Safety and efficacy of BKM120 in patients with metastatic non-small cell lung cancer
- Conditions
- Adult patients with metastatic NSCLC with activated PI3K pathway.MedDRA version: 14.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-024011-14-NL
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
1. Histologically confirmed NSCLC with activated PI3K pathway
2. Progressive disease after prior systemicantineoplasic treatment(s) for advanced NSCLC
3. Archival or fresh tumor biopsy must be available for
4. Measurable and/or non-measurable disease as per RECIST 1.1 criteria
(Appendix 8)
5. Eastern Cooperative Oncology Group (ECOG) performance status = 2
6. Adequate organ function as assessed by laboratory tests
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
1. Patient has received previous treatment with PI3K inhibitors
2. Patient with squamous NSCLC has received more than one line of chemotherapy treatment for metastatic disease; patient with non-squamous NSCLC has received more than two lines of systemic antineoplastic treatment for metastatic disease
3. Uncontrolled or symptomatic CNS metastases
4. Concurrent use of any other approved or investigational antineoplastic agent
5. Radiotherapy = 28 days prior to starting study drug
6. Major surgery within 28 days prior to starting study drug
7. History of clinically significant cardiac dysfunction, mood disordre, or poorly controlled diabetes mellitus
8. Current treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes
9. Impairment of gastrointestinal (GI) function
10. Chronic treatment with steroids or another immunosuppressive agent.
11. Concurrent severe and/or uncontrolled medical condition
12. Currently receiving Warfarin or another coumarin derivative
13. Known history of HIV infection
14. Sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
15. Pregnancy, lactation, or breastfeeding, woman of child-bearing potential
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Progression Free Survival (PFS) as measured using RECIST 1.1;Secondary Objective: To determine Objective Response Rate (ORR)<br>To determine Time to Response (TTR)<br>To determine Duration of Response<br>To determine Overall Survival (OS)<br>To characterize the Safety as measured by frequency and severity of AEs and lab values;Primary end point(s): PFS per RECIST 1.1<br>;Timepoint(s) of evaluation of this end point: 12 week PFS rate (patients who progressed, died or discontinued before 12 weeks of observation are counted as failure; other cases are reported as success)<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Objective Response Rate (ORR) per RECIST<br>2.Time to Response (TTR)<br>3.Overall Survival (OS)<br>4. Frequency and severity of adverse events<br>5. Lab values : worst grade based on the Common Terminology Criteria of Adverse Events (CTCAE version 4.0);Timepoint(s) of evaluation of this end point: FAS (Full analysis set) unless otherwise specified