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

NCT03942068 | Unknown Phase 2

• 1 other identifier: HR-HenanCH-OC019
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

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

Secondary Outcomes (3)

• OS

  through study completion, an average of 5 year

• PFS

  through study completion, an average of 5 year

• DCR

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

Study Arms (1)

albumin-bound paclitaxel+apatinib

EXPERIMENTAL

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

Drug: albumin-bound paclitaxel; Drug: Apatinib

Interventions

albumin-bound paclitaxel DRUG

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

albumin-bound paclitaxel+apatinib

Apatinib DRUG

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

albumin-bound paclitaxel+apatinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Had prior exposure to apatinib or has known allegies to any of the excipients.
• Patients with trauma, surgical history, gastrointestinal bleeding, and melena within 1 month prior to treatment.
• Inadequately controlled hypertension. 4.History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1.
• Imaging studies suggest that patients with tumors invading important blood vessels.
• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Albumin-Bound Paclitaxel; apatinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 8, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 30, 2020
• Last Updated: May 8, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share