Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Behaviors and Mental Disorders

Pancreatic Neoplasms

Fatigue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Quality of Life

The control arm corresponds to usual care (without APA), including :

* Weekday hospital chemotherapy (every 7 or 14 days, depending on chemotherapy protocol)
* Evaluation by the oncologist at the usual rate
* Assessment every 8 weeks (TAP scan + CA-19.9)
* Nutritional, psychological and pain management as recommended, according to the usual schedule.

The experimental arm corresponds to usual care, combined with a 16-week APA program.

The APA program consisted of personalized aerobic and resistance exercises, with a weekly remote supervision by an APA professional trainer, and unsupervised sessions with a family member or friend (APA partner).

without APA program

Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)

APA program

Pascal Hammel, MD

Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for patients with unresectable pancreatic cancer.

Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population

The benefit of Adapted Physical Activity (APA) has been demonstrated after cancer diagnosis in term of symptomatic improvement: reducing fatigue, pain and improving the quality of life, psychological and emotional state, and adherence to treatment.

The aim of the study is to assess the effects of an APA program in pancreatic cancer population treated by usual chemotherapy.

200 randomized patients are required.

The program is organized in 16 weeks. During the trial, assessments include: aerobic exercises, muscular strength, six-minute walk test, body composition (bioimpedance, L3 CT-scan), level of physical activity - International Physical Activity Questionnaire - (IPAQ questionnaire), fatigue - Multidimensional Fatigue Inventory - (MFI-20 questionnaire), quality of life - EORTC Quality of Life questionnaire C-30 - (EORTC QLQ-30 questionnaire), depression symptom - Hospital Anxiety and depression scale - (HADS questionnaire), pain (Brief Pain Inventory Short form), and nutritional evaluation (BMI, ingests EVA).

Furthermore, relationships between insulin resistance, insulin secretion, Insulin like Growth Factor 1 (IGF-1) and pancreatic carcinogenesis exist. APA may improve the quality of life in decreasing insulin-resistance, insulin secretion and IGF-1.

Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer

Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

HRQoL at week 16 according to the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) with three targeted dimensions: global health status, physical function and fatigue.

Nutritional Status will be measured by weigth, Body Mass Index, body composition, EVA ingests, caloric intake and protidic, albumin/prealbumin, inflammation markers (PNN and CRP)

Six minutes walk test, dyspnea scale, Borg scale, muscular pain, strength test with bands and compliance program

GERCOR - Multidisciplinary Oncology Cooperative Group

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Neoplasm Metastasis

Head and Neck Neoplasms

Neoplasms, Squamous Cell

Carcinoma

Neoplastic Processes

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Herbal and Botanical

All Drugs and Chemicals

Cola

TAK-186 initial 60 minutes infusion and 30 minutes subsequent infusions on Day 1 of every week in Dose Escalation Phase. Participants may receive additional treatment with TAK-186. Dose escalation will be carried out in sequential cohorts of escalating doses.

Participants with non-small cell lung cancer (NSCLC) will be randomized to receive low dose or high dose of RDE of TAK-186 infusion on Day 1 of every week during Dose Expansion Phase of the study. Participants may receive additional treatment with TAK-186. Based on the results for this cohort additional cohorts for HNSCC and CRC, may be enrolled.

TAK-186

Takeda Contact

Site Contact

Bridget Keenan

Tejas Patil

So Yeon Kim

Marcus Dr. Noel

Site Cotact

Anita Turk, Dr.

Heather Beckwith

Steven Powell, Dr

Heidi McKean

Douglas Orr

George Blumenschein, Dr

Sarah Sutherland, Dr

Charlotte Lemech

Ganessan Kichenadasse

Sophia Frentzas

Andrew Haydon

Andrew Weickhardt

Bhumsuk Keam

Myung-Ju Ahn

Study Director

The main aim of this study is to check for side effects and tolerability of TAK-186 (also known as MVC-101) in adults with unremovable advanced or metastatic cancer. Another aim is to characterize and evaluate the activity of TAK-186 (MVC-101).

Participants may receive treatment throughout the study for a maximum of 13 months and will be followed up at 30 days and 90 days and then every 12 weeks for up to 48 weeks after the last treatment.

This Phase 1/2, open-label study will characterize safety and dose-limiting toxicities (DLTs) of TAK-186. Dose escalation will occur in participants with advanced solid tumors. A Cohort Expansion Phase will be enrolled to further characterize safety and initial anti-tumor activity in participants with solid tumors expressing epidermal growth factor receptor (EGFR), including HNSCC, CRC or NSCLC.

A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer

A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-186 (Also Known as MVC-101), An EGFR x CD3 COnditional Bispecific Redirected Activation (COBRA) Protein in Patients With Unresectable Locally Advanced or Metastatic Cancer

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All non immune-related AEs with start date from first dose of study drug until 30 days after the last dose of study drug will be considered as TEAEs. All immune-related AEs with start date from first dose of study drug until 90 days after the last dose of study drug will be considered as TEAEs. AEs will be reported based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.

Number of participants with infusion reactions as per American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria will be reported. Grade 1 - Mild (Symptomatic Management): Fever ≥38\^o C, No hypotension, No hypoxia, Grade 2 - Moderate (Moderate Intervention): Fever ≥38\^ o C, Hypotension not requiring vasopressors, Hypoxia requiring low-flow nasal cannula or blow-by oxygen, Grade 3 - Severe (Aggressive Intervention): Fever ≥ 38\^ o C , Hypotension requiring a vasopressor with or without vasopressin, Hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask, Grade 4 - Life-threatening (Life-sustaining intervention): Fever ≥38\^oC, Hypotension requiring multiple vasopressors (excluding vasopressin), Hypoxia requiring positive pressure (e.g. Continuous positive airway pressure, BiPAP, intubation and mechanical ventilation).

ORR will be calculated based on the percentage of participants achieving Complete Response \[CR\] or Partial Response \[PR\] as per RECIST v1.1 (both confirmed and unconfirmed) and modified RECIST v1.1.

Duration of response will be calculated for responders as the time from initial confirmed objective response (CR or PR) to the time of documented Progressive Disease (PD) using both RECIST v1.1 and modified RECIST v1.1 or death from any cause, whichever occurs first.

PFS will be calculated as the time from the date of the first dose of study drug to the date of any documented confirmed PD using both RECIST v1.1 and modified RECIST v1.1 or the date of death from any cause, whichever occurs first.

OS will be calculated as the time from the first dose of study drug until the date of death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer	NCT02184663	Unresectable Lo... Metastatic Panc...	without APA pro... APA program	18 Years -	GERCOR - Multidisciplinary Oncology Cooperative Group
A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer	NCT04844073	Squamous Cell C... Non-small Cell ... Colorectal Canc...	TAK-186	18 Years -	Takeda

Spots Global Cancer Trial Database for unresectable locally advanced cancer