NCT02469883

Brief Summary

This study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of Sinotecean.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

1.4 years

First QC Date

March 22, 2015

Last Update Submit

June 9, 2015

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetic Assessments for Area Under Curve（AUC）

    To collect point with single drug:5 min/10 min/15 min/30 min/1 h/2h/4h/6 h/8h/10h/12 h/24 h/32h/48 h

    Day 1-2 Single Dose

  • Pharmacokinetic Assessments for Cmax

    Day 1-2 Single Dose

  • Pharmacokinetic Assessments for Tmax

    Day 1-2 Single Dose

Secondary Outcomes (3)

  • Objective Response Rate （ORR)

    each 42 days up to intolerance the toxicity or progression of disease（PD） (up to 24 months)

  • Maximum tolerated dose(MTD)

    up to 24 months

  • Dose-limiting toxicity(DLT)

    up to 24 months

Study Arms (1)

Sinotecean

EXPERIMENTAL
Drug: Sinotecean

Interventions

SinoteceanDRUG
Sinotecean

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • late malignant tumor patients diagnosed with the pathological and/or cytological;
  • lack of the standard treatment or treatment failure;
  • years, ECOG:0-1,expected survival period \>3 months;
  • main organs function is normal;
  • signed and dated informed consent

You may not qualify if:

  • participated in other clinical trials in four weeks;
  • currently under other effective treatment;
  • end of anti-tumor treatment within 4 weeks(end of Nitrosourea/Mitomycin within 6 weeks);
  • AE ≥ Grade 2(according to NCI-CTC 4.0),except hair loss;
  • with ischemic heart disease, heart failure, severe arrhythmia, cerebrovascular disease, asthma, severe infections, active peptic ulcer;
  • urine protein: ++, and urinary in 24 hours \> 1.0g;
  • uncontrolled primary or metastatic brain;
  • have immunodeficiency history;
  • according to the researcher's judgment,there are concomitant diseases which will seriously endanger the patients or obstruct the patients to complete the clinical trial;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Central Study Contacts

Shusen Wang, doctor

CONTACT

wangshs@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2015

First Posted

June 12, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

CN(1)