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Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Anlotinib

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Anlotinib; Ovarian cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

The Second Affiliated hospital of Zhejiang University School of MedicineRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression-free survival (PFS)

Duration of Response

Frequency and severity of adverse effects as defined by CTCAE version 4.03

Full Information

NCT ID

NCT03924882

First Posted

April 21, 2019

Last Updated

April 21, 2019

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT03924882

Brief Title

Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer

Official Title

A Phase II Study of Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 25, 2019 (Anticipated)

Primary Completion Date

April 25, 2021 (Anticipated)

Study Completion Date

April 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

Keywords

Anlotinib; Ovarian cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Anlotinib

Intervention Description

Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Primary Outcome Measure Information:

Title

Objective response rate (ORR)

Description

Time Frame

Up to three years

Secondary Outcome Measure Information:

Title

Progression-free survival (PFS)

Time Frame

Up to three years

Title

Duration of Response

Time Frame

Up to three years

Title

Frequency and severity of adverse effects as defined by CTCAE version 4.03

Time Frame

30 days after last dose

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhigang Zhang, M.D.

Phone

15088621550

zzg2011@zju.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Jianwei Zhou, M.D.

Phone

0571-89713634

jianwei-zhou@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianwei Zhou, M.D.

Organizational Affiliation

Second Affiliated Hospital, School of Medicine, Zhejiang University

Official's Role

Study Chair

Facility Information:

Facility Name

The Second Affiliated hospital of Zhejiang University School of Medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhigang Zhang, M.D.

Phone

15088621550

zzg2011@zju.edu.cn

First Name & Middle Initial & Last Name & Degree

Jianwei Zhou, M.D.

Phone

0571-89713634

jianwei-zhou@163.com

12. IPD Sharing Statement

Learn more about this trial

Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer

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