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CompletedLast updated: 7 February 2024

This Phase I trial is evaluating the effectiveness of a new cancer treatment (PTM-101) in people with boderline resectable or locally advanced pancreatic cancerA Phase I Study of PTM-101 as Neoadjuvant Therapy for Borderline Resectable or Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

Clinical summary

Summary

PTM-101 is a biodegradable device containing 100mg of paclitaxel. PTM-101 will be placed onto the pancreatic surface overlying the tumour via a laparoscopy. PTM-101 will degrade over approximately 10 weeks.

Conditions

This trial is treating patients with pancreatic ductal adenocarcinoma.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

PanTher Therapeutics and Avania Clinical

Scientific Title

A Phase I Study of PTM-101 as Neoadjuvant Therapy for Borderline Resectable or Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility

Inclusion

1. EUS accessible, biopsy proven PDAC with borderline resectable or locally advanced disease by imaging criteria in accordance with International Consensus Guidelines (S Isaji, 2018)
2. No radiographic evidence of metastatic disease
3. No prior therapy for PDAC
4. ECOG 0 or 1
5. Clinically determined to be able to tolerate neoadjuvant therapy

Exclusion

 

1. Any other active malignancy
2. Known HIV or active viral hepatitis
3. Active ongoing infection or autoimmune disease which would preclude administration of chemotherapy or surgical intervention
4. Inability to comply with activities and therapeutic interventions as outlined
5. Currently enrolled in another investigational drug or device trial
6. Women who are pregnant or breastfeeding

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

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Completed hospitals

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