Nab-paclitaxel Combined With Bevacizumab in the Treatment of Metastatic Neuroendocrine Carcinoma

January 9, 2021 updated by: Shen Lin, Peking University

A Prospective, Non-randomized, Multicenter, Phase II Study of Nab-paclitaxel Combined With Bevacizumab for Unresectable Recurrent or Metastatic Neuroendocrine Carcinoma

This is an open-label, phase II study evaluating efficacy and safety of Nab-paclitaxel Combined With Bevacizumab for unresectable Recurrent or metastatic neuroendocrine carcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nab-paclitaxel Combined With Bevacizumab will be evaluated in participants who have had ≥ 1 line of previous treatment. The primary endpoint is the Overall Survival (OS).

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who provided written informed consent to be subjects in this trial
  2. Aged ≥18 years
  3. Has histologically-confirmed diagnosis of locally advanced unresectable or metastatic neuroendocrine carcinoma
  4. Has received and progressed on ≥1 prior systemic therapy for their advanced disease.
  5. Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  6. Have measurable disease as defined by RECIST 1.1 as determined by investigator assessment
  7. Agree to provide tumor tissue sample deemed adequate for histopathology confirmation

  8. Adequate Organ Function Laboratory Values:

    Hemoglobin ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelets ≥80×109/L; AST and ALT ≤ 1.5 ULN or ≤ 3 ULN for subjects with liver metastases; Total bilirubin ≤1.5 ULN; Serum creatinine ≤1.5 ULN or measured or calculated creatinine clearance > 50ml/min; Albumin ≥ 30g/L;

  9. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication and must be willing to use an adequate method of contraception for the course of the study through 90 days after the last dose of study medication. Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy

Exclusion Criteria:

  1. Patients have recovered adverse events associated with pretreatment to Grade 1 or lower with CTCAE v5.0 excluding alopecia
  2. Patients have an active malignancy (except for definitively treated basal cell carcinoma of the skin, or carcinoma-in-situ of the cervix) within the past 5 years
  3. Patients with uncontrolled central nervous system metastasis
  4. Received anti-tumor therapy within 4 weeks, including: chemotherapy (the washout period of oral fluorouracil drugs is 2 weeks), targeted therapy (the washout period of small molecule targeted drugs is 2 weeks or 5 half-lives, whichever is shorter), immunotherapy, etc.;
  5. Received radical radiotherapy (including >25% bone marrow radiotherapy) and brain radiotherapy within 4 weeks; brachytherapy (such as implantation of radioactive particles) within 60 days; received palliative radiotherapy for bone metastases within 1 week;
  6. Patients with a history of prior treatment with docetaxel, paclitaxel, nab-paclitaxel or bevacizumab
  7. Received surgery within 4 weeks or unhealed wounds, Ulcers, fractures;
  8. Uncontrollable malignant pleural effusion, ascites, or pericardial effusion (defined as the investigator's judgment cannot be effectively controlled by diuretics or puncture);
  9. Patients have gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors, or other conditions judged that may cause gastrointestinal bleeding or perforation;
  10. Patients with evidence or medical history of thrombosis or obvious bleeding tendency within 2 months (bleeding> 30 mL within 2 months, hematemesis, melena, blood in the stool), hemoptysis (> 5 mL of fresh blood within 4 weeks);
  11. Patients have arterial thrombosis or deep vein thrombosis occurred within 6 months; or stroke and/or transient ischemic attack occurred within 12 months;
  12. Active heart disease that is not well controlled, e.g. symptomatic coronary heart disease, New York Heart Association (NYHA) congestive heart failure of grade II or above, severe arrhythmias requiring drug intervention, myocardial infarction within the past 6 months, LVEF<50%
  13. Patients judged with clinically significant electrolyte abnormalities
  14. Patients have an active infection or an unexplained fever (temperature> 38.5℃) during the screening period or before the first administration
  15. Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year
  16. Is pregnant or breastfeeding
  17. Patients were judged unsuitable as subjects of this trial by investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nab-paclitaxel Combined With Bevacizumab
Nab-paclitaxel, Bevacizumab
Drug: Nab-paclitaxel Combined With Bevacizumab
Nab-paclitaxel 150mg/m2 ，iv drip, d1, Bevacizumab 5mg/kg, iv drip, d1, q2w.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: an expected average of 24 months
Duration from the date of initial treatment to the date of death due to any cause
an expected average of 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Duration of Response (DoR)
Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
The percentage of patients who achieve complete remission(CR) or partial remission (PR) or stable disease(SD) determined by the RECIST v1.1 criteria.
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Progression Free Survival (PFS)
Time Frame: an expected average of 24 months
A duration from the date of initial treatment to radiographic disease progression or death of any cause
an expected average of 24 months
Disease Control Rate (DCR)
Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Proportion of objective complete response, partial response and stable patients
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Adverse events
Time Frame: an expected average of 24 months
Including other occasional or rare AEs
an expected average of 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Collaborators

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2021

Primary Completion (Anticipated)

January 5, 2022

Study Completion (Anticipated)

January 5, 2024

Study Registration Dates

First Submitted

January 6, 2021

First Submitted That Met QC Criteria

January 9, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 9, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGOG3006/NEC-BEVAX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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