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Clinical Trial 19602

Cancer Type: Gastrointestinal Tumor
Interventions:Gemzar (gemcitabine); Nab-paclitaxel (Abraxane); Olaratumab; Placebo; gemcitabine

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Dae Won Kim

Call 813-745-6100
or 1-800-679-0775
Overview

Study 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

Summary

Objective

Objectives Endpoints Primary Phase 1b: to determine a recommended Phase 2 dose of olaratumab in combination with nab-paclitaxel and gemcitabine Phase 2: to compare the efficacy of olaratumab plus nabpaclitaxel and gemcitabine with placebo plus gemcitabine and nab-paclitaxel Phase 1b: DLTs - Safety (including but not limited to) TEAEs, SAEs, and clinical laboratory abnormalities Phase 2 OS Secondary Phase 1b to characterize the safety and toxicity profile of olaratumab plus nab-paclitaxel and gemcitabine Phase 1b Safety monitoring, including TEAEs, SAE, and deaths to evaluate the PK and immunogenicity of olaratumab plus nab-paclitaxel and gemcitabine to document the antitumor activity observed with olaratumab plus nab-paclitaxel and gemcitabine Minimum serum/plasma concentration of olaratumab plus nab-paclitaxel and gemcitabine Anti-drug antibody concentration OS, PFS, DoR, ORR Phase 2 to assess time-to-event variables Phase 2 PFS, DoR to document the antitumor activity observed with olaratumab plus nab-paclitaxel and gemcitabine ORR to assess the following PROs: h mBPI-sf, EORTC-QLQ-C30, and EQ-5D-5L to determine safety and tolerability of olaratumab in combination with nab-paclitaxel and gemcitabine TEAEs, AESIs, SAEs, clinical laboratory tests, vital signs, physical examinations, hospitalizations, and death to assess the PK and immunogenicity of olaratumab plus nab-paclitaxel and gemcitabine. Minimum serum/plasma concentration of olaratumab plus nab-paclitaxel and gemcitabine Anti-drug antibody concentration Tertiary/Exploratory to characterize tumor tissue and blood biomarkers relevant to study drugs including but not limited to immune cells/immune and tumor microenvironment functioning, mechanism of action of study drugs, cancer-related pathways, and disease state to assess the relationship between biomarkers and clinical outcomes Markers of immune function, tumor microenvironment, drug targets, signaling pathways, and disease status

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 > 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.