Suspended

Aroplatin and Gemcitabine Combination Therapy for Unresectable, Locally Advanced and/or Metastatic Pancreatic Cancer

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What is being tested

Data Collection

Who is being recruted

Digestive System Diseases+9

+ Digestive System Neoplasms

+ Endocrine System Diseases

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
See protocol details

Summary

Principal SponsorAronex Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

This is a treatment study exploring the use of Aroplatin in combination with a drug called Gemcitabine (Gemzar®) in individuals diagnosed with pancreatic cancer that has spread or cannot be removed by surgery. The main goal of the first part of the study is to find the highest dose of this combination therapy that can be given safely without causing severe side effects. The second part of the study aims to evaluate how well patients respond to this treatment at the determined safe dose, focusing on their survival post-therapy. This research holds potential in improving treatment options for advanced pancreatic cancer, a condition where better therapies are urgently needed.

Official TitleA Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer
NCT00081549
Principal SponsorAronex Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

111 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasm MetastasisNeoplasmsNeoplasms by SiteNeoplastic ProcessesPancreatic DiseasesPancreatic NeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

10 inclusion criteria required to participate
Pancreatic cancer (AJCC Stage II-IV);
Unresectable cancer;
Measurable disease (RECIST criteria);
No prior therapy;
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7 exclusion criteria prevent from participating
Previously diagnosed brain metastases if symptomatic and requiring active therapy;
Other cancers within the last five years, with the exception of adequately treated cone-biopsied in-situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin;
Any serious concomitant medical or mental illness requiring intense therapy and interfering with participation in this study
Primary or secondary immunodeficiency, or use of corticosteroids immunosuppressive medication;
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers
Aroplatin and Gemcitabine Combination Therapy for Unresectable, Locally Advanced and/or Metastatic Pancreatic Cancer | PatLynk