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Trial · Interventional

TerminatedPhase 2Registry data

Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis

Short name PASIREOCHIP

NCTNCT04826432 (opens ClinicalTrials.gov in a new tab)Other id2019-002507-18Other id2019/2955Other id2019

Overview

Status
Terminated
Phase
Phase 2
Enrollment
6 participants (actual)
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris · Other
Design
Randomized · Single masking
Countries
1 country

France

Start
3 Sept 2020
Primary completion
7 Feb 2024
Completion
7 Feb 2024
First posted
1 Apr 2021
Last update posted
8 Feb 2024
Conditions
Peritoneal Carcinomatosis

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022202320242025
  1. Ph 2

    PASIREOCHIP

    NCT04826432

    3 Sept 2020 to 7 Feb 2024

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To assess the efficacy of pasireotide in the reduction of clinically relevant postoperative digestive leakage after CRS plus HIPEC compared to placebo

Interventions

  • Pasireotide 0.9 MG/MLDrug
  • Saline waterOther

Arms2

  • Experimental

    Pasireotide

    0.9 mg of pasireotide subcutaneously (s.c.) twice daily (14 doses) every 12 +/- 2 hours

  • Placebo comparator

    Placebo

    0.9 ml of saline water s.c. twice daily (14 doses) every 12 +/- 2 hours

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. postoperative digestive leakage

    Time frame · 97 days

    Registry description

    The rate of clinically relevant (NCI CTCAE v5 ≥ grade 3) postoperative digestive leakage at 97 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female patients aged between 18 years and 75 years included * ECOG (Eastern Cooperative Oncology Group) Performance Status ≤ 2 * Primary (pseudomyxoma peritonei, peritoneal mesothelioma) or Secondary (colorectal or ovarian) peritoneal malignancies * Curative intent resection obtained by a complete resection according to the Completeness of Cytoreduction score (CC) (CC 0-1) followed by HIPEC Different intraperitoneal drug administration modalities such as neoadjuvant systemic plus simultaneous intraperitoneal and intravenous chemotherapy (NIPS) or pressurized intra-peritoneal aerosol chemotherapy (PIPAC) does not represent exclusion criteria. * Absence of extra-peritoneal metastatic disease or limited hepatic or lung metastases easily amenable to curative-intent resection or ablation * Intraoperative Peritoneal Cancer Index (PCI score) ≥ 10 * Visceral resection with at least one digestive anastomosis with or without loop ileostomy or pancreatic or biliary resection. * Negative serum pregnancy test for women of childbearing potential within 7 days prior to therapy * Sexually active women of childbearing potential must agree to use a highly effective method of contraception or to abstain from sexual activity during the study and for 3 months after the last study treatment administration. Sexually active males patients must agree to use condom or to abstain from sexual activity during the study and for 3 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception during the same period. * Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol. * Patients must be affiliated to a social security system or beneficiary of the same Exclusion Criteria: * Macroscopically incomplete surgical resection (CC 2) * Standard contraindications to pasireotide: 1. patients with uncontrolled diabetes mellitus or a fasting plasma glucose \> 250mg/dl (14 mMol/L) 2. patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia including a corrected QT (QTc) interval longer than 450 msec, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment 3. patients with liver disease such as severe hepatic impairment (Child Pugh C), chronic active hepatitis or chronic persistent hepatitis with abnormal coagulation (INR\>1.5). 4. patients with the presence of active or suspected acute or chronic uncontrolled infection 5. hypersensitivity to somatostatin analogues or any component of pasireotide formulations 6. patients with uncontrolled hypothyroidism * Patients participating or who have participated to another study evaluating the effect of a new drug other than pasireotide within 1 month prior to dosing * Patient who have already participated to this study (a patient can only be included once in the study) * Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study. * Women who are pregnant or likely to be so, or who are breastfeeding * Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

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