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

NCT02720666 | Completed Phase 1 DMC

• 1 other identifier: CPOG001_01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change of life quality assessed using 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

  within 14 days before taking drugs, day 15 and day 29

• Evaluation of suffered pains assessed using 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)

  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

  day 29

Study Arms (4)

Group A:K-001 2700mg/d (1350mg BID)

EXPERIMENTAL

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

Group B: K-001 3240mg/d (1620mg BID)

EXPERIMENTAL

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

Group C: K-001 3780mg/d (1890mg BID)

EXPERIMENTAL

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

Group D: K-001 4320mg/d (2160mg BID)

EXPERIMENTAL

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

Interventions

K-001 DRUG

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.

Also known as: Peptidoglycan Complex of Spirulina

Group A:K-001 2700mg/d (1350mg BID); Group B: K-001 3240mg/d (1620mg BID); Group C: K-001 3780mg/d (1890mg BID); Group D: K-001 4320mg/d (2160mg BID)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Based on histodiagnosis or cytodiagnosis;
• Locally advanced or metastatic pancreatic adenocarcinoma;
• Failure of standard treatment, \>28 days after the last chemotherapy;
• Patients not suitable for or having given up standard treatment;
• At least one lesion measurable according to RECIST V 1.0 criteria;
• ECOG score: 0～1;
• Expected survival: ≥3 months;
• Haematological, biochemical and organ functions:
• Hematological indices:
• Absolute neutrophil count: ≥1.5×109/L;
• Platelet count: ≥80×109/L;
• Hemoglobin: ≥9.0 g/dL.
• Total bilirubin: ≤1.5 x ULN, albumin: ≥3.0g/dL;
• Patients without liver metastasis: ALT (SGPT) \& AST (SGOT) ≤3.0 x ULN Patients with liver metastasis: ALT (SGPT) \& AST (SGOT)≤5.0 x ULN;
• Renal functions: serum creatinine ≤ 1.5xULN, Ccr ≥ 60ml/min (Cockcroft-Gault);

You may not qualify if:

• Patients of pancreatic tumor but not adenocarcinoma;
• Having received radiotherapy for his/her target lesions prior to this study, with no progress;
• Known presence of brain metastases or leptomeningeal metastases;
• With Vater's ampulla cancer or bile duct cancer;
• Partial or complete intestinal obstruction;
• History of other malignancies in past five years, except for:
• A consecutive 5-year disease-free survival from single surgery of other malignancies;
• Cured basal cell carcinoma and cured cervical carcinoma in situ.
• Pregnant or breast-feeding women;
• Any unstable systemic disease, including: active infection; hypertension uncontrollable by medication (≥160/100mmHg); unstable angina, or angina with the onset from within the last three months; congestive heart failure (≥level II according to New York Heart Association \[NYHA\], see Annex 4); myocardial infarction occurred within 1 year before the enrollment; severe arrhythmias requiring medical treatment; and mental disorders, etc.;
• Presence of active hepatitis B (history of hepatitis B infection, whether with or without medication, HBV DNA≥104 copy number or ≥2000u/ml) or HCV-Ab positive; known HIV-positive patients (no clinical signs or symptoms suggesting exemption of HIV test for HIV-infected individuals);
• With CTCAE toxicity at level II or above (excluding hair loss or skin pigmentation), uncured and caused by any previous treatment;
• Not fitting in the study, as conceived by the researcher.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (1)

• 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.

  PMID: 34098895 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Xingpeng Wang, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2016
• First Posted: March 28, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 6, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)