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A Dose-finding Phase Ib Study Followed by a Randomized, Double-blind Phase II Study of Carboplatin and Paclitaxel With or Without Buparlisib in Patients With Previously Untreated Metastatic Non-small Cell Lung Cancer (NSCLC) of Squamous Histology


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Non-Small Cell Lunch Cancer

Thank you

Trial Information

A Dose-finding Phase Ib Study Followed by a Randomized, Double-blind Phase II Study of Carboplatin and Paclitaxel With or Without Buparlisib in Patients With Previously Untreated Metastatic Non-small Cell Lung Cancer (NSCLC) of Squamous Histology


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

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)

Outcome Description:

Determine the MTD and/or RP2D of daily buparlisib in combination with paclitaxel and carboplatin in patients with advanced or metastatic squamous NSCLC.

Outcome Time Frame:

Cycle 1 (21 days)

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBKM120D2204

NCT ID:

NCT01820325

Start Date:

June 2013

Completion Date:

October 2016

Related Keywords:

  • Non-Small Cell Lunch Cancer
  • Squamous non-small cell lung cancer, NSCLC, stage IIIb with malignant effusion, stage IV
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Reliant Medical Group Reliant Medical GroupWorchester, Massachusetts  01608