Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04183478
Other study ID # CPOG001-05
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date September 26, 2017
Est. completion date March 2021

Study information

Verified date November 2020
Source RenJi Hospital
Contact Jiujie Cui, MD
Phone 86-21-68385559
Email cuijiujie@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

No Standard therapy has been approved for third-line therapy of advanced pancreatic cancer. K001 is peptidoglycan prepared from the marine microorganism, with an anti-tumor activity. Previously, the phase I study of K001 has shown that K001 was safety and had some effectiveness for pancreatic patients. Now, we would like to lunch a randomized, blinded, parallel-controlled, multi-center phase II/III study to compare the best support care (BSC) plus K-001 versus BSC plus placebo for the third-line and later treatment of patients with advanced pancreatic cancer.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date March 2021
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Older than 18 years. 2. Metastatic or locally advanced pancreatic ductal adenocarcinoma which is confirmed by primary and/or metastatic pathology/cytology examination. 3. Had received at least 2 lines chemotherapy regimen, and the disease is progression or the toxicity could not be tolerated. 4. At least 28 days after the last chemotherapy. 5. Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1). 6. Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2. 7. Adequate hepatic, renal, and hematologic functions (neutrophils =1.5×10^9/L, platelets = 80×10^9/L,hemoglobin =90g/L, total bilirubin within 2.0×the upper limit of normal(ULN), albumin=30g/L, and ALT and AST=3×the ULN (If liver metastases, serum transaminase=5×the ULN), serum creatine = 1.5 x ULN and creatinine clearance rate > 30ml/min (Cockcroft-Gault). 8. For women of child-bearing age, the pregnancy test results (serum or urine) within 14 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 60 days post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 60 days post the last administration of study drug. 9. Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure Exclusion Criteria: 1. Patients is not confirmed by pathology/cytology examination as pancreatic ductal adenocarcinoma. 2. Target lesions were once treated locally and does not exhibit progression recently. 3. Patients with already diagnosed central nervous system metastasis. Patients with clinical symptoms of central nervous system metastasis should be examined by MRI. 4. Patients with Vater 's ampullary carcinoma or biliary adenocarcinoma. 5. Subject with partial or complete intestinal obstruction,or complete biliary obstruction who are unable to be relieved by active treatment 6. Subject has more than an average of intra-abdominal effusion, or the intra-abdominal effusion could not be control in 2 weeks. 7. Subject has a second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers treated with curative intent and no known active disease within 5 years before planned start of study therapy. 8. Female subjects who are pregnant, planning a pregnancy or breast feeding during the study. 9. Subject has an active infection, or a hypertension could not be controlled by drugs, or angina diagnosed within 3 months, or unstable angina pectoris, or myocardial infarction diagnosed within 1 year, or with congestive heart failure (New York Heart Association [NYHA] Class II or III or IV), or with schizophrenia, or with the history of psychotropic substance abuse. 10. Subject has an active infection of hepatitis B (HBV), hepatitis C (HCV) or human immunodeficiency virus (HIV). 11. Subject has received any of the following treatment within the framework of a specific time frame prior to entry: 1. received operation greater than grade II within 4 weeks; 2. received extended range radiotherapy within 4 weeks, or locally radiotherapy within 2 weeks; 3. participated in other therapeutic/interventional clinical trials within 4 weeks; 4. received locally anti-tumor therapy within 4 weeks; 12. All toxic effects of any prior antitumor therapy resolved to Grade < 2 before the start of study therapy (with the exception of alopecia and pigmentation of skin). 13. Subject has known to be allergic or intolerant to K-001 and its excipients. 14. Other situations that the researchers considered inappropriate for inclusion in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
K-001
K-001 is an antitumor active substance (peptidoglycan) which is prepared from the fermentation product of marine microorganism. K-001 is the Chinese first class new drug and get patent licensing in China, America and Japan.
Other:
placebo
Placebo which looks the same as K-001 in apparence

Locations

Country Name City State
China RenJiH Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Tumor marker blood test to evaluate change of tumor markers, including CEA, CA19-9, CA125, CA724, AFP and etc. of the two groups 6 months after the last subject is enrolled
Other Hematology Index blood test to evaluate change of D-Dimer, C-Reactive protein (CRP), Albumin (ALB), CAR (CRP/ALB) of the two groups 6 months after the last subject is enrolled
Primary overall survival The overall survival (OS) of the two groups of FAS was compared. FAS including all the subjects who take at least one dose of the research drug. All the subjects received tumor assessment every 8weeks according to RECIST1.1. 6 months after the last subject is enrolled
Secondary PFS All the subjects received tumor assessment every 8weeks according to RECIST1.1 to evaluate the progression-free survival (PFS) . 6 months after the last subject is enrolled
Secondary TTP All the subjects received tumor assessment every 8weeks according to RECIST1.1 to evaluate the time to progression (TTP). 6 months after the last subject is enrolled
Secondary ORR All the subjects received tumor assessment every 8weeks according to RECIST1.1 to evaluate the objective response rate (ORR). 6 months after the last subject is enrolled
Secondary DCR All the subjects received tumor assessment every 8weeks according to RECIST1.1 to evaluate the disease control rate (DCR). 6 months after the last subject is enrolled
Secondary CBR According to a questionaire to evaluate the clinical benefit response (CBR) of the two groups. 6 months after the last subject is enrolled
Secondary QOL According to a questionaire to evaluate the quality of life (QOL) of the two groups. 6 months after the last subject is enrolled
See also
  Status Clinical Trial Phase
Completed NCT05305001 - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Recruiting NCT06054984 - TCR-T Cells in the Treatment of Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT04927780 - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer Phase 3
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Terminated NCT03140670 - Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy Phase 2
Terminated NCT00529113 - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Phase 1
Recruiting NCT05168527 - The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05391126 - GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care N/A
Terminated NCT03300921 - A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer Phase 1
Completed NCT03153410 - Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas Early Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT05679583 - Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer Phase 2
Terminated NCT03600623 - Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Completed NCT04290364 - Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2