An interventional study of the combination of BYL719 plus AMG 479 (ganitumab) in adult patients with selected solid tumors

Phase 1

• Conditions: Solid tumors Hormone receptor positive breast cancerOvarian cancer; MedDRA version: 17.0Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001962-13-BE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-20
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Written informed consent.
• Patients aged = 18 years (male or female).
• Patients with the following histologically/cytologically-confirmed advanced solid tumors with documented somatic PIK3CA mutations or amplifications in tumor tissue:
• Hormone receptor positive breast carcinoma
• Ovarian carcinoma
• Other tumors upon agreement with sponsor
• Adequate organ function
• Negative serum pregnancy test
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• Patients with known history of severe infusion reactions to monoclonal antibodies.
• Patients with primary CNS tumor or CNS tumor involvement.
• History of thromboembolic event requiring full-dose anti-coagulation therapy any time prior to enrollment.
• Clinically significant cardiac disease.
• History of another malignancy within last 2 years.
• Pregnant or nursing (lactating) women
Other protocol-defined exclusion criteria may apply

Study & Design

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