Trial record 2 of 31 for:    celgene abi-007 | Open Studies

Safety and Efficacy Study of Abraxane Plus Gemcitabine in Chinese Patients With Metastatic Pancreatic Cancer (PANC-001)

This study is currently recruiting participants.
Verified March 2014 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT02017015
First received: December 5, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine the safety and efficacy of Abraxane combined with Gemcitabine in Chinese patients with metastatic pancreatic cancer.


Condition Intervention Phase
Pancreatic Neoplasms
Drug: Abraxane
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-center Study to Evaluate the Safety and Efficacy of ABI-007 Plus Gemcitabine in Chinese Patients With Metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The percentage of patients considered to have responded to therapy based on objective response rate by independent radiological review.


Secondary Outcome Measures:
  • Duration of response according to RECIST 1.0 guidelines [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    This analysis will only be conducted for patients that have a complete response or partial response. Defined as the time from first tumor assessment when the complete response/partial response criteria is met to the date of disease progression.

  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Number of patients alive

  • Adverse Events [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events


Estimated Enrollment: 82
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abraxane with Gemcitabine
Abraxane at 125 mg/m2, IV infusion over 30 to 40 minutes (maximum infusion time not to exceed 40 minutes) followed by gemcitabine at 1000 mg/ m2 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: Abraxane
Abraxane in combination with gemcitabine used in the initial treatment of metastatic pancreatic cancer for that patient
Other Name: ABI-007 and Gemzar
Drug: Gemcitabine
Abraxane in combination with gemcitabine used in the initial treatment of metastatic pancreatic cancer for that patient
Other Name: Abraxane in combination with gemcitabine used in the initial treatment of metastatic pancreatic cancer for that patient

Detailed Description:

This is a Phase 2 trial in China to evaluate the safety and efficacy of the combination of Abraxane and gemcitabine administered in patients diagnosed with metastatic pancreatic adenocarcinoma. Approximately 82-246 patients are planned to be accrued. 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 Abraxane 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has definitive histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (Islet cell neoplasms are excluded) that is measurable by RECIST
  2. Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic pancreatic cancer. Prior treatment with 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
  3. Patient has a Karnofsky performance status (KPS) ≥ 70
  4. 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)
  5. 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
  6. 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/mm3 (100 × 10^9/L);
    • Hemoglobin (Hgb) ≥ 9 g/dL
  7. 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 range , unless liver metastases are clearly present, then ≤ 5 × upper limit of normal range is allowed
    • Total bilirubin ≤ upper limit of normal range
    • Serum creatinine within normal limits or calculated clearance ≥ 60 mL/min/1.73 m2 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 Cockroft-Gault formula). For patients with a Body Mass Index (BMI) > 30 kg/m2, lean body weight should be used instead.
  8. 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 (±15%). (See also Section 6.2 for Screening PT/PTT analysis).
  9. Patient has no clinically significant abnormalities in urinalysis results (obtained ≤14 days prior to starting Cycle 1 Day 1).
  10. Male or non-pregnant and non-lactating female, and ≥ 18 years of age at the time of signing the informed consent document.

    • If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative pregnancy test (e.g. serum β-hCG) documented prior to the first administration of study drug.
    • If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drug. In addition, male and female patients must utilize contraception after the end of treatment as recommended in the product's Prescribing Information provided in the study manual.
  11. 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.
  12. Able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

Patient has known brain metastases 2. Patient has only locally advanced disease. 3. Patient has a ≥ 20% decrease in serum albumin level between Screening visit and within 72 hours prior to Cycle 1 Day 1.

4. 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.

5. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.

6. Patient has known infection with Human Immunodefiency 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).

7. 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.

8. 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 electrocardiogram (ECG) abnormality, within 6 months prior to Cycle 1 Day 1 9. 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 events outlined in the Contraindications or Special Warnings and Precautions sections of the product or comparator Prescribing Information.

10. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).

11. 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.

12. 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.

13. Patient is enrolled in any other clinical protocol or investigational trial with an interventional agent or assessments that may interfere with study procedures.

14. 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02017015

Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
China
Beijing Cancer Hospital Recruiting
Beijing, China
Contact    (+86) 88196175      
Peking Union Medical College Hospital Not yet recruiting
Beijing, China
Contact    (+86) 69158315      
Sun Yat Sen University Cancer Center Recruiting
Guangzhou, China
Contact    (+86) 87343228      
Sir Run Run Shaw Hospital Zhejiang University Recruiting
Hangzhou, China
Contact    (+86) 86006922      
The First Affiliated Hospital of Medical School of Zhejiang Not yet recruiting
Hangzhou, China
Contact    (+86) 56731277      
Jiangsu Provincial Tumor Hospital Not yet recruiting
Nanjing, China
Contact    (+86) 83284620      
Shanghai First People's Hospital Recruiting
Shanghai, China
Contact    (+86) 63240090      
Sponsors and Collaborators
Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT02017015     History of Changes
Other Study ID Numbers: ABI-007-PANC-001
Study First Received: December 5, 2013
Last Updated: March 10, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Celgene Corporation:
Pancreatic cancer
Metastatic pancreatic cancer
treatment for pancreatic cancer
Abraxane clinical research trials
Celgene clinical research trials

Additional relevant MeSH terms:
Paclitaxel
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 17, 2014