İlerlemiş Pankreas Adenokarsinomunda Birinci Basamak Kemoterapi Olarak Ramucirumab ile Standart Nab-paclitaxel ve Gemcitabine Kombinasyonu

Sade dilde özet

Bu çalışma, ilerlemiş pankreas adenokarsinomu (advanced pancreatic adenocarcinoma) olan hastalarda birinci basamak tedavi olarak Ramucirumab ilacının standart Nab-paclitaxel ve Gemcitabine kemoterapisine eklenmesini değerlendirmektedir. Çalışmaya, metastatik veya ameliyatla çıkarılamayan hastalığı olan, daha önce metastatik hastalık için tedavi almamış 18 yaş ve üzeri hastalar katılabilmiştir. Çalışma Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

PHASE1/PHASE2

Durum

Tamamlandı

Sponsor

Hellenic Cooperative Oncology Group

Müdahale

Ramucirumab

Başlangıç

29.01.2019

Tahmini bitiş

23.04.2023

Ülkeler

Greece

İlgili genler

Merkezler

• Athens, Greece
• Athens, Greece
• Chaïdári, Greece
• Cholargós, Greece
• Neo Faliro, Greece
• Psychikó, Greece
• Athens, Greece
• Athens, Greece
• Rio, Greece
• Thessaloniki, Greece
• Athens, Greece
• Ioannina, Greece
• Larissa, Greece

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

1. Signed and dated written informed consent
2. Histologically or cytologically proven pancreatic adenocarcinoma.
3. Metastatic or locally advanced unresectable disease confirmed clinically/radiologically by CT-scan or MRI (Magnetic Resonance Imaging)
4. No prior therapy for metastatic disease.
5. At least one measurable or evaluable lesion as assessed by CT-scan or MRI according to RECIST v1.1
6. Age 18 years,
7. ECOG Performance status (PS) 0-1
8. The patient has adequate hepatic function as defined by a total bilirubin 1.5 mg/dL (25.65 μmol/L), and aspartate transaminase (AST) and alanine transaminase (ALT) 2.5 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases)
9. Female patients must commit to using reliable and appropriate methods of contraception during the trial until at least three months after the end of study treatment (when applicable). Male patients with a partner of childbearing potential must agree to use contraception in addition to having their partner use another reliable contraceptive method during the trial until at least 6 months after the end of study treatment.
10. Patients must have a low or intermediate risk of arterial or venous thrombotic events (Khorana risk score 0-2). Patients at a high VTE risk (Khorana RS3) are eligible if they receive LMWH prophylaxis (Appendix D).

Exclusion Criteria:

1. The patient has pancreatic cancer with histology other than adenocarcinoma
2. Prior therapy for metastatic disease. Adjuvant Gemcitabine is permitted if 6 or more months have elapsed from last cycle to date of relapse.
3. Exclusive presence of bone metastasis only
4. Concomitant unplanned antitumor therapy
5. Treatment with any other investigational medicinal product within 28 days prior to study entry
6. Other serious and uncontrolled non-malignant chronic disease
7. The patient has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
8. The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal antiinflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325mg/day) is permitted.
9. The patient has experienced grade 3-4 gastrointestinal bleeding (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis within 3 months prior to first dose of protocol therapy.
10. Other concomitant or previous malignancy
11. The patient has symptomatic congestive heart failure (CHF; New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia
12. Bowel obstruction
13. The patient has a prior history of GI perforation/fistula (within 6 months of first dose of protocol therapy) or risk factors for perforation.
14. Palliative radiation therapy within 4 weeks prior to registration
15. The patient has a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to first dose of protocol therapy.
16. High risk for arterial or venous thrombotic complications as depicted by a Khorana Risk Score higher than 2 and inability to receive prophylaxis with low molecular weight heparin.