CompletedPhase 3

2nd-line Therapy With Nal-IRI After Gem/Nab-pac in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy

Germany151 participantsStarted 2018-03-31

Plain-language summary

Second-line therapy with Nal-IRI after failure gemcitabine/nab-paclitaxel in advanced pancreatic cancer - predictive role of 1st-line therapy

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Written informed consent including participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
✓. Clinical indication for a 2nd-line systemic therapy according to current standard-of-care.
✓. Age ≥ 18 years at time of study entry
✓. Patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma
✓. Imaging of evaluable lesions within 2 weeks of inclusion (either sonography, X-ray, CT scans, MRI)
✓. ECOG performance status 0-2
✓. One line of systemic gemcitabine/Nab-paclitaxel -based therapy for advanced disease (irrespective of prior adjuvant therapy) OR Previous adjuvant gemcitabine/Nab-paclitaxel-based chemotherapy with documented progression less than 6 months after termination
✓. Detailed documentation of prior therapy (duration, dose-intensity, maximum toxicity, reason for discontinuation)

✕. Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to:
✕. Active uncontrolled infection, chronic infectious diseases, immune deficiency syndromes
✕. Premalignant hematologic disorders, e.g. myelodysplastic syndrome
✕. Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment
✕. Prior (\<3 years) or concurrent malignancy (other than biliary-tract cancer) which either progresses or requires active treatment. Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a or T1b prostate carcinoma, or superficial urinary bladder tumor \[Ta, Tis and T1\].
✕. Pre-existing lung disease of clinical significance or with impact on performance status
✕. History or clinical evidence of CNS metastases
✕. Allogeneic transplantation requiring immunosuppressive therapy or other major immunosuppressive therapy

Time to Treatment Failure of second-line treatment (TTF2)

Timeframe: up to 6 month

NCT IDNCT03468335

SponsorAIO-Studien-gGmbH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-31

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Written informed consent including participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
✓. Clinical indication for a 2nd-line systemic therapy according to current standard-of-care.
✓. Age ≥ 18 years at time of study entry
✓. Patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma
✓. Imaging of evaluable lesions within 2 weeks of inclusion (either sonography, X-ray, CT scans, MRI)
✓. ECOG performance status 0-2
✓. One line of systemic gemcitabine/Nab-paclitaxel -based therapy for advanced disease (irrespective of prior adjuvant therapy) OR Previous adjuvant gemcitabine/Nab-paclitaxel-based chemotherapy with documented progression less than 6 months after termination
✓. Detailed documentation of prior therapy (duration, dose-intensity, maximum toxicity, reason for discontinuation)

✕. Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to:
✕. Active uncontrolled infection, chronic infectious diseases, immune deficiency syndromes
✕. Premalignant hematologic disorders, e.g. myelodysplastic syndrome
✕. Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment
✕. Prior (\<3 years) or concurrent malignancy (other than biliary-tract cancer) which either progresses or requires active treatment. Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a or T1b prostate carcinoma, or superficial urinary bladder tumor \[Ta, Tis and T1\].
✕. Pre-existing lung disease of clinical significance or with impact on performance status
✕. History or clinical evidence of CNS metastases
✕. Allogeneic transplantation requiring immunosuppressive therapy or other major immunosuppressive therapy