K-001 Treatment Of Advanced Pancreatic Cancer: Clinical Trial Of Monotherapy's Tolerability

Study Overview

K-001 Treatment of Advanced Pancreatic Cancer: Clinical Trial of Monotherapy's Tolerability

This study is an open and single-center Phase I clinical research on patients with advanced pancreatic cancer, for evaluating their adverse reactions or tolerance to K-001, so as to determine the safe and reasonable dosage and dosing regimen.

According to past experience to toxicology studies and clinical test, K-001 at a dose of 2700mg/day has a good safety profile for human body. Upon observation, pancreatic cancer patients receiving a medication at 2160mg/day (1080mg BID) have had good therapeutic efficacy, no sign of significant toxicity. Dosing regimen: Phase I clinical test: maximum dose of monotherapy at 2700mg/day. Four groups of repeated administration of monotherapy, at least 3 patients for each group. Group A: 2700mg/d (1350mg BID); Group B: 3240mg/d (1620mg BID); Group C: 3780mg/d (1890mg BID); Group D: 4320mg/d (2160mg BID). Twice a day, to be taken with warm water on an empty stomach; 4 weeks' administration for each group. In case of severe adverse reactions associated with the test drug, or if half of the participants show adverse reactions at Ⅲ level and above, the test should be terminated. The maximum dosage not causing the above-described situation shall be considered as the maximum tolerated dose or the biologically effective dose. After the test, continuous medication shall be given upon request from patients.

Pancreatic Cancer

DRUG: K-001

CPOG001_01

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-02-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-01-05
First Submitted that Met QC Criteria 2016-03-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2017-01-06
First Posted (ESTIMATED) 2016-03-28	Results First Posted N/A	Last Verified 2017-01

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Group A:K-001 2700mg/d (1350mg BID) K-001 1350mg twice a day, to be taken with warm water on an empty stomach; 4 weeks' administration for each group.	DRUG: K-001 In case of severe adverse reactions associated with the test drug, or if half of the participants show adverse reactions at Ⅲ level and above, the test should be terminated. The maximum dosage not causing the above-described situation shall be considered
EXPERIMENTAL: Group B: K-001 3240mg/d (1620mg BID) K-001 1620mg twice a day, to be taken with warm water on an empty stomach; 4 weeks' administration for each group.	DRUG: K-001 In case of severe adverse reactions associated with the test drug, or if half of the participants show adverse reactions at Ⅲ level and above, the test should be terminated. The maximum dosage not causing the above-described situation shall be considered
EXPERIMENTAL: Group C: K-001 3780mg/d (1890mg BID) K-001 1890mg twice a day, to be taken with warm water on an empty stomach; 4 weeks' administration for each group.	DRUG: K-001 In case of severe adverse reactions associated with the test drug, or if half of the participants show adverse reactions at Ⅲ level and above, the test should be terminated. The maximum dosage not causing the above-described situation shall be considered
EXPERIMENTAL: Group D: K-001 4320mg/d (2160mg BID) K-001 2160mg twice a day, to be taken with warm water on an empty stomach; 4 weeks' administration for each group.	DRUG: K-001 In case of severe adverse reactions associated with the test drug, or if half of the participants show adverse reactions at Ⅲ level and above, the test should be terminated. The maximum dosage not causing the above-described situation shall be considered

Primary Outcome Measures	Measure Description	Time Frame
The maximum-tolerated dose (MTD) of K-001	The maximum-tolerated dose (MTD) of K-001 will be defined as the maximum dose level at which no more than one patient out of three experiences a dose-limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) criteria, version 4.0. If none of the patient experiences DLT, the maximum dose in the trial (4320mg/d) will be defined as MTD and the biologically effective dose.	day 29

Secondary Outcome Measures	Measure Description	Time Frame
Change of life quality assessed using EORTC QLQ-C30 V 3.0	EORTC QLQ-C30 V 3.0	within 7 days before taking drugs and day 8, day 15, day 22 and day 29
Change from Baseline of the Treg cell count	Laboratory tests: blood immunity test of FOXP3+CD4+Treg cell count	within 14 days before taking drugs, day 15 and day 29
Evaluation of suffered pains assessed using Numerical Rating Scale (NRS)	Numerical Rating Scale (NRS)	within 7 days before taking drugs and day 8, day 15, day 22 and day 29
Change from Baseline of the C-reactive protein (CRP)	Evaluation the level of CRP with laboratory tests of blood.	within 14 days before taking drugs, day 15 and day 29
Clinical efficacy of K-001 assessed by disease control rate (DCR) according to RECIST V 1.0 criteria	Evaluate patients with imaging, including CT/MRI of the chest, abdomen and pelvic, and get disease control rate (DCR) according to RECIST V 1.0 criteria.	day 29

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Absolute neutrophil count: ≥1.5×109/L;
Platelet count: ≥80×109/L;
Hemoglobin: ≥9.0 g/dL. 9. Total bilirubin: ≤1.5 x ULN, albumin: ≥3.0g/dL; 10. Patients without liver metastasis: ALT (SGPT) & AST (SGOT) ≤3.0 x ULN Patients with liver metastasis: ALT (SGPT) & AST (SGOT)≤5.0 x ULN; 11. Renal functions: serum creatinine ≤ 1.5xULN, Ccr ≥ 60ml/min (Cockcroft-Gault);

A consecutive 5-year disease-free survival from single surgery of other malignancies;
Cured basal cell carcinoma and cured cervical carcinoma in situ.

Having had a major surgery within 4 weeks before inclusion;
Having received expanded scope of radiotherapy within 4 weeks, or having received limited scope of radiotherapy within 2 weeks before inclusion;
Having participated in any other therapeutic/interventive clinical trials within 4 weeks before inclusion, or taking part in an ongoing trial. 11. With CTCAE toxicity at level II or above (excluding hair loss or skin pigmentation), uncured and caused by any previous treatment; 12. Not fitting in the study, as conceived by the researcher.

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: Xingpeng Wang, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Cui J, Yang H, Liu J, Chen D, Hu J, Zhang H, Wang Y, Han T, Mao T, Jiao F, Biskup E, Pan Y, Liu M, Wang L. A phase I study of the safety and activity of K-001 in patients with advanced pancreatic ductal adenocarcinoma. BMC Cancer. 2021 Jun 7;21(1):672. doi: 10.1186/s12885-021-08375-6.

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