clinical research study to find out if buparlisib (BKM120) in combination with docetaxel therapy is safe and has beneficial effects in people who have advanced or metastatic squamous non-small cell lung cancer and were previously treated with platinum-based chemotherapy.

Phase 1

• Conditions: advanced/metastatic squamous non small cell lung cancer; MedDRA version: 14.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); 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); MedDRA version: 14.1Level: PTClassification code 10001254Term: Adenosquamous cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10001253Term: Adenosquamous cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000833-11-GB
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-30
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

•Patient is an adult = 18 years old at the time of informed consent
•Patient has histologically and/or cytologically confirmed diagnosis of squamous NSCLC. Diagnosis of mixed squamous and non-squamous or adenosquamous NSCLC will be acceptable for enrollment.
•Patient has received one prior approved regimen of platinum-based chemotherapy (excluding a docetaxel-containing regimen) for advanced or metastatic (Stage IIIb or Stage IV) squamous NSCLC, followed by disease progression. A drug provided as maintenance therapy following cytotoxic chemotherapy will be considered to be part of that regimen.
Note: Patients who received paclitaxel therapy are eligible for this trial.
•Patient has adequate tumor tissue (either archival or new tumor biopsy) for the analysis of PI3K-related biomarkers.
- Enrollment in the Phase II part of the study is contingent on the central laboratory confirming receipt of an adequate amount of tissue including sufficient DNA for analysis.
•Patient has measurable or non-measurable disease according to RECIST version 1.1 criteria.
- Phase II only: Patient must have at least one measurable lesion as per RECIST criteria.
•Patient has an ECOG performance status = 1
•Patient has 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

•Patient has received previous treatment with a PI3K or AKT inhibitor
•Patient has symptomatic Central Nervous System (CNS) metastases
- Patients with asymptomatic CNS metastases may participate in this trial. The patient must have completed prior local treatment, if any, for CNS metastases = 28 days prior to the start of study treatment (including radiotherapy and/or surgery, or = 14 days for stereotactic radiosurgery).
•Patient has a score = 12 on the PHQ-9 questionnaire.
•Patient selects a response of 1, 2 or 3” to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9).
•Patient has a GAD-7 mood scale score = 15.
•Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation or patients with active severe personality disorders.
•Patient has = CTCAE grade 3 anxiety

Study & Design

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