Study of safety & efficacy of the combination of LJM716 & BYL719 in patients with previously treated esophageal squamous cell carcinoma (ESCC)

Phase 1

• Conditions: esophageal squamous cell carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005624-15-ES
• Lead Sponsor: ovartis Farmacéutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-16
• Last Update Posted: 20 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- Histologically confirmed 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 platinumbased chemotherapy or chemoradiotherapy for localized disease.
Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

- Patients who received prior PI3K inhibitor or anti-HER3 antibody treatment, including bi-specific antibodies with HER3 as one of the targets (patients with prior exposure to pertuzumab or 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 sytem (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 exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified