Clinical Trials /

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

NCT03086369

Description:

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.

Related Conditions:
  • Pancreatic Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 15844
  • SECONDARY ID: I5B-MC-JGDP
  • SECONDARY ID: 2016-001099-31
  • NCT ID: NCT03086369

Conditions

  • Metastatic Pancreatic Cancer

Interventions

DrugSynonymsArms
OlaratumabLY3012207Olaratumab + Nab-paclitaxel + Gemcitabine (Dose Escalation)
Nab-paclitaxelOlaratumab + Nab-paclitaxel + Gemcitabine (Dose Escalation)
GemcitabineOlaratumab + Nab-paclitaxel + Gemcitabine (Dose Escalation)
PlaceboPlacebo + Nab-paclitaxel + Gemcitabine

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Olaratumab + Nab-paclitaxel + Gemcitabine (Dose Escalation)Experimental(Open Label) Olaratumab, nab-paclitaxel and gemcitabine given intravenously (IV).
  • Olaratumab
  • Nab-paclitaxel
  • Gemcitabine
Olaratumab + Nab-paclitaxel + Gemcitabine (Cohort Expansion)Experimental(Open Label) Olaratumab, nab-paclitaxel and gemcitabine given IV.
  • Olaratumab
  • Nab-paclitaxel
  • Gemcitabine
Olaratumab + Nab-paclitaxel + Gemcitabine (Treatment)Experimental(Double Blind) Olaratumab, nab-paclitaxel and gemcitabine given IV.
  • Olaratumab
  • Nab-paclitaxel
  • Gemcitabine
Placebo + Nab-paclitaxel + GemcitabinePlacebo Comparator(Double Blind) Placebo, nab-paclitaxel and gemcitabine given IV.
  • Nab-paclitaxel
  • Gemcitabine
  • Placebo

Eligibility 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.

          -  No prior line of systemic therapy 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.

          -  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.

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Dose Limiting Toxicities (DLTs) Phase 1b
Time Frame:Cycle 1 (28 Days)
Safety Issue:
Description:Number of participants with DLTs phase 1b

Secondary Outcome Measures

Measure:Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab
Time Frame:Baseline through End of Study (Approximately 9 Months)
Safety Issue:
Description:PK: Cmin of olaratumab
Measure:Number of Participants with Anti-Olaratumab Antibodies
Time Frame:Baseline through End of Study (Approximately 9 Months)
Safety Issue:
Description:Number of participants with anti-olaratumab antibodies
Measure:OS Phase 1b
Time Frame:Baseline to Date of Death from Any Cause (Approximately 9 Months)
Safety Issue:
Description:OS phase 1b
Measure:Progression-Free Survival (PFS)
Time Frame:Baseline to Disease Progression or Death (Approximately 6 Months)
Safety Issue:
Description:PFS
Measure: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)
Safety Issue:
Description:ORR: Percentage of participants who achieve CR or PR
Measure: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)
Safety Issue:
Description:DoR
Measure: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)
Safety Issue:
Description:Time to first worsening of the mBPI-sf "worst pain score"
Measure: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)
Safety Issue:
Description:Time to sustained worsening of symptom burden on the EORTC QLQ-C30 scale scores
Measure:Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)
Time Frame:Baseline through Follow-up (Approximately 9 Months)
Safety Issue:
Description:Health status on the EQ-5D-5L

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Eli Lilly and Company

Last Updated

January 18, 2018