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CompletedLast updated: 7 February 2024

This phase I trial is testing a new drug (CEND-1) in combination with chemotherapy (Nabpaclitaxel and Gemcitabine) in patients with exocrine pancreatic cancers that have spread to other parts of the bodyA Phase 1 Clinical Trial of CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Exocrine Pancreatic Cancer

Clinical summary

Summary

This trial involves a does escalation and expansion phase. In the dose escalation phase, participants will receive three different CEND-1 dose levels, first as a monotherapy and followed by combination therapy with nabpaclitaxel and gemcitabine. In the dose expansion phase, approximately 28 subjects will receive combination treatment with two different CEND-1 dose levels.

Conditions

This trial is treating patients with exocrine pancreatic cancer.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

DrugCendR

Scientific Title

A Phase 1 Clinical Trial of CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Exocrine Pancreatic Cancer

Eligibility

Inclusion

  • Patients with histologically confirmed metastatic pancreatic ductal carcinoma
  • One or more metastatic lesions measurable on MRI, PET/CT, or dedicated CT scan according to RECIST v1.1.
  • Eligible for treatment with nabpaclitaxel and gemcitabine
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of at least 3 months
  • Adequate archival tissue from prior biopsy for biomarker evaluation or willingness to undergo biopsy before treatment starts
  • The patient is capable of understanding and complying with the protocol and the subject or, when applicable, the subject's legally acceptable representative has signed the informed consent
  • A negative serum pregnancy test (if a premenopausal female patient)
  • Acceptable liver function: Bilirubin ≥ 1.5 times upper limit of normal; AST (SGOT) < 10 times upper limit of normal, ALT (SGPT) and Alkaline phosphatase 2.5 times upper limit of normal (if liver metastases are present, then ≤ 5 x ULN is allowed).
  • Acceptable renal function: Serum creatinine within normal limits; calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal by the Cockroft-Gault equation.
  • Acceptable hematologic status: Granulocyte ≥ 1500 cells/mm3; Platelet count ≥ 100,000 plt/mm3; Hemoglobin ≥ 9 g/dL.
  • Urinalysis: No clinically significant abnormalities.
  • Acceptable coagulation status: PT within normal limits; PTT within normal limits.
  • For men and women of child-producing potential, the use of effective contraceptive methods during the study.

Exclusion

  • Prior chemotherapy or any other investigational agents for the treatment of pancreatic cancer.
  • Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents.
  • Participants with known brain metastases.
  • New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
  • Pregnant or nursing women. Women of child-bearing potential and men must agree to use adequate contraception.
  • Unwillingness or inability to comply with procedures required in this protocol.
  • Known infection with HIV, hepatitis B, or hepatitis C.
  • Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions per physician judgement) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • 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.

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