Archives: Clinical Trials

With the development of pancreatic surgery, the surgeon has put more emphasis on chylous fistula as the postoperative complications in recent years. The diagnostic criteria and treatment methods about chylous leakage have been developed and improved in clinical practice. However, there remains controversy about the high risk factors and efficient control measures during the perioperative period.

Study of neoadjuvant paricalcitol to target the microenvironment in resectable pancreatic cancer to determine the effect of targeting the vitamin D metabolic program in the tumors of patients treated with one cycle of gemcitabine/abraxane with or without paricalcitol prior to surgery for resectable pancreatic cancer.

This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.

This is an open-label, multi-center, phase 1b study designed to determine a tolerable dose of CX-5461 administered by IV infusion on Day 1 and Day 8 of a 28-day cycle in patients with selected solid tumours and associated mutations for future Phase II trials. The safety and tolerability of CX-5461, preliminary evidence of antitumor effect and the effect of CX-5461 on the Health-Related Quality of Life (HRQoL) will also be evaluated. The study will also evaluate the predictive value of mutational signatures and explore the significance of dynamic changes in ctDNA levels and plasma DNA methylome profiling in this study's exploratory cohort.

The goal of this study is to learn if the genetic information and proteins from tumours can help treat pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are:

* Is it feasible to obtain genetic test results within a timeframe that can help inform treatment decisions for individuals with PDAC?
* Can the genetic test results provide information about how a tumour will respond to or resist treatment?

Participants will:

* Receive standard chemotherapy to treat their cancer.
* Provide samples of their blood, tissue, and fluid for genetic testing.
* Visit the clinic every 4 weeks for check-ups and tests.
* Complete questionnaires every 12 weeks.

A first-in-human open-label, Phase I/II study to evaluate the safety, tolerability, MTD/RP2D, PK, and preliminary efficacy of AST-001 administered as a single agent.

Single-agent gemcitabine is currently still regarded as one international standard of care for patients with advanced pancreatic cancer (Burris 1997 [4]). The oral EGFR tyrosine kinase inhibitor erlotinib received EMEA-approval for the treatment of patients with metastatic pancreatic cancer in January 2007.

In the pivotal phase III trial, the combination of gemcitabine plus erlotinib was associated with a statistically significant prolongation of OS (compared to single-agent gemcitabine), however, the absolute survival benefit was – for the overall study population – clinically moderate (median OS: 6.24 vs 5.91 months, 1-year OS rate: 23% vs 17%; HR = 0.82, p=0.038) (Moore 2007 [19]).

The recently presented FOLFIRINOX regimen shows enhanced activity in metastatic pancreatic cancer patients. This regimen is, however, limited to patients with good performance status (ECOG 0-1), no major comorbidity, age <75 years, and bilirubin <1.5 ULN (Conroy 2011 [6]). The majority of pancreatic cancer patients will therefore not be treated with this regimen.

Accordingly, novel treatment concepts are urgently needed in pancreatic cancer and pre-clinical data indicate an important role of the EGFR1/erbB2 receptor signalling in the pathogenesis of pancreatic adenocarcinoma (Yeh 2007 [24]). A recent publication (Larbouret 2010 [16]) indicates that the combination of cetuximab and trastuzumab induced superior antitumour activity in human pancreatic carcinoma xenografts compared to gemcitabine alone (see also Larbouret 2007 [15]). Furthermore, synergistic antitumour activity was observed when monoclonal antibodies directed against the EGFR1 and erbB2 were combined (Ben-Kasus 2009 [3]). Based on these data, there is a good rationale to further investigate the combined inhibition of the erbB family in pancreatic cancer patients.

Afatinib (BIBW 2992) is a novel irreversible EGFR1- and HER2 and HER4 inhibitor that is applied orally. The purpose of the present trial is to investigate the erbB family inhibition by afatinib in patients with metastatic pancreatic cancer.

In the planned trial, afatinib will be applied at the dose (40 mg/day) that was chosen for the randomised phase III trial (LUX 5 study) that investigates afatinib plus weekly paclitaxel (80mg/m2).

Presently there is also a phase I study ongoing that investigates the combination of afatinib with gemcitabine (ClinicalTrials.gov Identifier: NCT01251653 U10-2249-02 ). Possibly the data will be available once the study is ready to start. Otherwise a modification of the regimen will be planned once the respective data will be available.

In this trial, we integrate a translational project which may allow the identification of patients that primarily benefit from this novel treatment approach. The availability of tumour tissue- and blood samples from each patient is therefore an important inclusion criterion.

A 2:1 randomisation is chosen favouring the experimental arm since a large body of data is available on gemcitabine alone and since sufficient efficacy and toxicity data shall be gained in the experimental arm. In addition, the patients&apos; motivation to take part in the trial will be greatly enhanced by a greater chance to receive the experimental agent.

The purpose of the Phase 1/2a study is to evaluate the safety and tolerability of SNK01 in combination with trastuzumab or cetuximab in order to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the preliminary efficacy for each combination regimen.

This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.

This randomized phase II trial studies how well combination chemotherapy (mFOLFIRINOX) with or without hypofractionated radiation therapy before surgery works in patients with pancreatic cancer that can be removed by surgery. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. It is not yet known if combination chemotherapy is more effective with or without hypofractionated radiation therapy before surgery in treating patients with pancreatic cancer.