Safety and Efficacy Study of Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Metastatic Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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]. Number, participants. At least 1 TEAE: Nab-paclitaxel and Gemcitabine (n=83): 83. At Least 1 Treatment-related TEAE: Nab-paclitaxel and Gemcitabine (n=83): 82. ≥ 1 TEAE with NCI CTCAE Gr 3 or higher: Nab-paclitaxel and Gemcitabine (n=83): 70. ≥ 1 TRAE NCI CTCAE ≥ Gr 3: Nab-paclitaxel and Gemcitabine (n=83): 62. At Least 1 Serious TEAE: Nab-paclitaxel and Gemcitabine (n=83): 20. At Least 1 Treatment-related Serious TEAE: Nab-paclitaxel and Gemcitabine (n=83): 9. ≥ 1 TEAE causing discontinuing of either drug: Nab-paclitaxel and Gemcitabine (n=83): 10. ≥1 TRAE causing discontinuing of either drug: Nab-paclitaxel and Gemcitabine (n=83): 5. ≥ 1 TEAE causing reduction in ABI-007/Gemcitabine: Nab-paclitaxel and Gemcitabine (n=83): 38. ≥ 1 TRAE causing reduction in ABI-007/Gemcitabine: Nab-paclitaxel and Gemcitabine (n=83): 38. ≥1 TEAE causing interruption in either study drug: Nab-paclitaxel and Gemcitabine (n=83): 43. ≥1 TRAE causing interruption in either study drug: Nab-paclitaxel and Gemcitabine (n=83): 40. At Least 1 TEAE With Outcome of Death: Nab-paclitaxel and Gemcitabine (n=83): 8. ≥1 TRAE with Outcome of Death: Nab-paclitaxel and Gemcitabine (n=83): 2.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Response Rate (ORR) Based on Independent Radiological Review (IRR) [Assessment every 8 weeks; Day 1 to data cut off of 01 June 2015; Up to approximately 70 weeks]. Number, percentage of participants (95% Confidence Interval). Nab-paclitaxel and Gemcitabine (n=83): 35 (24.8 to 46.2).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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]. Median, months (95% Confidence Interval). Nab-paclitaxel With Gemcitabine (n=29): 8.9 (6.01 to 8.94).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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]. Median, months (95% Confidence Interval). Nab-paclitaxel With Gemcitabine (n=83): 9.2 (7.60 to 11.10).