Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01822613
Phase
PHASE1
Status
Completed

Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LJM716 — DRUG
    LJM716 (10-40 mg/kg) will be given as a once weekly infusion beginning on cycle 1 day 1. The doses of LJM716 will be increased as dose escalation proceeds until a maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) is established.
  • BYL719 — DRUG
    BYL719 (200-400 mg) will be administered orally on a once daily schedule starting cycle 1 day 1. The doses of BYL719 will be increased as dose escalation proceeds until a maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) is established.
  • Paclitaxel — DRUG
    In the Phase II portion of the study Paclitaxel is one of the 3 physician's choice drug which allows single-agent paclitaxel to be used per manufacturer's label.
  • Docetaxel — DRUG
    In the Phase II portion of the study Docetaxel is one of the 3 physician's choice drug which allows single-agent docetaxel to be used per manufacturer's label.
  • Irinotecan — DRUG
    In the Phase II portion of the study Irinotecan is one of the 3 physician's choice drug which allows single-agent irinotecan to be used per manufacturer's label

Study Details

To study the safety and efficacy of the combination of LJM716 and BYL719 against currently available treatments of physician's choice in previously treated esophageal squamous cell carcinoma patients.

Key Dates

Start date
Jul 26, 2013
Status verified
May 2017
Primary completion
Jun 3, 2016
Completion
Jun 3, 2016

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LJM716-BYL719 arm
    approximately 42 previously treated esophageal squamous cell carcinoma (ESCC) patients will be enrolled to the LJM716-BYL719 combination arm to evaluate the anti-tumor activity and further assess the safety, tolerability and anti-tumor activity of the combination versus current therapies (physician's choice of paclitaxel, docetaxel or irinotecan).
  • Active Comparator: Paclitaxel, Docetaxel or Irinotecan arm
    approximately 42 previously treated esophageal squamous cell carcinoma (ESCC) patients will be enrolled to the Paclitaxel, Docetaxel or Irinotecan arm (physician's choice arm) to evaluate the anti-tumor activity and further assess the safety, tolerability and anti-tumor activity of the LJM716-BYL719 combination versus current therapies (physician's choice of paclitaxel, docetaxel or irinotecan).

Primary Outcome Measure

Phase Ib primary outcome measure: Incidence rate of dose limiting toxicities (DLTs). [ Time Frame: approximately 8 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Chicago Medical Center Dept of OncChicagoIllinois60637-
Karmanos Cancer Institute Dept of OncDetroitMichigan48201-
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. OncologyHoustonTexas77030-4009-

Find similar trials in Chicago, IL

By research site
University of Chicago Medical Center Dept of Onc· Chicago, ILKarmanos Cancer Institute Dept of Onc· Detroit, MIUniversity of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology· Houston, TX

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