Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
Study NCT ID:
NCT04010357
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2019-07-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Targeted Therapy With CDK4/6 Inhibitors in Chemo-Refractory, Rb Wild-Type Extensive SCLC
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Targeted Therapy With CDK4/6 Inhibitors in Chemo- Refractory/Relapsed, Rb Wild-type Extensive Small Cell Lung Cancer (SCLC), Large Cell Neuroendocrine Lung Cancer, Extrapulmonary Small Cell Cancers and Other High Grade Neuroendocrine Cancers of the Lung, an Open Label Phase 2 Trial.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to:
* Test how well the study medicine Abemaciclib, a CDK4/6 inhibitor, works to shrink lung cancer tumors in the body.
* Test the safety of Abemaciclib when given to participants with small cell lung cancer (SCLC), large cell neuroendocrine lung cancer, extrapulmonary small cell cancers and other high grade neuroendocrine cancers of the lung. Specifically, this study is looking at SCLC, large cell neuroendocrine lung cancer, extrapulmonary small cell cancers and other high grade neuroendocrine cancers of the lung that have not responded to treatment (refractory) or come back after treatment with chemotherapy (relapsed) as the study medication has been shown to be effective any time the disease relapses not just in the first few months.
* Test how well the study medicine Abemaciclib, a CDK4/6 inhibitor, works to shrink lung cancer tumors in the body.
* Test the safety of Abemaciclib when given to participants with small cell lung cancer (SCLC), large cell neuroendocrine lung cancer, extrapulmonary small cell cancers and other high grade neuroendocrine cancers of the lung. Specifically, this study is looking at SCLC, large cell neuroendocrine lung cancer, extrapulmonary small cell cancers and other high grade neuroendocrine cancers of the lung that have not responded to treatment (refractory) or come back after treatment with chemotherapy (relapsed) as the study medication has been shown to be effective any time the disease relapses not just in the first few months.
Detailed Description:
This is a multicenter, non-randomized, phase 2, single arm study to determine the efficacy and safety of Abemaciclib as a single agent in patients with biopsy-proven wild type Rb extensive stage of SCLC, with platinum refractory disease (defined as no response after 1-2 cycles of chemotherapy or relapse defined as initial response but relapse after completing platinum-based chemotherapy). Subjects with other tumor types with biopsy proven wild type Rb such as large cell neuroendocrine lung cancer, extrapulmonary small cell cancers and other high grade neuroendocrine cancers of the lung may also be enrolled.
Abemaciclib (CDK4/6 inhibitors) is an investigational drug that works by interrupting the rapid and uncontrolled growth of cancer cells. Some cancer cells develop because their cells overrun the molecular brakes that normally permit cell to divide only when they are needed to replace old ones. These brakes are regulated by a group of enzymes known as cyclin-dependent kinases (CDKs). Alterations causing over-activity of two of these enzymes, CDK4 and CDK6, are found in a variety of cancers, including small cell lung cancer with retinoblastoma (Rb) protein. The drugs work by selectively turning off the overactive CDK4 and CDK6. As a result, the cancer cells' division cycle is halted, preventing them from proliferating.
The objectives of this study include determining:
* Overall Response Rate (ORR) after the first cycle (4 weeks) and then every 8 weeks.
* Progression Free Survival (PFS)assessed at 6 months and Overall Survival (OS).
* Safety and adverse events
* Duration of response in all responders
Abemaciclib (CDK4/6 inhibitors) is an investigational drug that works by interrupting the rapid and uncontrolled growth of cancer cells. Some cancer cells develop because their cells overrun the molecular brakes that normally permit cell to divide only when they are needed to replace old ones. These brakes are regulated by a group of enzymes known as cyclin-dependent kinases (CDKs). Alterations causing over-activity of two of these enzymes, CDK4 and CDK6, are found in a variety of cancers, including small cell lung cancer with retinoblastoma (Rb) protein. The drugs work by selectively turning off the overactive CDK4 and CDK6. As a result, the cancer cells' division cycle is halted, preventing them from proliferating.
The objectives of this study include determining:
* Overall Response Rate (ORR) after the first cycle (4 weeks) and then every 8 weeks.
* Progression Free Survival (PFS)assessed at 6 months and Overall Survival (OS).
* Safety and adverse events
* Duration of response in all responders
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: