Anlotinib Combined With Platinum/Gemcitabine for First Line Treatment of Advanced Urothelial Carcinoma

August 30, 2021 updated by: Tianjin Medical University Second Hospital

A Single-arm, Phase II Study of Anlotinib Combined With Platinum/Gemcitabine for First Line Treatment of Advanced Urothelial Carcinoma

Anlotinib is a novel oral multitarget tyrosine kinase inhibitor and primary targeted to VEGFR, FGFR, PDGFR and c-Kit. This study intends to assess the efficacy and safety of anlotinib combined with platinum/gemcitabine for first line treatment of advanced urothelial carcinoma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to determine the antitumor activity of anlotinib combined with platinum/gemcitabine (Objective Response rate, ORR) in patients with advanced urothelial carcinoma.

Study Type

Interventional

Enrollment (Anticipated)

53

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 Contact

Study Contact Backup

Study Locations

  • China
      • Tianjin, China, 300211
        • Tianjin Medical Unversity Second Hospital
        • Contact:

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18-75 years, ECOG PS: 0-1.
  2. Unresectable or metastatic urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
  3. At least one measurable lesion according to RECIST 1.1.

  4. The main organ function meets the following criteria within 7 days before enrollment:

    1. Blood tests are subject to the following criteria (without blood transfusion within 14 days): hemoglobin (HB) ≥ 90g / L; neutrophil absolute value (ANC) ≥ 1.5 × 109 / L; platelets (PLT) ≥ 80 × 109 / L.
    2. Biochemical tests are subject to the following criteria: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5ULN, such as with liver metastasis, then ALT and AST ≤ 5ULN; serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min.
  5. Women of childbearing age must have taken reliable contraceptive measures and performed a pregnancy test (serum) within 3 days prior to enrollment, and the results were negative, and were willing to use appropriate methods during the trial and 180 days after the last administration of the test drug.
  6. Patients voluntarily joined the study and signed informed consent, with good adherence and follow-up.

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. A history of hypersensitivity to the study drugs.
  3. Patients have received systemic treatment.
  4. Patients with uncontrolled or high-load central nervous system metastases (or with obvious symptoms)

  5. Patients with other diseases, including:

    1. Hypertension and uncontrollable levels of normal anti-hypertensive medication: systolic blood pressure≥150 mmHg, diastolic blood pressure≥90 mmHg.
    2. Unstable angina, newly diagnosed with angina or acute myocardial infarction within 6 months prior to enrollment, arrhythmia ( including: QTcF of male≥450ms ) requires medical intervention congestive heart failure (New York Heart Association (NYHA)≥2)
    3. Active or uncontrollable infections (CTCAE 5.0≥2)
    4. Known history of human immunodeficiency virus infection (HIV, congenital immune deficiency disease, or a history of organ transplantation)
    5. Urinary protein ≥ ++ or 24 hours urine protein > 1 g
    6. Any malignant tumor within 5 years, except those who have been cured or stabilized.
    7. Uncured adverse events (NCI-CTCAE 5.0 grade II or greater) due to any treatment before, except for alopecia.
    8. There are many factors that affect oral drug absorption (such as inability to swallow, Postgastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.).
    9. Abnormal blood coagulation (PT>16s、APTT>43s、TT>21s、Fbg<2g/L), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy. Under the premise of an odds ratio (INR) ≤ 1.5, low-dose heparin (1mg daily) or low-dose aspirin (daily dose ≤ 100 mg) is allowed for preventive purposes.
    10. Patients who underwent major surgical treatment, open biopsy, or significant traumatic injury within the first 4 weeks of enrollment.
    11. Patients whose tumor has radiographically invaded an important vessel or whose tumor is determined by the investigators to be at high risk of incurring an important vessel and causing fatal hemorrhages during the study period.
    12. Patients who have seizures and need treatment.
    13. Patients with any signs of hemorrhage or history, regardless of severity; patients with any bleeding or bleeding episodes (NCI-CTCAE 5.0 grade III) within 4 weeks prior to grouping have unhealed wounds, ulcers, or fractures.
    14. Artery or venous thrombosis occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism.
    15. Patients have been inoculated with attenuated live vaccine within 28 days before enrollment or plan to inoculate vaccine during the trial.
    16. Other systemic diseases that can't be controlled (such as diabetes, etc.).
  6. Patients with other serious physical or mental illness or laboratory abnormalities that may increase the risk of participating in the study or interfere with the results of the study, as well as patients that the investigator considers unfit to participate in the study.
  7. Patients who have participated in clinical trials of other antitumor drugs within four weeks.

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From date of enrollment until disease progression,assessed up to 1 year
The objective response rate is defined as the percentage of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1(RECIST v1.1) criteria. Per RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
From date of enrollment until disease progression,assessed up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DoR)
Time Frame: From date of enrollment until disease progression,assessed up to 3 years
The duration of response (CR or PR) is defined as the earliest date a participant achieved a CR or a PR, calculated from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.
From date of enrollment until disease progression,assessed up to 3 years
Progression free survival (PFS)
Time Frame: From date of enrollment until the date of first documented progression,assessed up to 3 years
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
From date of enrollment until the date of first documented progression,assessed up to 3 years
Overall Survival (OS)
Time Frame: From date of enrollment until death,assessed up to 5 years
Overall survival is defined as the time interval in days between the date of the first dose of study drug and the participant's death from any cause.
From date of enrollment until death,assessed up to 5 years

Collaborators and Investigators

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

Sponsor

Tianjin Medical University Second Hospital

Investigators

  • Principal Investigator: Yuanjie Niu, MD,PhD, Tianjin Medical Unversity Second Hospital

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 (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTER-UC-008

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.

Clinical Trials on Urogenital Neoplasms

Clinical Trials on Gemcitabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe