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Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

albumin-bound paclitaxel

Apatinib

About this trial

This is an interventional treatment trial for 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.
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.
Imaging confirmed diagnosis of progression occurred after the last treatment before enrollment.
Histologically or pathologically confirmed diagnosis of ovarian cancer as primary tumor.
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Patients must have a life expectancy of at least 3 months.
Patients must have adequate organ function as defined by the following criteria:
White blood cell count ≥ 3 x 10^9/L, Absolute neutrophil count (ANC) (≥ 1.5 x 10^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 70 x 10^9/L, Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2 x ULN, Serum creatinine ≤ 1 x ULN.

Exclusion Criteria:

1.Had prior exposure to apatinib or has known allegies to any of the excipients.
2.Patients with trauma, surgical history, gastrointestinal bleeding, and melena within 1 month prior to treatment.
3.Inadequately controlled hypertension. 4.History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1.
5.Imaging studies suggest that patients with tumors invading important blood vessels.
6.Symptomatic central nervous system (CNS) metastasis. 7.History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

albumin-bound paclitaxel+apatinib

Arm Description

albumin-bound paclitaxel:260mg/m2，q3w，d1 apatinib:500mg，qd，po

Outcomes

Primary Outcome Measures

ORR

Objective Response Rate

Secondary Outcome Measures

Overall Survival

PFS

Progression-Free Survival

DCR

Disease Control Rate

Full Information

NCT ID

NCT03942068

First Posted

May 5, 2019

Last Updated

May 6, 2019

Sponsor

Henan Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03942068

Brief Title

Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer

Official Title

Evaluating the Efficacy and Safety of Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2019 (Anticipated)

Primary Completion Date

September 1, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study was designed to evaluate the efficacy and safety of apatinib with albumin-bound paclitaxel in patients with platinum-resistant recurrent ovarian cancer.

Detailed Description

The study is an open, one-arm, prospec will collect 35 patients with platinum-resistant recurrent ovarian cancer treated with apatinib with albumin-bound paclitaxel from 2019 to 2020 in Henan Cancer Hospital.Antiangiogenic treatments have been implicated to play a major role in ovarian cancer (OC). Apatinib, a novel oral antiangiogenic agent targeting vascular endothelial growth factor receptor (VEGFR2), in combination with weekly paclitaxel, may improve clinical outcomes compared with apatinib or paclitaxel alone in patients with refractory or platinum-resistant ovarian cancer.

6. Conditions and Keywords

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

Ovarian Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

albumin-bound paclitaxel+apatinib

Arm Type

Experimental

Arm Description

albumin-bound paclitaxel:260mg/m2，q3w，d1 apatinib:500mg，qd，po

Intervention Type

Drug

Intervention Name(s)

albumin-bound paclitaxel

Intervention Description

Nanoparticle albumin-bound paclitaxel (nab-paclitaxel), a microtubule inhibitor

Intervention Type

Drug

Intervention Name(s)

Apatinib

Intervention Description

a novel oral antiangiogenic agent targeting vascular endothelial growth factor receptor (VEGFR2)

Primary Outcome Measure Information:

Title

ORR

Description

Objective Response Rate

Time Frame

Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months

Secondary Outcome Measure Information:

Title

Description

Overall Survival

Time Frame

through study completion, an average of 5 year

Title

PFS

Description

Progression-Free Survival

Time Frame

through study completion, an average of 5 year

Title

DCR

Description

Disease Control Rate

Time Frame

Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months

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. 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. Imaging confirmed diagnosis of progression occurred after the last treatment before enrollment. Histologically or pathologically confirmed diagnosis of ovarian cancer as primary tumor. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Patients must have a life expectancy of at least 3 months. Patients must have adequate organ function as defined by the following criteria: White blood cell count ≥ 3 x 10^9/L, Absolute neutrophil count (ANC) (≥ 1.5 x 10^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 70 x 10^9/L, Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2 x ULN, Serum creatinine ≤ 1 x ULN. Exclusion Criteria: 1.Had prior exposure to apatinib or has known allegies to any of the excipients. 2.Patients with trauma, surgical history, gastrointestinal bleeding, and melena within 1 month prior to treatment. 3.Inadequately controlled hypertension. 4.History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1. 5.Imaging studies suggest that patients with tumors invading important blood vessels. 6.Symptomatic central nervous system (CNS) metastasis. 7.History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer

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