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A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03086369
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: Olaratumab Drug: Nab-paclitaxel Drug: Gemcitabine Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer
Actual Study Start Date : June 22, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : November 30, 2021


Arm Intervention/treatment
Experimental: Olaratumab + Nab-paclitaxel + Gemcitabine (Dose Escalation)
(Open Label) Olaratumab, nab-paclitaxel and gemcitabine given intravenously (IV).
Drug: Olaratumab
Administered IV
Other Name: LY3012207

Drug: Nab-paclitaxel
Administered IV

Drug: Gemcitabine
Administered IV

Experimental: Olaratumab + Nab-paclitaxel + Gemcitabine (Cohort Expansion)
(Open Label) Olaratumab, nab-paclitaxel and gemcitabine given IV.
Drug: Olaratumab
Administered IV
Other Name: LY3012207

Drug: Nab-paclitaxel
Administered IV

Drug: Gemcitabine
Administered IV

Experimental: Olaratumab + Nab-paclitaxel + Gemcitabine (Treatment)
(Double Blind) Olaratumab, nab-paclitaxel and gemcitabine given IV.
Drug: Olaratumab
Administered IV
Other Name: LY3012207

Drug: Nab-paclitaxel
Administered IV

Drug: Gemcitabine
Administered IV

Placebo Comparator: Placebo + Nab-paclitaxel + Gemcitabine
(Double Blind) Placebo, nab-paclitaxel and gemcitabine given IV.
Drug: Nab-paclitaxel
Administered IV

Drug: Gemcitabine
Administered IV

Drug: Placebo
Administered IV




Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities (DLTs) Phase 1b [ Time Frame: Cycle 1 (28 Days) ]
    Number of participants with DLTs phase 1b

  2. Overall Survival (OS) Phase 2 [ Time Frame: Baseline to Date of Death from Any Cause (Approximately 9 Months) ]
    OS phase 2


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab [ Time Frame: Baseline through End of Study (Approximately 9 Months) ]
    PK: Cmin of olaratumab

  2. Number of Participants with Anti-Olaratumab Antibodies [ Time Frame: Baseline through End of Study (Approximately 9 Months) ]
    Number of participants with anti-olaratumab antibodies

  3. OS Phase 1b [ Time Frame: Baseline to Date of Death from Any Cause (Approximately 9 Months) ]
    OS phase 1b

  4. Progression-Free Survival (PFS) [ Time Frame: Baseline to Disease Progression or Death (Approximately 6 Months) ]
    PFS

  5. Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Disease Progression or Death (Approximately 6 Months) ]
    ORR: Percentage of participants who achieve CR or PR

  6. Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 5.5 Months) ]
    DoR

  7. Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" [ Time Frame: Baseline through Follow-up (Approximately 9 Months) ]
    Time to first worsening of the mBPI-sf "worst pain score"

  8. Time to Sustained Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scale Scores [ Time Frame: Baseline through Follow-up (Approximately 9 Months) ]
    Time to sustained worsening of symptom burden on the EORTC QLQ-C30 scale scores

  9. Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L) [ Time Frame: Baseline through Follow-up (Approximately 9 Months) ]
    Health status on the EQ-5D-5L



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological diagnosis of adenocarcinoma of the exocrine pancreas that is metastatic (Stage IV) and not amenable to resection with curative intent.
  • If present, clinically significant or symptomatic amounts of ascites should be drained prior to Day 1.
  • Have had no prior systemic treatment for metastatic disease. Prior adjuvant or neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed if completed ≥3 months prior to enrollment and no lingering toxicities are present.
  • Prior radiation therapy for treatment of cancer is allowed to <25% of the bone marrow.
  • Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy.
  • Measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Discontinued all previous treatments for cancer ≥4 weeks prior.
  • Adequate organ function.
  • Life expectancy of at least 3 months.

Exclusion Criteria:

  • Serious concomitant systemic disorder.
  • Have received first line treatment for metastatic pancreatic cancer.
  • Received prior treatment with nab-paclitaxel.
  • Have known central nervous system malignancy or metastasis.
  • Current hematologic malignancies.
  • Participated within the last 30 days in a clinical trial involving an investigational product.
  • Women with a positive pregnancy test or lactating.
  • Have endocrine pancreatic tumors or ampullary cancer.
  • Currently enrolled in another clinical trial.
  • Have a known additional malignancy that is progressing or required active treatment within the past 1 year.
  • Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug formulations.
  • Are taking certain anti-coagulant medications such as warfarin and are unable to be switched to other similar medicines.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086369


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

  Show 35 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03086369     History of Changes
Other Study ID Numbers: 15844
I5B-MC-JGDP ( Other Identifier: Eli Lilly and Company )
2016-001099-31 ( EudraCT Number )
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Olaratumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs