Status:
TERMINATED
Phase II Study of Buparlisib + Docetaxel in Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Squamous Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a multi-center, open-label Phase Ib dose escalation part followed by a randomized double-blinded placebo controlled Phase II part. The Phase Ib part will determine the Maximum Tolerated Dose ...
Detailed Description
Based on an overall review of safety and preliminary efficacy data done on 01-Dec-2014 showing marginal anti-tumor activity and newly emerged treatment options, a decision was taken to stop further de...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01911325
Start Date
October 1 2013
End Date
August 1 2015
Last Update
August 14 2018
Active Locations (16)
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1
Highlands Oncology Group SC-1
Fayetteville, Arkansas, United States, 72703
2
H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt
Tampa, Florida, United States, 33612
3
Reliant Medical Group Reliant Medical Group
Worcester, Massachusetts, United States, 01608
4
Virginia Oncology Associates Virginia Oncology Assoc. (2)
Norfolk, Virginia, United States, 23502