Anlotinib for Patients With Platinum Resistant or Refract... | NCT03924882

Studies
Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer

NCT03924882

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Apr 23, 2019Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

Ovarian Cancer

Interventions

Anlotinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2019Estimated

Primary Completion Date

Apr 25, 2021Estimated

Completion Date

Apr 25, 2022Estimated

First Submitted Date

Apr 21, 2019

First Submission Date that Met QC Criteria

Apr 21, 2019

First Posted Date

Apr 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2019

Last Update Posted Date

Apr 23, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to evaluate the efficacy and toxicity of anlotinib in patients with platinum resistant or refractory ovarian cancer

Detailed Description

Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. In most cases, the disease is diagnosed at an advanced stage and approximately 75% of patients will eventually experience disease recurrence. However, the overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. Therefore, it is important to seek alternative agent that can improve the outcome. Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets VEGFR,FGFR,PDGFR,and c-kit,. The preclinical studies suggest anlotinib may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of the study drug anlotinib.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
Anlotinib	Drug	Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)	Objective response rate defined as confirmed complete response or partial response under RECIST 1.1 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.	Up to three years

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival (PFS)		Up to three years
Duration of Response		Up to three years
Frequency and severity of adverse effects as defined by CTCAE version 4.03

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female, age ≥18 years and ≤70 years, signed informed consent.
Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy)
At least treated with one line of platinum-based chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version or CA125
Patients must have a life expectancy of at least 3 months.
Patients must have adequate organ function.

Exclusion Criteria:

Had prior exposure to anlotinib or has known allegies to any of the excipients, Inadequately controlled hypertension
History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1
Major surgical procedure within 28 days prior to Day 1, Serious, non-healing wound, active ulcer, bowel obstruction within 28 days prior to Day 1
Symptomatic central nervous system (CNS) metastasis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhigang Zhang, M.D.	Contact	15088621550		zzg2011@zju.edu.cn
Jianwei Zhou, M.D.	Contact	0571-89713634		jianwei-zhou@163.com

Overall Officials

Name	Affiliation	Role
Jianwei Zhou, M.D.	Second Affiliated Hospital, School of Medicine, Zhejiang University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated hospital of Zhejiang University School of Medicine	Recruiting	Hangzhou	Zhejiang	310009	China

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases