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About
The purpose of this study is to determine the safety and efficacy of nab-paclitaxel combined with gemcitabine in Chinese patients with metastatic pancreatic cancer.
Full description
This is a Phase 2 trial in China to evaluate the safety and efficacy of the combination of nab-paclitaxel and gemcitabine administered in patients diagnosed with metastatic pancreatic adenocarcinoma. This study is designed to be a Chinese bridging study to complement the Global pivotal study (CA-046).
The study consists of three parts: (1) Dose evaluation; (2) Single arm to evaluate efficacy following an optimal Simon two-stage design; and (3) Randomized 2-arm to evaluate the efficacy and safety of nab-paclitaxel plus gemcitabine versus gemcitabine alone. These 3 parts will be carried out sequentially. The Part 3 randomized 2-arm portion will only be carried out if deemed necessary per protocol.
Enrollment
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Inclusion criteria
Patient has definitive histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (Islet cell neoplasms are excluded) that is measurable by Response Evaluation criteria for solid tumors (RECIST V1.0)
Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic pancreatic cancer. Prior treatment with 5-fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
Patient has a Karnofsky performance status (KPS) ≥ 70
Initial diagnosis of metastatic disease must have occurred ≤ 6 weeks prior to starting Cycle 1 Day 1. NOTE: the clock for this time interval starts with the date of last evaluation confirming pancreatic metastatic disease (either biopsy or imaging results)
Patients should be asymptomatic for jaundice prior to Cycle 1 Day 1. Significant or symptomatic amounts of ascites should be drained prior to Cycle 1 Day 1. Pain symptoms should be stable and should not require modifications in analgesic management prior to Cycle 1 Day 1
Patient has adequate blood counts at screening (obtained ≤ 14 days prior to starting Cycle 1 Day 1):
Patient has the following blood chemistry levels at Screening (obtained ≤ 14 days prior to starting Cycle 1 Day 1):
The patient has acceptable coagulation studies (obtained ≤14 days prior to starting Cycle 1 Day 1) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (WNL) ±15%.
The patient has no clinically significant abnormalities in urinalysis results (obtained ≤14 days prior to starting Cycle 1 Day 1).
Male or non-pregnant and non-lactating female, and ≥ 18 years of age at the time of signing the informed consent document.
Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to participation in any study-related activities.
Able to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
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83 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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