AZD1775 Plus Carboplatin-Paclitaxel in Squamous 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02513563|
Recruitment Status : Active, not recruiting
First Posted : July 31, 2015
Last Update Posted : February 3, 2023
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Carboplatin Drug: Paclitaxel Drug: AZD1775||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of AZD1775 Plus Carboplatin-Paclitaxel in Squamous Cell Lung Cancer|
|Actual Study Start Date :||October 30, 2015|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2023|
Treatment: Combination of AZD1775 plus carboplatin and paclitaxel. Participants will be treated with this combination of drugs twice daily on days 1 and 2 and once on day 3 for a total of 5 doses during each 21 day cycle of treatment.
Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
Other Name: Paraplatin®
Participants will be treated with paclitaxel 175 mg/m^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
Other Name: TAXOL®
Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
Other Name: MK1775
- Progression Free Survival (PFS) [ Time Frame: Up to 2 years ]PFS is measured from date of first study treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
- Overall Survival (OS) [ Time Frame: Up to 2 years ]OS is defined as the duration of time from the date for first treatment (Cycle 1 Day 1) to the date of death.
- Duration of Overall Response (OR) [ Time Frame: Up to 2 years ]The duration of overall response is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- Duration of Stable Disease (SD) [ Time Frame: Up to 2 years ]Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
- Disease Control Rates (DCR) [ Time Frame: Up to 2 years ]DCR: Complete Response (CR), Partial Response (PR), and Stable Disease (SD).
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): NCT02513563
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Jhanelle Gray, M.D.||H. Lee Moffitt Cancer Center and Research Institute|