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
• Sponsor: Henan Cancer Hospital
• Information provided by (Responsible Party): Henan Cancer Hospital

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

• 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

• 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

More Information

• Responsible Party: Henan Cancer Hospital
• ClinicalTrials.gov Identifier: NCT03942068
• Other Study ID Numbers: HR-HenanCH-OC019
• First Posted: May 8, 2019
• 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; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Paclitaxel; Apatinib; Albumin-Bound Paclitaxel; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Protein Kinase Inhibitors; Enzyme Inhibitors