Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Neoplasm Metastasis

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Antimetabolites

Subjects receive Gemcitabine 1000 mg/m2 weekly intravenous infusion.

Part A: Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, subjects received Gemcitabine 1000 mg/m2 weekly intravenous infusion.

Part B: Subjects received the PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.

Part A: Closed to enrollment.Part B: Approximately 20 patients will be randomized to the control arm that will receive a standard regimen of gemcitabine and 20 patients will be randomized to the PCI-27483 arm and treated with both gemcitabine and PCI-27483. PCI-27483 will be administered as subcutaneous (SC) injections, nominally at a dosage of 1.2 mg/kg BID. Patients receiving PCI-27483 with a tumor response or stable disease at 12 weeks will have the option to continue PCI-27483 treatment until disease progression or the investigator considers the study treatment no longer tolerable. Treatment with gemcitabine may continue per standard of care.

All evaluable patients will roll over into Part C at week 16 (Day 113±5). If 2 consecutive INRs at 2 hours postdose are \>3.50,a reduced dosage will be calculated.

PCI-27483

Eric Hedrick, MD

Laurence Elias, MD

The purpose of this study is to evaluate the safety and tolerability of selected dose 1.2mg/kg BID dosage administered subcutaneously (SC) administered PCI-27483 to metastatic or locally advanced pancreatic cancer patients receiving concurrent therapy with intravenously administered gemcitabine for 12 weeks.

This study will be conducted in three segments: Part A, Part B and Part C. Parts A and B are 12 weeks of treatment followed by 4 weeks of evaluation. In part A patients will dose-escalate up to three dose levels of PCI-27483 administered as subcutaneous (SC) injections twice-daily (BID). Part B to start once 4th patient completes 90 of 112 doses in 8 weeks. In part B patients are randomized to PCI-27483 and gemcitabine (active arm) OR gemcitabine only (control arm). PCI-27483 doses in both Part A and B will be administered in combination with a standard regimen of gemcitabine. Patients with a tumor response or stable disease at 12 weeks will have the opportunity to continue PCI-27483 treatment until disease progression or the Investigator considers the study treatment to be no longer tolerable. Treatment with gemcitabine in either the active or control arm may continue until a standard course of gemcitabine therapy has been completed. Patients will complete Part A or Part B after 16 weeks on study regardless of treatment duration. Evaluable patients will roll over into part C and be followed for 12 months from enrollment (first dose).

Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine

Phase II Study of Coagulation Factor VIIa Inhibitor PCI-27483 in Pancreatic Cancer Patients Receiving Treatment With Gemcitabine

Clinically meaningful toxicity adverse events will be defined in accordance with by CTCAE v3.0

Pharmacyclics LLC.

Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, patients received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.

All treated subjects in this group experienced at least one "treatment-emergent" adverse event.

(PCI-27483 + Gemcitabine)/Part A

Part B is a randomized arm to evaluate safety and efficacy. Patients received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.

All treated subjects in this group experienced at least one "treatment-emergent" adverse event.

(PCI-27483 + Gemcitabine)/Part B

Patients in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.

All treated subjects in this group experienced at least one "treatment-emergent" adverse event.

Gemcitabine/Part B

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Dr. Laurence Elias

Number of Participants With Treatment Emergent Adverse Events (AEs)

Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, subjects received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.

PCI-27483 + Gemcitabine/Part A

Part B is a randomized arm to evaluate safety and efficacy. Subjects received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.

PCI-27483 + Gemcitabine/Part B

Subjects in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.

Overall Study

Philippe CASSIER

Philippe CASSIER, MD

PATAKESS is a monocentric non interventional cohort study (prospective (alive patients) and retrospective (dead patients with biological material from surgery and/or biopsies already collected)).

PATAKESS consists of clinical and biological analyses of exocrine pancreatic tumors. Data are derived from tumor samples taken for routine health care purposes in patients managed at Centre Léon Bérard (Lyon-France) since January 2010. The main objective is to determine correlation between biological and clinical characterizations of patients suffering from exocrine pancreatic tumor.

Pancreatic adenocarcinoma cancer is an aggressive cancer which represents 95% of pancreatic cancer. Pancreatic adenocarcinoma cancer is one of the deadliest cancers (5th cause of death per cancer) ; it has a very poor prognosis: 5-year survival (regardless of all stades at diagnosis). Pancreatic adenocarcinoma cancer is characterized by early metastasis. Therefore, development of efficient systemic therapeutics is one of the keys to improving prognosis. Newly developed immune check-point inhibitors seem to have limited efficacy in pancreatic adenocarcinoma except for MSI-H (Microsatellite instability-high) or dMMR (mismatch repair deficient)/MSI-H tumors.

However, recent data suggest that immune surveillance could control metastatic dissemination of pancreatic adenocarcinoma cancer. Several studies showed strong interactions between pancreatic tumor cells and tumor stroma in metastatic dissemination and in resistance to conventional therapeutics. Many data about pancreatic primitive tumors from murine animals models are available ; however few data on tumor stroma and its interactions with tumor cells of metastasis from adenocarcinoma pancreas are available. Few data on correlation between molecular alterations types (mutations, deletions, amplifications) in pancreatic adenocarcinoma cells and tumor stroma characteristics (primitive and metastatic stroma (cells composition, immune infiltration)) are also available.

In PATAKESS study, clinical and biological data are derived from tumor samples taken for routine health care purposes in patients managed at Centre Léon Bérard (Lyon-France) since January 2010.

Exocrine pancreatic tumor samples (from initial diagnosis biopsy and/or from surgery specimen of primitive tumor and/or from metastases) and blood sample (collected during a routine check-up)

PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors

Clinical characteristics of patients are consistent with tumor response at each treatment line and disease stage at diagnosis ; Biological characteristics will describe molecular alterations of the tumor by sequencing techniques like Next Generation Sequencing (NGS)

Comparative characterization of the different stroma by immunological detection

Comparative characterization of the different stroma by NGS

Centre Leon Berard

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Colorectal Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplasms, Squamous Cell

Pembrolizumab

Carboplatin

Cisplatin

Tisotumab vedotin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Tisotumab Vedotin on Day 1 of every 21-day cycle in participants with various solid tumors in 2L+

Tisotumab Vedotin on Days 1, 8, and 15 of 28-day cycle in participants with various solid tumors in 2L+

Tisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with HNSCC or sqNSCLC in 2L+

Tisotumab Vedotin + pembrolizumab + (carboplatin or cisplatin). Given on Day 1 of every 21-day cycle in participants with various solid tumors in 1L HNSCC or sqNSCLC

Tisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with HNSCC in the second- or third-line setting

Tisotumab Vedotin + pembrolizumab. Tisotumab Vedotin given on Days 1, 15, and 29 of every 6-week cycle. Pembrolizumab given on Day 1 of every 6-week cycle in participants with HNSCC in the first line setting

Tisotumab Vedotin + pembrolizumab + carboplatin. Tisotumab Vedotin and carboplatin given on Days 1, 15, and 29 of every 6-week cycle. Pembrolizumab given on Day 1 of every 6-week cycle in participants with HNSCC in the first line setting

tisotumab vedotin

pembrolizumab

AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IV

carboplatin

cisplatin

Seagen Trial Information Support

Assuntina Gesualda Sacco, MD

Brenda Hann

Heather Wakelee, M.D.

Jennifer Saller

Steven R Schuster

Daniela Skiff

Thomas George

Alaa Taha

Christine Chung

Briana Porwisz

Jochen Lorch, MD

Ari Rosenberg, MD

Cindy Stoner

Bert H O'Neil

Jane Lindsay Godbey

John Hamm

Vaishnavi "Vaishu" Bandaru

Tanguy Y Seiwert

Ammar Sukari

Douglas Adkins, MD

Lara Dunn, MD

Emmie Cole

Shetal Patel

Deonna Asbury

Lowell L Hart

Jeremy Cetnar

Lova Sun

Jimmy Rodrigues

Howard Safran

Guermarie Velazquez-Torres

Neal S. Akhave

Sonia Salas

Isaac Tafur

Cristina P Rodriguez

Neil Chua

Christophe Borg

Sebastien Salas

Claude El Kouri, MD

Jaafar Bennouna

Caroline Even

Christian Meyer

Alfredo Berruti

Pierfrancesco Tassone, MD

Giuseppe Curigliano

Fortunato Ciardiello

Mauro Iannopollo, MD

Claudia Casanova

Maria Garcia Pallas, MD

Beatriz Cirauqui

Alejandro Martinez

Irene Brana

Teresa Alonso Gordoa

Silvia Catot Tort, MD

Juan Coves Sarto

Medical Monitor

This trial will study tisotumab vedotin to find out whether it is an effective treatment alone or with other anticancer drugs for certain solid tumors and what side effects (unwanted effects) may occur. There are seven parts to this study.

* In Part A, the treatment will be given to participants every 3 weeks (3-week cycles).
* In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle.
* In Part C, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle.
* In Part D, participants will be given treatment on Day 1 of every 3-week cycle. Participants in Part D will get tisotumab vedotin with either:

  * Pembrolizumab or,
  * Pembrolizumab and carboplatin, or
  * Pembrolizumab and cisplatin
* In Part E, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle.
* In Part F, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part F will get tisotumab vedotin with pembrolizumab.
* In Part G, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part G will get tisotumab vedotin with pembrolizumab and carboplatin.

The primary goal of this trial is to assess the activity, safety, and tolerability of tisotumab vedotin for the treatment of selected solid tumors. Patients will be treated with single agent tisotumab vedotin or tisotumab vedotin in combination with other anticancer agents. Patients who meet eligibility criteria will be enrolled into cohorts based on tumor type. Tumor types to be evaluated include colorectal cancer, squamous non-small cell lung cancer (sqNSCLC), exocrine pancreatic adenocarcinoma, and head and neck squamous cell carcinoma (HNSCC).

Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors

Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors

Proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator

Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by BICR

Type, severity, and relatedness of adverse events. An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator

Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by BICR

Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by the investigator, or meet the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 12 weeks

Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by BICR, or meet the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 12 weeks

Time from the first documentation of objective response to the first documentation of PD or death due to any cause, whichever comes first, as assessed by the investigator

Time from the first documentation of objective response to the first documentation of PD or death due to any cause, whichever comes first, as assessed by BICR

Time from the start of study treatment to the first documentation of objective response, as assessed by investigator

Time from the start of study treatment to the first documentation of objective response, as assessed by BICR

Time from the start of study treatment to the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever comes first, as assessed by the investigator

Time from the start of study treatment to the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever comes first, as assessed by BICR

Time from the start of study treatment to date of death due to any cause

Observed plasma concentration at the end of the dosing interval

Genmab

Merck Sharp & Dohme LLC

Seagen Inc.

Gastrointestinal Agents

Omeprazole

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

Omeprazole, 80 mg, PO, BID for 2 weeks prior to surgical therapy of pancreatectomy. All 30 subjects in Arm A to be enrolled prior to Arm B cohort enrollment.

Omeprazole, 20 mg, PO, QD for 2 weeks prior to surgical therapy of pancreatectomy.

Treatment will consist of Omeprazole 2 weeks prior to surgical therapy of pancreatectomy.

SCC IIT Office

Ingrid Block

Ajay Jain, MD

The purpose of this study is to test the safety of high dose omeprazole and see what effects that it has on patients with exocrine pancreatic cancer.

During this study patients will receive treatment of omeprazole at the dose depending on group enrollment

* Group A will receive omeprazole 80 mg, twice a day for 14 days unless unacceptable toxicity
* Group B, will receive omeprazole 20 mg, once a day for 14 days

Patients will receive treatment for 2\~3 weeks during the study, and 2 months of follow up.

Total accrual is anticipated to take 2 years.

High Dose Omeprazole in Patients With Pancreatic Cancer

A Phase 0 Study of High Dose Omeprazole in Patients With Pancreatic Cancer Planning to Undergo Surgical Therapy for Evaluating Changes of Biomarkers

Proportion of subjects receiving study treatment without adverse events that would significantly delay the surgery

Frequency and severity of treatment related adverse events per CTCAE v5

v-ATPase LC3-I and LC3-II expression on pancreatic tumor

Correlation of biomarker changes with potential cancer cell apoptosis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine	NCT01020006	Pancreatic Canc... Ductal Adrenoca... Exocrine Pancre...	PCI-27483 Gemcitabine	18 Years -	Pharmacyclics LLC.
PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors	NCT04011982	Exocrine Pancre...		18 Years -	Centre Leon Berard
Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors	NCT03485209	Colorectal Neop... Carcinoma, Non-... Exocrine Pancre... Carcinoma, Squa...	tisotumab vedot... pembrolizumab carboplatin cisplatin	18 Years -	Seagen Inc.
High Dose Omeprazole in Patients With Pancreatic Cancer	NCT04930991	Exocrine Pancre...	Omeprazole	18 Years - 99 Years	University of Oklahoma
Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine	NCT01020006	Pancreatic Canc... Ductal Adrenoca... Exocrine Pancre...	PCI-27483 Gemcitabine	18 Years -	Pharmacyclics LLC.

Spots Global Cancer Trial Database for exocrine pancreatic cancer