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出境医 / 临床实验 / Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer

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

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.

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.
Study Design
Layout table for study information
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
Arms and Interventions
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)
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE May 5, 2019
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date May 8, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • OS [ Time Frame: through study completion, an average of 5 year ]
    Overall Survival
  • PFS [ Time Frame: through study completion, an average of 5 year ]
    Progression-Free Survival
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer
Official Title  ICMJE Evaluating the Efficacy and Safety of Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • 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)
Study Arms  ICMJE Experimental: albumin-bound paclitaxel+apatinib
albumin-bound paclitaxel:260mg/m2，q3w，d1 apatinib:500mg，qd，po
Interventions:
  • Drug: albumin-bound paclitaxel
  • Drug: Apatinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 6, 2019) 		35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03942068
Other Study ID Numbers  ICMJE HR-HenanCH-OC019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Henan Cancer Hospital
Study Sponsor  ICMJE Henan Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Henan Cancer Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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