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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03942068

Recruitment Status Not yet recruiting

First Posted May 8, 2019

Last update posted May 8, 2019

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:Ovarian Cancer
  • Intervention/Treatment: Drug: albumin-bound paclitaxel
    Drug: Apatinib
  • Phase: 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
  • Study Type: Interventional
  • Estimated Enrollment: 35 participants
  • 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 2019
  • Estimated Primary Completion Date: September 2020
  • Estimated Study Completion Date: December 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
  • Ages Eligible for Study: 18 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
Contacts
Locations
Sponsors and Collaborators

Henan Cancer Hospital

More Information
  • Responsible Party: Henan Cancer Hospital
  • ClinicalTrials.gov Identifier: NCT03942068 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Ovarian Neoplasms Carcinoma, Ovarian Epithelial