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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03942068
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Information provided by (Responsible Party):
Henan Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: albumin-bound paclitaxel Drug: Apatinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy and Safety of Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: albumin-bound paclitaxel+apatinib
albumin-bound paclitaxel:260mg/m2,q3w,d1 apatinib:500mg,qd,po
Drug: albumin-bound paclitaxel
Nanoparticle albumin-bound paclitaxel (nab-paclitaxel), a microtubule inhibitor

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

Primary Outcome Measures :
  1. ORR [ Time Frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months ]
    Objective Response Rate

Secondary Outcome Measures :
  1. OS [ Time Frame: through study completion, an average of 5 year ]
    Overall Survival

  2. PFS [ Time Frame: through study completion, an average of 5 year ]
    Progression-Free Survival

  3. DCR [ Time Frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months ]
    Disease Control Rate

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Female, age ≥18 years and ≤70 years, signed informed consent.
  2. 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).
  3. At least treated with one line of platinum-based chemotherapy.
  4. Imaging confirmed diagnosis of progression occurred after the last treatment before enrollment.
  5. Histologically or pathologically confirmed diagnosis of ovarian cancer as primary tumor.
  6. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version.
  7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  8. Patients must have a life expectancy of at least 3 months.
  9. Patients must have adequate organ function as defined by the following criteria:
  10. 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.

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Responsible Party: Henan Cancer Hospital Identifier: NCT03942068    
Other Study ID Numbers: HR-HenanCH-OC019
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors