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A Phase Ib/II, Open-label Study of LJM716 in Combination With BYL719 Compared to Taxane or Irinotecan in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Squamous Cell Carcinoma

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Trial Information

A Phase Ib/II, Open-label Study of LJM716 in Combination With BYL719 Compared to Taxane or Irinotecan in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)


Inclusion Criteria:



- Histologically confirmed esophageal squamous cell carcinoma (ESCC)

- No more than one prior chemotherapy regimen for recurrent or metastatic ESCC (for
Phase II only).

- Progression during or after platinum-based therapy for recurrent or metastatic ESCC,
or recurrence within 6 months of platinum-based chemotherapy or chemoradiotherapy for
localized disease.

Exclusion Criteria:

- Patients who received prior phosphoinositide-3-kinase (PI3K) inhibitor or
anti-receptor tyrosine-protein kinase erbB-3 (ERBB3 or HER3) antibody treatment,
including bi-specific antibodies with HER3 as one of the targets (patients with prior
exposure to pertuzumab or epidermal growth factor receptor (EGFR)-targeted agents are
eligible)

- Patients who do not have an archival or fresh tumor sample (or sections of it)
available or readily obtainable.

- Patients with central nervous system (CNS) metastatic involvement.

- Patients who have received prior systemic anti-cancer treatment, such as cyclical
chemotherapy or biological therapy within a period of time that is shorter than the
cycle length used for that treatment (e.g. 6 weeks for nitrosourea, mitomycin-C)
prior to starting study treatment.

- Patients who have received definitive radiotherapy ≤ 4 weeks prior to starting study
drug, who have not recovered from side effects of such therapy and/or from whom ≥ 30%
of the bone marrow was irradiated.

- Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase Ib primary outcome measure: Incidence rate of dose limiting toxicities (DLTs).

Outcome Description:

The open-label dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose(s) and/or Recommended Phase II Dose (s) guided by the safety (incidence of dose limiting toxicities), efficacy, pharmacokinetics and pharmacodynamics data.

Outcome Time Frame:

approximately 8 months

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLJM716X2103

NCT ID:

NCT01822613

Start Date:

June 2013

Completion Date:

August 2016

Related Keywords:

  • Esophageal Squamous Cell Carcinoma
  • esophageal cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases

Name

Location

MD Anderson Cancer Center/University of Texas Gastrointestinal Med. OncologyHouston, Texas  77030-4009
University of Chicago Medical Center Dept of OncChicago, Illinois  60546
Wayne State University/Karmanos Cancer Institute Dept of OncDetroit, Michigan  48201