Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Olaparib

Tubulin Modulators

Antimitotic Agents

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Treat 15 patients, single dose olaparib 300mg followed by multiple dose olaparib 300mg twice a day

Treat 15 patients, single dose olaparib 100mg followed by multiple dose olaparib 100 mg twice a day and then in combination with paclitaxel (80mg/m2 weekly on days 1, 8 and 15 of a single 28-day cycle)

Binghe Xu, MD

Jianming Xu, MD

Jianzhong Shentu

This is a 2 parts phase I, open label trial of olaparib monotherapy and olaparib in combination with paclitaxel in patients with solid tumours. Part A will assess the single and multiple dose pharmacokinetics of olaparib monotherapy and multiple dose pharmacokinetics of olaparib in combination with paclitaxel. Part B will assess the safety of multiple doses of olaparib in Cohort 1 and of olaparib when co-administered with paclitaxel in Cohort 2

Part A will access the pharmacokinetics of olaparib: Cohort 1 will investigate the single and multiple dose pharmacokinetics of olaparib following 300mg bd monotherapy dose(s); Cohort 2 will investigate the single and multiple dose pharmacokinetics of olaparib following 100mg bd monotherapy dose(s) and the multiple dose pharmacokinetics in the presence of co-administered paclitaxel (80mg/m2 weekly on days 1, 8 and 15 of a single 28-day cycle).

In Part B: Safety profile of olaparib 300mg bd as monotherapy and olaparib 100mg bd in combination with weekly paclitaxel will also be investigated in Chinese patients.

The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour.

A Phase I, Open Label, 2 Part Study to Determine the Pharmacokinetics of Olaparib 300 mg bd Administered as Monotherapy and Olaparib 100 mg bd as Monotherapy and in Combination With Paclitaxel in Chinese Patients With Advanced Solid Tumours

Single dose PK parameter summary for olaparib in monotherapy by dose - Cmax (PK analysis set)

Single dose PK parameter summary for olaparib in monotherapy by dose - AUC (PK analysis set)

Single dose PK parameter summary for olaparib in monotherapy by dose - tmax (PK analysis set)

Single dose PK parameter summary for olaparib in monotherapy by dose - t1/2, λz (PK analysis set)

Single dose PK parameter summary for olaparib in monotherapy by dose - Vz/F (PK analysis set)

Single dose PK parameter summary for olaparib in monotherapy by dose - CL/F (PK analysis set)

Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - Cmax, ss and Cmin, ss (PK analysis set)

Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - AUC (PK analysis set)

Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - tmax, ss (PK analysis set)

Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - RAC and TCP (PK analysis set)

Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - CLss/F (PK analysis set)

AstraZeneca

Cohort 1 Part A

Part A Cohort 2 patients, who have received olaparib 100 mg monotherapy treatment

Cohort 2 Part A, Olaparib 100 mg

Part A Cohort 2 patients, who have received olaparib 100 mg + paclitaxel treatment

Cohort 2 Part A, Olaparib 100mg in Combination With Paclitaxel

Cohort 1 Part B

Part B Cohort 2 patients, who continued on Olaparib 300mg monotherapy after completed combination therapy

Cohort 2 Part B, Olaparib 300 mg Monotherapy

Part B Cohort 2 patients, who have received olaparib 100 mg + paclitaxel treatment

Cohort 2 Part B, Olaparib 100mg in Combination With Paclitaxel

Cohort 1

Olaparib 100 mg bd in combination with paclitaxel

Cohort 2

Total

Age, Continuous

<50 years

≥50 <65 years

≥65 <75 years

≥75 years

Age, Customized

Sex: Female, Male

Chinese

Race/Ethnicity, Customized

Height

Weight

Body mass index

Gershon Locker

PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.

Single Dose PK Parameter--Cmax

AUC0-12

AUC0-t

Single Dose PK Parameter--AUC

Single Dose PK Parameter--tmax

Single Dose PK Parameter--t1/2, λz

Single Dose PK Parameter--Vz/F

Single Dose PK Parameter--CL/F

Cmax, ss

Cmin, ss

Cohort 2 patients with olaparib 100 mg alone dosed

Cohort 2 (Olaparib Alone)

Steady State PK Parameter--Cmax, ss and Cmin, ss at Day 8

AUCss

Cohort 2, Olaparib Alone

Steady State PK Parameter--AUCss at Day 8

Steady State PK Parameter--tmax, ss at Day 8

Steady State PK Parameter--RAC and TCP at Day 8

Cohort 2 patients with Olaparib 100 mg dosed in combination with paclitaxel

Cohort 2(Olaparib 100 mg + Paclitaxel)

Steady State PK Parameter--Cmax, ss and Cmin, ss at Day 9

Steady State PK Parameter--AUCss at Day 9

Steady State PK Parameter--tmax, ss at Day 9

Steady State PK Parameter--CLss/F at Day 8

Part A

Part B

Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Recurrence

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Doxorubicin

Liposomal doxorubicin

Topotecan

Topoisomerase I Inhibitors

Participants will receive CAELYX 50 mg per square meter intravenously on Day 1 of each cycle as: 60 to 90-minute infusion to the participants not undergoing pharmacokinetic (PK) evaluation and 90-minute infusion to the participants undergoing PK evaluation.

Participants will receive topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.

CAELYX 50 mg per square meter will be administered intravenously on Day 1 of each cycle as: 60 to 90-minute infusion to the participants not undergoing pharmacokinetic (PK) evaluation and 90-minute infusion to the participants undergoing for PK evaluation.

CAELYX

Topotecan 1.25 mg per square meter per day will be administered, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.

Topotecan HCl

Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

The purpose of this study is to compare the effectiveness between CAELYX and topotecan hydrochloride (HCl) in Chinese participants with recurrent epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy, who have received no more than one prior platinum-based regimen therapy.

This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), comparative bridging study (a supplemental study which performs to provide data of effectiveness, safety, and dosage to compare two study medications in a new region). The study consists of 3 phases: screening phase (30 days before administration of study medication), treatment phase, and follow up phase (every 8 weeks for tumor assessment until disease progression or death, or until the study completion, whichever is earlier and every 3 months after disease progression for overall survival and for anti-tumor therapy for a minimum of 1 year). In the treatment phase, approximately 120 eligible participants will be categorized prospectively for platinum-sensitivity (sensitive versus refractory) and bulky disease (presence versus absence). Later on participants will be randomly assigned either to experimental arm (CAELYX: administer on Day 1 of each cycle) or control arm (topotecan HCl: administer on Day 1 to Day 5 of each cycle). Treatment will continue until disease progression occurs and may continue for at least 2 cycles after confirmed complete response (disappearance of all target lesions). On average, it is expected that participants will continue treatment for approximately 3 to 6 cycles in experimental arm (CAELYX) or 4 to 8 cycles in Control arm (topotecan HCl). Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, echocardiogram (or multiple gated acquisition scans), vital signs, and physical examination which will be monitored throughout the study. The total duration of the study will be approximately 23 months.

A Study to Compare CAELYX With Topotecan HCL in Patients With Recurrent Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy

A Phase 3, Randomized, Open-Label, Comparative Bridging Study of CAELYX® Versus Topotecan HCl in Subjects With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy

Progression-free survival incidence was be measured as number of participants who were progression-free and alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) 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.

It was calculated as the time, in weeks, from the day of randomization until documented disease progression or death due to any cause, whichever occurs first using a Kaplan-Meier curve for PFS.

Response rate was measured as number of participants with at least a durable response: Complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all target lesions. Partial response is defined as at least a 30 percentage decrease in the sum of diameters of target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progression in disease is defined as at least a 20% increase in the sum of diameters of target lesions. Not evaluable participants were those who were not analyzed. The reference of the baseline sum of diameters of lesions was considered.

It is calculated as the day of randomization to the first observation of a durable response (the first of the 2 confirmatory measurements).

It is calculated as the first observation of a durable response (the first of the 2 confirmatory measurements) to the first observation of disease progression or death due to any cause.

Calculation of each HQL domain scale will be performed according to the scoring guidelines for each of the HQL measures. The HQL analyses will include scales measuring physical functioning, pain, nausea, fatigue, and global quality of life. Each item is measured on a scale of 0 to 3, where 0 = no impact on quality of life and 3 = extreme impact on quality of life.

Number of Participants With Overall survival were categorized as number of 1) Deaths, 2) Still alive, 3) Early termination from the study due to lost to follow up, 4) Early termination from the study due to withdraw of consent, 5) Other. Overall survival is defined as the time interval from randomization to death from any cause.

An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grade 3 (Severe) events are symptoms causing inability to perform usual social \& functional activities. Grade 4 (Life-threatening) events are Symptoms causing inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death.

Xian-Janssen Pharmaceutical Ltd.

Safety population included all randomized participants.

Participants received 50 milligram per square meters (mg/m\^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.

Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.

Topotecan Hydrocloride (HCl)

The modified intent-to-treat population included (mITT) included all randomized participants.

The study was terminated early as the total number of participants treated in this study was low and only descriptive analysis was used for efficacy and safety evaluation.

Senior Director Clin Development

Number of Participants With Progression-free Survival Incidence at Week 24

The mITT population included all randomized participants.

Duration of Progression-free Survival

Complete Response (CR)

Partial Response (PR)

Stable Disease (SD)

Progression Disease (PD)

Not Evaluable (NE)

Number of Participants With Response

The mITT population included all randomized participants.Time to response was analyzed for participants who achieved response.

Time to Response

The mITT population included all randomized participants. Duration of response was analyzed for participants who achieved response.

Duration of Response

Data was not collected for this outcome measure as the study was early terminated.

Health-related Quality of Life Assessment (HQL)

Death

Still alive

Early termination: due to lost to follow up

Early termination: due to withdraw of consent

Other

Number of Participants With Overall Survival

Maximum Plasma Concentration of CAELYX

Time to Reach the Maximum Plasma Concentration of CAELYX

Area Under the Plasma Concentration of CAELYX

Apparent Terminal Elimination Half-life of Plasma Concentration of CAELYX

Apparent Terminal Elimination Rate Constant of Plasma Concentration of CAELYX

Systemic Clearance of Plasma Concentration of CAELYX

Apparent Volume of Distribution of Plasma Concentration of CAELYX

TEAEs

TESAEs

Number of Participants With Adverse Events

Overall Study

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Bortezomib

Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks.

This is an observational study. Velcade will be administered as per the recommended regimen. (Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks)

No intervention

The purpose of this study is to acquire information on the usage, effectiveness, safety, and levels of health care resource utilization associated with Velcade therapy in recurrent and refractory multiple myeloma patients who are initiating Velcade and various combination therapies within the approved indication in a naturalistic setting.

This is a national, multi-center (study conducted in multiple sites), non-interventional (a scientific study where one or more investigators monitor one or more patients being treated with the same medication), observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) of Chinese Multiple Myeloma patients treated with Velcade. The study consists of 3 phases, including, screening phase, treatment phase, and follow up phase. In the screening phase, data will be collected on the basis of patient's demographic status, components of disease severity assessment, and potential prognostic factors. Data on prior cancer treatments will be collected retrospectively at baseline for patients receiving cancer treatment prior to receiving Velcade. In the treatment phase, Velcade is administered intravenously for a 2-week treatment period followed by a 10-day rest period. Each treatment cycle consists of 21 days. Prospective (in which the participants are first identified and then followed forward as time passes) observational data will be collected during treatment with Velcade. In the follow up phase, patients will be followed for up to three years to document long-term survival data. For patients who reinitiate Velcade, data collection should follow Velcade treatment period documentation process. Safety evaluations will be based on the incidence, intensity, and types of adverse events. The total duration of the study is set prospectively for three years from the date of the patients' initiation of Velcade.

An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade

Velcade (Bortezomib for Injection) Observational Study

Treatment sequence or the line of therapy will be considered on Velcade utilization.

Dosage of Velcade will be considered on Velcade utilization. The unit of dosage will be milligram per square meter body surface area.

Duration of Velcade therapy will be measured on Velcade utilization. The unit of duration will be number of days or the length of the course of therapy.

Diagnosis of patients will be considered on Velcade utilization.

Complete response (CR), near complete response (complete response with positive immunofixation; nCR), partial response (PR), minimal response (MR), stable disease (SD), progressive disease (PD), or relapse from CR (RCR); the methods and criteria used to evaluate the responses will be chosen by the physician and recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour.	NCT02430311	Advanced Solid ...	Olaparib Paclitaxel Olaparib	18 Years - 130 Years	AstraZeneca
A Study to Compare CAELYX With Topotecan HCL in Patients With Recurrent Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy	NCT01840943	Epithelial Ovar...	CAELYX Topotecan HCl	18 Years -	Xian-Janssen Pharmaceutical Ltd.
An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade	NCT01675245	Multiple Myelom...	No intervention	- 18 Years	Xian-Janssen Pharmaceutical Ltd.
A Study of Trabectedin (YONDELIS) in Patients With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma	NCT01692678	Advanced or Met...	Trabectedin Dacarbazine	15 Years -	Xian-Janssen Pharmaceutical Ltd.
Study of Efficacy and Safety of CML-CP Patients Treated With Asciminib Versus Best Available Therapy, Previously Treated With 2 or More Tyrosine Kinase Inhibitors	NCT04795427	Leukemia, Chron...	asciminib best available ...	18 Years -	Novartis
A Study to Compare CAELYX With Topotecan HCL in Patients With Recurrent Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy	NCT01840943	Epithelial Ovar...	CAELYX Topotecan HCl	18 Years -	Xian-Janssen Pharmaceutical Ltd.
A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC	NCT04452877	Carcinoma, Non-...	Dabrafenib Trametinib	18 Years -	Novartis

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