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Metastatic Pancreatic CancerPhase 2PGPC1NCT01461915

Phase 2 Study to Assess the Efficacy & Safety of Gemcitabine + Nab Paclitaxel With or Without Dociparstat in Metastatic Pancreatic Cancer Patients

A Phase 2 study testing Nab paclitaxel, Gemcitabine and Dociparstat in people with Metastatic Pancreatic Cancer, run by Jazz Pharmaceuticals at 16 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized, Phase 2, open label study aims to assess the efficacy and safety of gemcitabine + nab paclitaxel with or without dociparstat (ODSH) as first line treatment of metastatic pancreatic cancer. This study consists of 2 periods: a Run-in Period and a Randomized Period. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Nab paclitaxel, Gemcitabine and Dociparstat
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
16 sitesUnited States
Study dates
Nov 2011to Jun 2015
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all the following criteria to be eligible for this study:
  • Has histologically confirmed adenocarcinoma of the pancreas that is metastatic and for which potential curative measures, such as resection of an isolated metastasis, are not available. Patients with islet cell neoplasms will be excluded.
  • Has ≥ 1 metastatic tumors measurable by computerized tomography (CT) scan AND a serum carbohydrate antigen (CA) 19-9 measurement >2 times the upper limit of normal. Patients must have measurable disease, defined as at least 1 lesion that could be accurately measured in at least 1 dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
  • Is male or non-pregnant and non-lactating female and ≥ 18 to ≤ 75 years of age. If a female patient is of child-bearing potential, she must have a negative serum pregnancy test documented within 72 hours prior to the first administration of study drug and on Day 1 of each cycle thereafter. If sexually active, the patient must agree to use contraception prior to study entry and for the duration of study participation.
  • Must have received no prior radiotherapy or chemotherapy for metastatic disease. Patients who have received radiotherapy or chemotherapy as adjuvant or neo-adjuvant therapy for locally advanced disease 6 months or more prior to enrollment into this study are eligible.
  • Has adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤14 days prior to randomization) and at Baseline-Day 0: Absolute neutrophil count (ANC) ≥1.5 × 109/L; Platelet count ≥ 100,000/mm3 (100 × 109/L); Hemoglobin (Hgb) ≥ 9 g/dL.
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  • Has the following blood chemistry levels at Screening (obtained ≤14 days prior to randomization) and at Baseline-Day 0:
  • Aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are present, then ≤5 × ULN is allowed. Total bilirubin ≤1.5 × ULN.
  • Serum creatinine (Cr) within normal limits or calculated clearance ≥60 mL/min/1.73 m2 for patients with creatinine (Cr) levels above or below the institutional normal value. If using Cr clearance, actual body weight should be used for calculating Cr clearance (e.g., using the Cockcroft-Gault formula).
  • Has acceptable coagulation studies at Screening (obtained ≤14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (±15%).
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤1.
  • Has been informed about the nature of the study, and agrees to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.

Who cannot join

  • If a patient meets any of the following criteria, they are not eligible to participate in this study:
  • Has brain metastases.
  • Has only locally advanced disease.
  • Has experienced an increase of ECOG score to >1 between Screening and Randomization.
  • Requires continuous treatment with coumadin or other oral or parenteral anticoagulation (heparin, low molecular weight heparin [LMWH], heparinoids) to prevent or treat thromboembolic disease. The use of prophylactic antiplatelet drugs such as clopidogrel and aspirin are allowed before and during the study.
  • Has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
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  • Has undergone major surgery, other than diagnostic surgery (i.e., surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Randomization in this study.
  • Has a history of allergy or hypersensitivity to any of the study drugs, their pharmaceutical class, or any of their excipients.
  • Has a concomitant serious medical or psychiatric illness that, in the opinion of the Investigator, could compromise the patient's safety or the study data integrity.
  • Is enrolled in any other clinical protocol or investigational trial that involves administration of anti-neoplastic compounds for the treatment of metastatic pancreatic cancer.
  • Is unwilling or unable to comply with study procedures.
  • Nab-paclitaxel is metabolized by cytochrome P450 (CYP) 2C8 and CYP3A4. Co-administration of substrates, inhibitors of CYP2C8 and/or CYP3A4 with nab-paclitaxel is not allowed. The following medications and substances are not allowed during the study: ritonavir, saquinavir, indinavir, nelfinavir, rifampicin, carbamazepine, phenytoin, efavirenz, or nevirapine, grapefruit (juice or seeds) or some herbals like St. John's wort.
  • Has risk factors for or a history of Torsades des Pointes (TdP), or a significant QT prolongation that, in the opinion of the Investigator, may place the patient at risk.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Summa Health System - Cooper Cancer Center

    Akron, Ohio, 44304

  • Disney Family Cancer Center

    Burbank, California, 91505

  • Medical University of South Carolina Hollings Cancer Center

    Charleston, South Carolina, 29425

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • Indiana University Health, Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Marin Cancer Care

    Greenbrae, California, 94904

  • Scripps Clinic Torrey Pines ( Green Hospital)

    La Jolla, California, 92037

  • Loyola University Medical Center/Cardinal Bernardin Cancer Center

    Maywood, Illinois, 60153

  • Thomas Jefferson University [Kimmel Cancer Center]

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • South Texas Oncology & Hematology

    San Antonio, Texas, 78229

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Fesit-Weiller Cancer Center

    Shreveport, Louisiana, 71130

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

About this study

Official title: A Randomized Phase II Open Label Study to Assess the Efficacy & Safety of Gemcitabine + Abraxane® With or Without ODSH (2-0, 3-0 Desulfated Heparin) as First Line Treatment of Metastatic Pancreatic Cancer

This randomized, Phase 2, open label study aims to assess the efficacy and safety of gemcitabine + nab paclitaxel with or without dociparstat (ODSH) as first line treatment of metastatic pancreatic cancer. This study consists of 2 periods: a Run-in Period and a Randomized Period.

Read the detailed description

Dociparstat (ODSH) has demonstrated in vitro and in vivo inhibitory activity on mechanisms that are believed to play important roles in pancreatic cancer invasion, metastasis, and resistance to chemotherapy and radiation. Pancreatic cancer appears to have a dependence on autophagy, a regulated catabolic pathway to degrade and recycle cellular organelles and macromolecules. Autophagy appears to be largely driven by the binding of high mobility group box-1 protein (HMGB1) to the receptor for advanced glycation end-products (RAGE), which is strongly inhibited by dociparstat. Autophagy appears to not only assist pancreatic cancer cells to survive in a hypoxic, relatively avascular environment, but also appears to play an important role in chemotherapy resistance. Other important biological activities promoting pancreatic cancer invasion and metastasis affected by dociparstat include the inhibition of heparanase and the binding of tumor cells to endothelium and platelets mediated by the selectins. It is believed that these biological activities such as the inhibition of RAGE, heparanase, and selectin-mediated metastasis, can be inhibited by dociparstat at dose levels that can safely be administered without clinically significant anticoagulation.

The standard of care of pancreatic cancer is evolving. It appears that 2 combination regimens, the "FOLFIRINOX" regimen (a combination of 5-fluorouracil, leucovorin, irinotecan and oxaliplatin) and the combination of gemcitabine + nab-paclitaxel, could have more activity than the previous standard treatment of gemcitabine alone.

Patients with advanced metastatic pancreatic cancer who have not received chemotherapy, surgical or radiation treatments and have a good performance status are eligible to participate in this study. This study consists of 2 periods: a Run-in Period and a Randomized Period. In total, 10 patients are planned to be enrolled in a Run-in Period to receive gemcitabine + nab-paclitaxel + dociparstat. Pharmacokinetic sampling and safety assessments are to be conducted to decide on the continuation to the Randomized Period of the study where 50 patients are planned to be randomized at a 1:1 ratio to either of the 2 study arms:

  • Arm A: Patients will receive gemcitabine + nab-paclitaxel + dociparstat
  • Arm B: Patients will receive gemcitabine + nab-paclitaxel

The primary endpoint of this study is mean progression free survival. The secondary endpoints of this study are to consist of tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, overall survival at the end of the study, and changes from baseline for carbohydrate antigen (CA) 19-9 marker, weight, and plasma albumin.

Being tested
Nab paclitaxel, Gemcitabine, Dociparstat
Keywords
Pancreatic Cancer
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 Abraxane

    Nab-paclitaxel 125 mg/m2 will be administered IV over 30 minutes. Nab-paclitaxel will be administered weekly for 3 weeks followed by 1 week of rest (28-day cycle).

  • GemcitabineDrug

    Following the completion of nab-paclitaxel administration, gemcitabine IV infusion at 1000 mg/m2 will be administered over 30 minutes. Gemcitabine will be administered weekly for 3 weeks followed by 1 week of rest (28-cycle).

  • DociparstatDrug

    Also called ODSH, 2-O, 3-O Desulfated Heparin, Dociparstat sodium

    Following the completion of gemcitabine administration, dociparstat IV bolus at 4 mg/kg will be administered in 5 minutes immediately after completion of gemcitabine administration. Immediately following the dociparstat IV bolus administration, dociparstat 48-hour IV continuous infusion at 0.375 mg/kg/hr will be administered.

Study groups in NCT01461915
Study groupRoleWhat they receive
Run-inExperimentalDuring the Run-In Period, patients will receive gemcitabine + nab-paclitaxel + dociparstat to assess the compatibility of the combination. • Nab-paclitaxel + gemcitabine + dociparstat: * Nab-paclitaxel 125 mg/m2 will be administered intravenously (IV) over 30 minutes followed by the administration of gemcitabine IV infusion at 1000 mg/m2 over 30 minutes. Nab paclitaxel + gemcitabine will be administered weekly for 3 weeks followed by 1 week of rest (28-day cycle). * Dociparstat IV bolus at 4 mg/kg will be administered in 5 minutes immediately following the completion of gemcitabine administration. * Dociparstat 48-hour IV continuous infusion at 0.375 mg/kg/hr will be administered immediately following the dociparstat IV bolus administration.
Receives: Drug: Nab paclitaxel; Drug: Gemcitabine; Drug: Dociparstat
Arm AExperimentalPatients randomized to Arm A will receive gemcitabine + nab-paclitaxel + dociparstat. • Nab-paclitaxel + gemcitabine + dociparstat: * Nab-paclitaxel 125 mg/m2 will be administered IV over 30 minutes followed by the administration of gemcitabine IV infusion at 1000 mg/m2 over 30 minutes. Nab paclitaxel + gemcitabine will be administered weekly for 3 weeks followed by 1 week of rest (28-day cycle). * Dociparstat IV bolus at 4 mg/kg will be administered in 5 minutes immediately following the completion of gemcitabine administration. * Dociparstat 48-hour IV continuous infusion at 0.375 mg/kg/hr will be administered immediately following the dociparstat IV bolus administration.
Receives: Drug: Nab paclitaxel; Drug: Gemcitabine; Drug: Dociparstat
Arm BActive comparatorPatients randomized to Arm B will receive gemcitabine + nab-paclitaxel. • Nab-paclitaxel + gemcitabine: o Nab-paclitaxel 125 mg/m2 will be administered IV over 30 minutes followed by the administration of gemcitabine IV infusion at 1000 mg/m2 over 30 minutes. Nab paclitaxel + gemcitabine will be administered weekly for 3 weeks followed by 1 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. Number of Patients who Achieved Progression-Free Survival

    The primary objective of this study is to evaluate progression-free survival (PFS) according to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines Version 1.1. This will be assessed from Baseline to disease progression or death (whichever occurred first), for up to 9 months.

    Measured: 9 months

Secondary outcomes (1)

  1. Proportion of Patients who Achieved Overall Survival

    A secondary objective of this study is to evaluate overall survival at the End of the Study.

    Measured: 9 months

Timeline

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

  1. First posted28 Oct 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionDec 2012
  4. Study completionJun 2015

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01461915
Sponsor's protocol ID
PGX-ODSH-2011-PC1
Acronym
PGPC1
Status last verified
Jun 2022
First submitted
13 Oct 2011
Last updated
6 Jun 2022
Results posted
No

Publications

  • Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011 Dec 1;29(34):4548-54. doi: 10.1200/JCO.2011.36.5742. Epub 2011 Oct 3.

    PubMed 21969517

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nab paclitaxel, Gemcitabine and Dociparstat in people with Metastatic Pancreatic Cancer, run by Jazz Pharmaceuticals at 16 sites in United States.

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 12 inclusion and 13 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: stopped early, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. 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?

The study was stopped early. Results are not available in the source record.

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?

Number of Patients who Achieved Progression-Free Survival (time frame: 9 months). 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 NCT01461915, which also lists 1 linked publication.

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 6 Jun 2022.

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