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

NCT02017015 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ABI-007-PANC-001
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 15

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.

Conditions

Pancreatic Neoplasms

Keywords

Pancreatic cancer; Metastatic pancreatic cancer; treatment for pancreatic cancer; Abraxane clinical research trials; Celgene clinical research trials

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) Based on Independent Radiological Review (IRR)

  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.

  Assessment every 8 weeks; Day 1 to data cut off of 01 June 2015; Up to approximately 70 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

nab-paclitaxel with gemcitabine

EXPERIMENTAL

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).

Drug: nab-paclitaxel; Drug: Gemcitabine

Interventions

nab-paclitaxel DRUG

nab-paclitaxel at 125 mg/m\^2, by IV infusion over 30 to 40 minutes (maximum infusion time not to exceed 40 minutes)

Also known as: ABI-007, Abraxane

nab-paclitaxel with gemcitabine

Gemcitabine DRUG

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).

Also known as: Gemzar

nab-paclitaxel with gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L;
• Platelet count ≥ 100,000/mm\^3 (100 × 10\^9/L);
• Hemoglobin (Hgb) ≥ 9 g/dL
• Patient has the following blood chemistry levels at Screening (obtained ≤ 14 days prior to starting Cycle 1 Day 1):
• Aspartate aminotransferase (SGOT) and alanine transaminase (SGPT) are ≤ 2.5 upper limit of normal (ULN) range, unless liver metastases are clearly present, then ≤ 5 × upper limit of normal (ULN) range is allowed
• Total bilirubin ≤ upper limit of normal range
• Serum creatinine within normal limits or calculated clearance ≥ 60 mL/min/1.73 m\^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockcroft-Gault formula). For patients with a body mass index (BMI) \> 30 kg/m\^2, lean body weight should be used instead.
• 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).

You may not qualify if:

• 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 1.
• 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).
• Patients with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
• Patient has any condition, including serious medical risk factors, medical conditions, laboratory abnormalities or psychiatric disorders, which could compromise the patient's safety or the study data integrity.
• Patient is enrolled in any other clinical protocol or investigational trial with an interventional agent or assessments that may interfere with study procedures.
• Patient is unwilling or unable to comply with study procedures, or is planning to take vacation for 7 or more consecutive days during the treatment phase of the study.

Sponsors & Collaborators

• Celgene: lead

Study Sites (15)

307 Hospital of Chinese PLA

Beijing, 100039, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Chinese PLA General Hospital

Beijing, 100853, China

Location

Beijing Cancer Hospital

Beijing, PR, 100142, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, 510060, China

Location

Zhejiang Cancer Hospital

Hangzhou, 215006, China

Location

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 100142, China

Location

The First Affiliated Hospital of Medical School of Zhejiang University

Hangzhou, Zhejiang, 100730, China

Location

Harbin Medical University Tumor Hospital

Harbin, Heilongjiang, 150081, China

Location

Jiangsu Province Hospital The First Hospital affiliated with Nanjing Medical University

Nanjing, 210029, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Shanghai First People's Hospital

Shanghai, 200080, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

Location

Xijing Hospital

Xi'an, 710032, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
• Organization: Celgene Corporation

ClinicalTrialDisclosure@celgene.com

888-260-1599

Study Officials

• Brian Lu, MD

  Celgene

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 20, 2013
• Study Start: December 24, 2013
• Primary Completion: June 1, 2015
• Study Completion: August 3, 2016
• Last Updated: September 26, 2017
• Results First Posted: November 22, 2016

Record last verified: 2017-08

Locations

CN (15)