Trial of Dose Escalated BGB324 in Previously Treated Non-small Cell Lung Cancer.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02922777|
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Carcinoma||Drug: BGB324 Drug: Docetaxel||Phase 1|
Lung cancer remains the leading cause of cancer-related deaths worldwide with an estimated incidence of 1.6 million cases resulting in 1.4 million deaths in annually. Non-small-cell lung cancer (NSCLC) represents 80-85% of cases, and adenocarcinoma is the most common histology.2 The majority of NSCLC patients present with advanced or metastatic disease that is not amenable to surgical resection. Platinum-based combination chemotherapy has reached a therapeutic plateau with a median overall survival (OS) of 7.4 to 9.9 months.
BGB324 is a potent selective small molecule inhibitor of Axl, a surface membrane protein kinase receptor that is over-expressed in many metastatic solid tumors and has been identified as a marker of a poor prognosis in patients with non-small cell lung cancer (NSCLC).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Trial of Dose Escalated BGB324 in Combination With Docetaxel for Previously Treated Advanced Non-small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
Experimental: BGB324 in combination with docetaxel
The dose of docetaxel will be 75 mg/m2 given IV every 21 days. The dose of BGB324 will be escalated in a standard 3+3 fashion until a maximum tolerated dose is determined.
75 mg/m2 every 21 days
75 mg/m2 given IV every 21 days
Other Name: Taxotere
- Determine the maximum tolerated dose of BGB324 in combination with docetaxel [ Time Frame: 42 days or 2 cycles of 21 days ]Determine and recommended the Phase 2 dose of BGB324 administered with the standard dose of docetaxel in patients in NSCLC by pharmacodynamics and pharmacokinetic assessments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922777
|Contact: Joyce Bolluyt, RNfirstname.lastname@example.org|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75063|
|Contact: Joyce Bolluyt, RN 214-648-7097 email@example.com|
|Covenant Health Systems/Joe Arrington Cancer Treatment and Research Center||Not yet recruiting|
|Lubbock, Texas, United States, 79410|
|Contact: Donald P Quick, MD 806-725-8000 firstname.lastname@example.org|
|Sub-Investigator: Donald P Quick, MD|
|Principal Investigator:||David E Gerber, MD||University of Texas Southwestern Medical Center|