A PHASE 2, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ABI-007 PLUS GEMCITABINE IN CHINESE PATEINTS WITH METASTATIC PANCREATIC ADENOCARCINOMA
Overview
- Phase
- Phase 2
- Intervention
- nab-paclitaxel
- Conditions
- Pancreatic Neoplasms
- Sponsor
- Celgene
- Enrollment
- 83
- Locations
- 15
- Primary Endpoint
- Overall Response Rate (ORR) Based on Independent Radiological Review (IRR)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
- •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
- •Significant or symptomatic amounts of ascites should be drained prior to Cycle 1 Day
- •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):
- •Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L;
Exclusion Criteria
- •Patient has known brain metastases
- •Patient has only locally advanced disease.
- •Patient has a ≥ 20% decrease in serum albumin level between Screening visit and within 72 hours prior to Cycle 1 Day
- •History of malignancy in the last 5 years (including chronic leukemias). Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
- •Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- •Patient has known infection with human immunodeficiency virus, and/or active infection with hepatitis B, or hepatitis C (patients with known historical infection with hepatitis B or C should be discussed with the Sponsor).
- •Patient has undergone major surgery, other than diagnostic surgery (ie, surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
- •Patient that has a history of a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, seizure disorder or clinically significant cardiac dysrhythmia or ECG abnormality, within 6 months prior to Cycle 1 Day 1
- •Patient has a history of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the adverse events .
- •History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).
Arms & Interventions
nab-paclitaxel with gemcitabine
nab-paclitaxel at 125 mg/m\^2, intravenous (IV) infusion over 30 to 40 minutes followed by gemcitabine at 1000 mg/ m\^2 IV infusion over 30 to 40 minutes given once weekly for 3 weeks (Days 1, 8 and 15) followed by a week of rest (28 day cycle).
Intervention: nab-paclitaxel
nab-paclitaxel with gemcitabine
nab-paclitaxel at 125 mg/m\^2, intravenous (IV) infusion over 30 to 40 minutes followed by gemcitabine at 1000 mg/ m\^2 IV infusion over 30 to 40 minutes given once weekly for 3 weeks (Days 1, 8 and 15) followed by a week of rest (28 day cycle).
Intervention: Gemcitabine
Outcomes
Primary Outcomes
Overall Response Rate (ORR) Based on Independent Radiological Review (IRR)
Time Frame: Assessment every 8 weeks; Day 1 to data cut off of 01 June 2015; Up to approximately 70 weeks
ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) based on independent radiological review per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Using RECIST Version 1.0, participants were to achieve either a complete response defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the independent radiological review of best overall response during study treatment.
Secondary Outcomes
- Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)(Study drug initiation through 30 days after the last dose of study drug or End Of Study, whichever is later; maximum treatment duration was 54.9 weeks)
- Duration of Response (DoR) Based on IRR According to RECIST Guidelines(Assessment performed every 8 weeks; from the first participant enrolled to cut off date of 01 June 2015; up to approximately 70 weeks)
- Kaplan-Meier Estimate of Overall Survival (OS)(From the first participant enrolled to data cut off of 01 June 2015; up to approximately 70 weeks)