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To Assess the Safety of Continuous IV Administration of Plerixafor and Assess Impact on the Immune Microenvironment in Patients With Pancreatic, Ovarian and Colorectal Adenocarcinomas | Clinical Trials | Clareo Health

TERMINATEDPHASE1

To Assess the Safety of Continuous IV Administration of Plerixafor and Assess Impact on the Immune Microenvironment in Patients With Pancreatic, Ovarian and Colorectal Adenocarcinomas

To Assess the Safety of Continuous IV Administration of the CXCR4 Antagonist, Plerixafor at Potentially Active Plasma Concentrations and Assess Its Impact on the Immune Microenvironment in Patients With Advanced Pancreatic, High Grade Serous Ovarian and Colorectal Adenocarcinomas

NCT03277209•Weill Medical College of Cornell University

View on ClinicalTrials.gov

Summary

A dose escalation trial to assess the safety of plerixafor in patients with advanced pancreatic, high grade serous ovarian and colorectal cancer. To identify the proof of mechanism, by demonstrating alterations in T-cell tumour distribution, ideally associated with loss of tumour cells, measured by immunostaining, and changes in FDG uptake.

Detailed Description

This is a prospective, non-randomised, open label, Phase I, dose escalation trial of plerixafor in patients with histological documentation of advanced pancreatic, high grade serous ovarian or colorectal adenocarcinoma. We will investigate the feasibility of administering plerixafor in terms of safety, and will try to identify the proof of mechanism in patients. This trial will follow the standard 3+3, Phase I trial design, leading to a treatment expansion phase to confirm the RP2D.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 16 years or over (In the US, aged 18 years or over only).
•Dose escalation phase only: Patients with inoperable, histologically proven locally advanced or metastatic pancreatic, high grade serous ovarian or colorectal adenocarcinoma, refractory to conventional chemotherapy or a patient who has declined conventional chemotherapy OR;
•Treatment expansion phase only: Patients with inoperable, histologically proven locally advanced or metastatic pancreatic, refractory to conventional chemotherapy or a patient who has declined conventional chemotherapy.
•Tumour lesions considered to be accessible for core biopsy and immunostaining assessment.
•ECOG performance status 0-1.
•Life expectancy of at least 12 weeks.
•All women of child-bearing potential and all sexually active male patients must agree to use effective contraception methods throughout the trial and for 3 months after the final dose of trial drug.

Exclusion Criteria

•Inadequate haematological function defined by:
•* Absolute neutrophil count (ANC) \<1.5 x 109/L
•* Absolute lymphocyte count \<1.0 x 109/L (counts shall be rounded to the nearest tenth. (e.g. 0.96 will be rounded to 1.0 x 109/L))
•* Haemoglobin \<9.0 g/dL (90 g/L) (may be increased to this level with transfusion as long as there is no evidence of active bleeding)
•* Platelets \<100 x 109/L
•* Clotting; INR \>1.3
•Inadequate renal function defined by calculated creatinine clearance by Cockcroft-Gault of \<50 ml/min.
•Inadequate hepatic function defined by:
•* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 x upper limit of normal (ULN) or \>5 x in the presence of liver metastases
•* Total bilirubin \>1.5 x ULN
+12 more criteria

Locations (2)

Weill Cornell Medical College

New York, New York, United States

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Key Dates

Start Date

July 25, 2017

Primary Completion Date

December 30, 2019

Completion Date

December 30, 2019

Last Updated

March 2, 2020

Enrollment

ACTUAL participants

Conditions

Pancreas Cancer

Interventions

Plerixafor

DRUG

Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury

NCT04485286

Lung CancerRadiation Fibrosis+2 more

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RECRUITINGPHASE1/PHASE2

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

NCT04605913

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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To Assess the Safety of Continuous IV Administration of Plerixafor and Assess Impact on the Immune Microenvironment in Patients With Pancreatic, Ovarian and Colorectal Adenocarcinomas

Inclusion Criteria

Exclusion Criteria

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