BKM120 as second-line therapy in advanced endometrial cancer

Phase 1

• Conditions: Patients who have experienced progression of disease after first-line antineoplasic treatment of advanced endometrial carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022015-19-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-09
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 161

Inclusion Criteria

1.ECOG (Eastern Cooperative Oncology Group) performance status = 2
2. histologically confirmed diagnosis of advanced endometrial carcinoma
with available tissue specimen for identification of PI3K pathway
activation (archival tissue or a fixed fresh biopsy)
3. one prior line of antineoplastic treatment with a cytotoxic agent
4. objective progression of disease after prior treatment and at least one
measurable lesion as per RECIST criteria
5. adequate bone marrow and organ function
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. previous treatment with PI3K and/or mTOR inhibitors
2. symptomatic CNS metastases
3. concurrent malignancy or malignancy within 3 years of study
enrollment
4. Active mood disorder as judged by investigator or medically
documented history of mood disorder (e.g. major depressive episode,
bipolar disorder, obsessive-compulsive disorder, schizophrenia, etc.), =
CTCAE grade 3 anxiety
5. pelvic and/or para-aortic radiotherapy = 28 days prior to enrollment
in the study
6.poorly controlled diabetes mellitus (HbA1c > 8 %)
7. history of cardiac dysfunction or active cardiac disease as specified in
the protocol
8. impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of BKM120

Study & Design

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