Pancreatic Cancer Clinical Trial
Official title:
K-001 Treatment of Advanced Pancreatic Cancer: Phase I 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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
NCT04927780 -
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
|
Phase 3 | |
| Recruiting |
NCT06054984 -
TCR-T Cells in the Treatment of Advanced Pancreatic Cancer
|
Early Phase 1 | |
| 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 | |
| Recruiting |
NCT04183478 -
The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer
|
Phase 2/Phase 3 | |
| 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
|