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Pancreatic NeoplasmsPhase 2PANC-001NCT02017015

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

A Phase 2 study testing nab-paclitaxel and Gemcitabine in people with Pancreatic Neoplasms, run by Celgene at 15 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Neoplasms
What is being tested?
nab-paclitaxel and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
15 sitesChina
Study dates
24 Dec 2013to 3 Aug 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
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  • 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).
  • 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-subunit of human chorionic gonadotropin (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
  • 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.
  • Able to adhere to the study visit schedule and other protocol requirements.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • 307 Hospital of Chinese PLA

    Beijing, 100039

  • Peking Union Medical College Hospital

    Beijing, 100730

  • Chinese PLA General Hospital

    Beijing, 100853

  • Beijing Cancer Hospital

    Beijing, PR, 100142

  • Sun Yat-sen University Cancer Center

    Guangzhou, 510060

  • Zhejiang Cancer Hospital

    Hangzhou, 215006

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

    Hangzhou, Zhejiang, 100142

  • The First Affiliated Hospital of Medical School of Zhejiang University

    Hangzhou, Zhejiang, 100730

  • Harbin Medical University Tumor Hospital

    Harbin, Heilongjiang, 150081

  • Jiangsu Province Hospital The First Hospital affiliated with Nanjing Medical University

    Nanjing, 210029

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Shanghai First People's Hospital

    Shanghai, 200080

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060

  • Xijing Hospital

    Xi'an, 710032

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

About this study

Official title: A PHASE 2, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ABI-007 PLUS GEMCITABINE IN CHINESE PATEINTS WITH METASTATIC PANCREATIC ADENOCARCINOMA

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.

Read the 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.

Keywords
Pancreatic cancer, Metastatic pancreatic cancer, treatment for pancreatic cancer, Abraxane clinical research trials, Celgene clinical research trials
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nab-paclitaxelDrug

    Also called ABI-007, Abraxane

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

  • GemcitabineDrug

    Also called Gemzar

    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).

Study groups in NCT02017015
Study groupRoleWhat they receive
nab-paclitaxel with gemcitabineExperimentalnab-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).
Receives: Drug: nab-paclitaxel; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)

    TEAEs were defined as adverse events (AEs) that began or worsened in severity on or after the date of the first dose of study drug and within 30 days of the last dose of study drug. A Serious AE (SAE) = any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, is a congenital anomaly/birth defect; constitutes an important medical event. Treatment-related AEs (TRAEs) were any TEAEs considered to be related to the study drug. A TRAE is a TEAE with relationship as suspected to either ABI-007 or gemcitabine The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Other AEs not described in the CTCAE criteria, the intensity will be assessed by the investigator as mild grade (Gr 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)

    Measured: 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

  2. Duration of Response (DoR) Based on IRR According to RECIST Guidelines

    DoR was defined as the time from the first tumor assessment when the confirmed CR/PR response criterion is met to the date of disease progression based on IRR following RECIST 1.0. Only for those participants with a confirmed CR/PR. If a participant had disease progression, then the date of disease progression was the event date. For a participant who did not develop disease progression or disease progression occurred after 2 or more missing tumor assessments, the participant was censored on the date of last tumor assessment where the participant was documented to be progression free. If a participant died prior to disease progression, the participant was censored on the date of death. If patient started new anti-cancer therapy, the patient was censored on the last tumor assessment date on or prior to the start date of new anti-cancer therapy

    Measured: Assessment performed every 8 weeks; from the first participant enrolled to cut off date of 01 June 2015; up to approximately 70 weeks

  3. Kaplan-Meier Estimate of Overall Survival (OS)

    Overall survival was defined as the time from the date of first treatment to the date of death. Participants who did not die at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cut-off date, whichever was earlier.

    Measured: From the first participant enrolled to data cut off of 01 June 2015; up to approximately 70 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2013 (estimated)
  2. Study start24 Dec 2013
  3. Primary completion1 Jun 2015
  4. Study completion3 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02017015
Sponsor's protocol ID
ABI-007-PANC-001
Acronym
PANC-001
Status last verified
Aug 2017
First submitted
5 Dec 2013
Last updated
26 Sep 2017
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nab-paclitaxel and Gemcitabine in people with Pancreatic Neoplasms, run by Celgene at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02017015.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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