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A Randomized Phase III Study of Weekly ABI-007 plus Gemcitabine versus Gemcitabine Alone in Patients with Metastatic Adenocarcinoma of the PancreasUnique Data Set IDPancrea_Celgene_2008_132
Clinical Trial Title
A Randomized Phase III Study of Weekly ABI-007 plus Gemcitabine versus Gemcitabine Alone in Patients with Metastatic Adenocarcinoma of the Pancreas
Trial Summary and Conditions
This is an open-label, randomized, multi-center, Phase III trial to compare ABI-007 in combination with gemcitabine administered weekly to standard treatment (gemcitabine monotherapy) with respect to overall survival, objective tumor response rate and PFS in patients diagnosed with metastatic adenocarcinoma of the pancreas. Patients will be randomized to one of the following treatment regimens: • ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest or • Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward). Test Product, Dose, and Mode of Administration: ABI-007 plus gemcitabine: ABI-007 125 mg/m2, IV infusion over 30-minute, followed by gemcitabine 1000 mg/m2 as a 30-minute IV infusion; weekly for 3 weeks (on Days 1, 8, and 15) followed by a week of rest. Gemcitabine alone: gemcitabine 1000 mg/m2 as a 30-minute IV infusion: Cycle 1 - administered weekly for 7 weeks followed by a week of rest. Cycle 2 onwards - weekly administration for 3 weeks (on Days 1, 8, and 15) followed by a week of rest. Duration of Treatment: Patients may continue on treatment until they experience progressive disease or unacceptable toxicity, require palliative radiotherapy, withdraw consent, or their physician feels it is no longer in their best interest to continue on treatment. Efficacy Assessments: Patients will have CT scans performed every 8 weeks and evaluated by a blinded, centralized reading center using the RECIST guidelines for complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). Functional tumor response will be evaluated by PET scans performed every 8 weeks. CA19-9 response will be assessed by radioimmunoassay.
All data collected are from the comparator arm. This de-identified data set represents 315 patients enrolled from an FDA-approved comparator treatment arm: gemcitabine monotherapy. A total of 630 patients were accrued to the study globally.
The primary objective of this study is to evaluate the efficacy of the combination of ABI-007 and gemcitabine versus gemcitabine alone in improving overall survival in patients with metastatic adenocarcinoma of the pancreas. The secondary objectives of this study are to: • Evaluate the objective tumor response and progression-free survival according to RECIST criteria. • Evaluate the safety and tolerability of this combination in this patient population. • Evaluate functional tumor response according to EORTC criteria. • Evaluate change in CA19-9 levels. • Evaluate secreted protein acidic and rich in cysteine (SPARC) in tumor tissue and peripheral blood and determine its possible correlation with efficacy outcomes.
The primary efficacy endpoint of this study will be the overall survival of patients treated with ABI-007 in combination with gemcitabine compared to patients treated with gemcitabine alone. The secondary efficacy endpoints are: • Objective tumor response based on CT scans (or MRI scans, if patient is allergic to contrast agent or has some other contraindication to a CT scan). These will be evaluated according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria • Progression-free survival
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PROTOCOL: CA046 Protocol FINAL.pdf
CRF: CA046 Annotated Study Book.pdf
DATA DICTIONARY: CA046 Data Dictionary Placeholder.docx
DATA (COMPARATOR ARM): CA046 data.zip