A study to evaluate the potential benefit of the addition of buparlisib tostandard therapy (carboplatin and paclitaxel) in the treatment of lungcancer

Phase 1

• Conditions: 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: EUCTR2012-005541-21-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-14
• Study Completion: 2014-06-18
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

-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 archival or fresh tumor tissue for the exploratory
analysis of biomarkers related to sensitivity to PI3K
inhibitors.
- Tumor is Stage IV or Stage IIIb (with malignant pleural or pericardial
effusion) at the time of signed informed consent (UICC/AJCC version 7)
-Patient has measurable or non-measurable disease according to
RECIST v1.1 criteria (for the Phase II portion, the patient must have
measurable disease according to RECIST 1.1 criteria)
- Patient has an Eastern Cooperative Oncology
Group (ECOG) performance status = 1 that the investigator
believes is stable at the time of screening
- 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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

- Patient has received any prior systemic therapies for metastatic NSCLC.
Study treatment in this clinical trial must be the patient's first systemic
treatment for metastatic NSCLC. Patients are eligible if they received
neo-adjuvant or adjuvant systemic therapy followed by a disease-free
interval exceeding 12 months.
- Patient has symptomatic CNS metastases [patients with asymptomatic
CNS metastases may participate in this trial. The patient must have
completed any prior local treatment for CNS
metastases = 28 days prior to the start of study treatment
(including radiotherapy and/or surgery, or =14 days for
stereotactic radiosurgery)].
- Patient is currently receiving warfarin or other coumadin derived
anticoagulant for treatment, prophylaxis or otherwise. Therapy with
heparin, low molecular weight heparin (LMWH), or fondaparinux is
allowed.
- Patient is currently receiving treatment with drugs known to be
moderate or strong inhibitors or inducers of isoenzyme CYP3A. The
patient must have discontinued strong inducers for at least one week
and must have discontinued strong inhibitors before the treatment is
initiated. Switching to a different medication prior to
randomization is allowed.
- 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 (e.g. risk of doing harm to self or others) or patients
with active severe personality disorders (defined according to DSM- IV)
are not eligible. Note: for patients
with psychotropic treatments ongoing at baseline, the dose and the
schedule should not be modified within the previous 6 weeks prior to
start of study drug
- Patient has = CTCAE grade 3 anxiety
- Pregnant or nursing (lactating) women, where pregnancy is defined as
the state of a female after conception and until the termination of
gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) -
Patient who does not apply highly effective
contraception during the study and through the duration as
defined below after the final dose of study treatment.

Study & Design

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