Phase II Study of Buparlisib + Docetaxel in Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) Patients
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 (MTD)/Recommended Phase II Dose (RP2D) of buparlisib in combination with docetaxel. Subsequently the MTD/RP2D will be investigated in a Phase II randomized trial in patients with advanced or metastatic squamous NSCLC.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 14, 2018 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: Buparlisib; Drug: Buparlisib matching placebo; Drug: Docetaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Highlands Oncology Group SC-1Fayetteville, Arkansas
- H. Lee Moffitt Cancer Center & Research Institute H Lee MoffittTampa, Florida
- Reliant Medical Group Reliant Medical GroupWorcester, Massachusetts
- Virginia Oncology Associates Virginia Oncology Assoc. (2)Norfolk, Virginia
- Novartis Investigative SiteCharleroi
- Novartis Investigative SiteMons
- Novartis Investigative SiteCréteil
- Novartis Investigative SiteSaint-Herblain
- Novartis Investigative SiteFrankfurt
- Novartis Investigative SiteHeidelberg
- Novartis Investigative SiteMainz
- Novartis Investigative SiteMonza, MB
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 14, 2018. Always confirm current availability with the study team.