to SHR-1210 or physician's choice chemotherapy with respect to: 1) Progression free survival(PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus SHR-1210；2) Overall survival(OS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus Physician's choice chemotherapy).

A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer

A Randomized,Open-label, Multi-Center, Phase II Clinical Trial to Assess the Efficacy and Safety of SHR-1210± SHR-1020 Versus Physician's Choice Chemotherapy in the Treatment of Recurrent or Metastatic Cervical Cancer Patients

Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.

PFS is defined as from the time of randomization until the date of first documented progression or date of death from any cause, whichever came first.

OS is the time interval from randomization to death due to any reason or lost of follow-up.

Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions), PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or SD (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria.

For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death from any cause, whichever came first. The DOR per RECIST 1.1 as assessed by Investigator will be presented.

Defined as the time from randomization to the first objective tumor response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters)) observed for patients who achieved a CR or PR.

Defined as the time from randomization to the end of treatment or death from any cause, whichever came first.

To calculate the proportion of dose interruption, dose reduction or dose termination because of drug-related toxicity

Defined as ratio of ADAs of SHR-1210 during the treatment compared to baseline.

Defined as peak serum concentration of SHR-1210 during the treatment compared to baseline

Defined as peak plasma concentration of famitinib during the treatment compared to baseline

Defined as area under the serum concentration versus time curve of SHR-1210 during the treatment compared to baseline

Defined as area under the plasma concentration versus time curve of famitinib during the treatment compared to baseline

Jiangsu HengRui Medicine Co., Ltd.

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Infective Agents

Thalidomide

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

Physician's choice chemotherapy. No constraints of the choice of chemotherapy drugs and regimens.

Investigators will declare no constraint of regimens.

lei lei, master

xiaojia wang, doctor

Xiaojia Wang, PHD

Jian Huang, Doctor

Sixty advanced breast cancer patients are planed to enrolled in this clinical trial. Forty patients are enrolled into thalidomide plus chemotherapy group. Twenty patients are enrolled into chemotherapy alone group. There is no restriction on chemotherapy regimen and lines.

The study compares the combination of thalidomide and chemotherapy with chemotherapy alone for the treatment of stage IV breast cancer. Efficacy and safety of the chemotherapy-thalidomide combination will be evaluated. Assessing the isolated effects of thalidomide in a setting where pre and post treatment serum specimens can be obtained will provide essential information about the mechanisms by which vascular endothelial growth factor(VEGF) inhibition affects tumor growth, and represents an ideal opportunity to evaluate the molecular effects of thalidomide on breast tumor.

Thalidomide Plus Chemotherapy Versus Chemotherapy Alone for Advanced Breast Cancer

Thalidomide Plus Chemotherapy Versus Chemotherapy Alone: A Phase II Study in Advanced Breast Cancer

PFS is defined as the months that from the anticipation of the clinical-trial to the progress of breast cancer.

OS is defined as the months that from the anticipation of the clinical-trial to the death of patients.

Zhejiang Cancer Hospital

Capecitabine

Vinorelbine

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21

Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

Investigators will declare one of the following regimens:

* Capecitabine 2500 mg/m2 po daily (divided in 2 doses) x 14 days, repeat every 21 days
* Vinorelbine 30 mg/m2 IV Day 1 and Day 8, repeat every 21 days
* Eribulin 1.4 mg/m2 IV Day 1 and Day 8, repeat every 21 days

Mark Robson, MD

This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Time from randomisation to the earliest of first subsequent cancer therapy start date following study treatment discontinuation, or death.

Time from randomisation to the earliest of second subsequent cancer therapy start date following study treatment discontinuation, or death.

Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time from randomisation to the earliest of the progression event subsequent to the first objective radiological progression, or death. Second progression may involve any of; objective radiological or symptomatic progression or death. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Symptomatic progression is assessed by investigators based on clinical examination.

Time from randomisation until death due to any cause.

Number of responders according to blinded independent central review (BICR) assessment. Per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response = CR + PR.

Change from baseline in global health status/quality of life (QoL) score assessed using a mixed model for repeated measures (MMRM) analysis, including all post-baseline global health status/QoL scores up to the latest scheduled visit where at least 20 patients on each treatment arm have a score. Global health status/QoL score is on a scale from 0 to 100. A higher score represents an improved health status/QoL.

Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Assessed in patients with a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).

Myriad Genetic Laboratories, Inc.

Merck Sharp & Dohme LLC

AstraZeneca

Adverse events and serious adverse events are reported in the Safety Analysis Set including all patients who received at least one dose of study treatment (n=296). Six patients on the chemotherapy arm did not receive any study treatment and therefore are excluded from the Safety Analysis Set, leaving n=91 patients on the chemotherapy arm. All cause mortality is reported in the Full Analysis Set (n=302).

Olaparib 300 mg bd

Chemotherapy

Total

Age (years)

Age, Continuous

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Global

Region of Enrollment

ER = oestrogen receptor, PgR = progesterone receptor. All patients were HER2 negative.

Receptor status

Received prior chemotherapy for metastatic breast cancer

Received prior platinum for breast cancer

Full analysis set consisting of all randomized patients.

Medical Science Director

Study is sized to provide 90% power to detect a true treatment effect of PFS hazard ratio 0.653.

Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin

Full Analysis Set (FAS) consisting of all randomised patients

Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)

Time to Second Progression or Death (PFS2)

Overall Survival (OS)

Evaluable For Response (EFR) Analysis Set consisting of all randomised patients with measurable disease at baseline, i.e. at least one measurable target lesion assessed by blinded independent central review (BICR)

Objective Response Rate (ORR) Using Blinded Independent Central Review (BICR) Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)

Subset of Full Analysis Set (FAS) consisting of all randomised patients with an evaluable baseline EORTC QLQ-C30 assessment and at least one evaluable post-baseline assessment

Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)

Subset of Full Analysis Set (FAS) consisting of all randomised patients who were confirmed as Myriad CDx gBRCAm

Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) in Patients Confirmed as Myriad CDx gBRCAm

Time to First Subsequent Cancer Therapy or Death (TFST)

Time to Second Subsequent Cancer Therapy or Death (TSST)

Overall Survival (OS) at Final OS

Overall Survival (OS) at Extended OS

Time to First Subsequent Cancer Therapy or Death (TFST) at Extended OS

Time to Second Subsequent Cancer Therapy or Death (TSST) at Extended OS

Overall Study

Apatinib

Fluzoparib

Protein Kinase Inhibitors

Fluzoparib Orally twice daily; Apatinib Orally once daily

Fluzoparib; Apatinib

Investigators will declare one of the following regimens:

Capecitabine Vinorelbine

Quanren Wang

Xiaodi Wang

This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Physicians Choice Chemotherapy, as treatment, in patients with a Germline BRCA Mutation and HER2-negative Metastatic Breast Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.

A Study of Fluzoparib±Apatinib Versus Chemotherapy Treatment of Physician's Choice in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation

A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib±Apatinib Versus Physicians Choice Chemotherapy in the Treatment of HER2-negative Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations

dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle

Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib

Defined as progression free survival per RECIST 1.1 criteria according to BIRC criteria

Adverse Events and Serious Adverse Events

OS is the time interval from the start of treatment to death due to any reason or lost of follow-up

Comparison of the Quality of Life in study arms assessed by EORTC QLQ C30 questionnaire

From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first

Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI

Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1

Time from documentation of tumor response to disease progression assessed among patients who had an objective response

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer	NCT04680988	Recurrent or Me...	SHR-1210 SHR-1020 Physician's cho...	18 Years - 75 Years	Jiangsu HengRui Medicine Co., Ltd.
Thalidomide Plus Chemotherapy Versus Chemotherapy Alone for Advanced Breast Cancer	NCT02649101	Metastatic Brea...	Thalidomide Physician's cho...	18 Years - 65 Years	Zhejiang Cancer Hospital
Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.	NCT02000622	Breast Cancer M... BRCA 1 Gene Mut... BRCA 2 Gene Mut...	Olaparib Physician's cho...	18 Years - 99 Years	AstraZeneca
Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.	NCT02000622	Breast Cancer M... BRCA 1 Gene Mut... BRCA 2 Gene Mut...	Olaparib Physician's cho...	18 Years - 99 Years	AstraZeneca
A Study of Fluzoparib±Apatinib Versus Chemotherapy Treatment of Physician's Choice in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation	NCT04296370	Treatment in HE...	Fluzoparib; Apa... Fluzoparib Physician's cho...	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.
Thalidomide Plus Chemotherapy Versus Chemotherapy Alone for Advanced Breast Cancer	NCT02649101	Metastatic Brea...	Thalidomide Physician's cho...	18 Years - 65 Years	Zhejiang Cancer Hospital
A Study of Fluzoparib±Apatinib Versus Chemotherapy Treatment of Physician's Choice in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation	NCT04296370	Treatment in HE...	Fluzoparib; Apa... Fluzoparib Physician's cho...	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.
Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.	NCT02000622	Breast Cancer M... BRCA 1 Gene Mut... BRCA 2 Gene Mut...	Olaparib Physician's cho...	18 Years - 99 Years	AstraZeneca

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