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AZD2014 and Weekly Paclitaxel in Squamous NSCLC

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: NCT02403895
Recruitment Status : Terminated
First Posted : March 31, 2015
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Squamous Non Small Cell Lung Cancer
Interventions Drug: Open-label AZD2014
Drug: paclitaxel
Enrollment 11
Recruitment Details First subject enrolled: 15 April 2015 Last subject last visit: 29 December 2016 The study was performed at 7 centres: 4 USA, 2 Spain, 1 Germany Patient population: Patients with squamous non-small cell lung cancer with relapsed or refractory disease for whom weekly paclitaxel is an appropriate treatment choice
Pre-assignment Details 11 patients were enrolled Patients were assigned to treatment if they met all of the inclusion criteria and none of the exclusion criteria.
Arm/Group Title Open-label AZD2014
Hide Arm/Group Description Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Open-label AZD2014
Hide Arm/Group Description Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  72.7%
>=65 years
3
  27.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
1
   9.1%
Male
10
  90.9%
1.Primary Outcome
Title Percentage of Patients Who Have a Partial Response or Complete Response Through Measurement of Tumour Lesion Sizes
Hide Description Calculation of the percentage of patient who have a Complete Response or Partial Response to treatment which is confirmed by a repeat assessment 4 weeks later
Time Frame From first dose until disease progression (Approximately 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Set: Evaluable for efficacy set. All dosed patients with a baseline tumour assessment
Arm/Group Title Open-label AZD2014
Hide Arm/Group Description:
Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
Overall Number of Participants Analyzed 11
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage
Complete Response (CR)
0
(0 to 23.8)
Partial Response (PR)
0
(0 to 23.8)
2.Secondary Outcome
Title Number of Patients Who Experienced at Least One Adverse Event (AE) or Serious Adverse Event (SAE)
Hide Description

The safety and tolerability of AZD2014 with weekly paclitaxel as assessed with the collection of Adverse Events and Serious Adverse Events as reported during clinic visits. In addition, clinical assessments were made throughout the on treatment period including blood test for chemistry, haematology, and blood clotting. In addition to clinical observations such as vital signs, and cardiac function through the use of ECG.

Any findings from the above assessments which were considered to be abnornal and clinically significant by the doctor were reported as (AEs or SAEs).
Time Frame Informed consent until end of safety follow up (Approx 10 months if all treatment cycles are completed)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-label AZD2014
Hide Arm/Group Description:
Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Count of Participants
Adverse Event (AE) 11
Serious Adverse Event (SAE) 4
3.Secondary Outcome
Title Overall Survival: Median Number of Days Between the First Dose and End of Life Due to Any Cause
Hide Description Assessment of the duration of overall survival in weeks through direct patient follow-up. Any patient not known to have died at the time of analysis censored at the last recorded date the patient was known to be alive
Time Frame From first dose until end of life (Approx 9 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-label AZD2014
Hide Arm/Group Description:
Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: Days
104
(27 to 164)
4.Secondary Outcome
Title Best Objective Response: Number of Patients Who Experienced a Best Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not-Evaluable (NE), Through Measurement of Tumour Lesion Sizes.
Hide Description Per Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed through imaging (CT or MRI scan) or clinical examination; Complete Response (CR): Disappearance of all target lesions; Partial Response (PR) >=30% decrease in sum of target lesion longest diameter; Progressive Disease >=20% increase in sum of target lesion longest diameter; Stable Disease (SD) increase or decrease amounting to neither PR or PD. Overall tumour assessment based on quantitative assessment of target lesions and qualitative assessment of non-target lesions in line with RECIST criteria.
Time Frame From Baseline until Disease Progression (Approx 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-label AZD2014
Hide Arm/Group Description:
Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Count of Participants
PD 6
SD 5
PR 0
CR 0
5.Secondary Outcome
Title Duration of Response: Median Number of Days From the Date of First Documented Response Until the Date of Documented Progression Through Measurement of Tumour Lesion Sizes
Hide Description Assessment of the duration of tumour response through assessment of tumour lesions by RECIST 1.1 criteria. Response is defined as the point at which the criteria for Partial Response (PR) was met) >=30% decrease in sum of target lesion longest diameter. Progression is defined as the point at which the criteria for Progressive Disease (PD) was met >=20% increase in sum of target lesion longest diameter, or until end of life.
Time Frame From date of first documented response until documented progression or end of life in the absence of progression (Approx 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
No participant responded therefore no duration of response data to report
Arm/Group Title Open-label AZD2014
Hide Arm/Group Description:
Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Disease Control Rate: Percentage of Patients Who Achieve Partial Response, Complete Response or Stable Disease Through Assessment of Tumour Lesion Sizes
Hide Description Assessment of the disease control rate, percentage of patients who experience a response through assessment of tumour lesions by RECIST 1.1 criteria
Time Frame From first dose until documented progression and at least 6 weeks after the start of treatment for assessment of Stable Disease - Assessed at 6, 13 and 20 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-label AZD2014
Hide Arm/Group Description:
Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
Overall Number of Participants Analyzed 11
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: Percentage of patients
Disease Control Rate at 6 Weeks
45.5
(24.1 to 68.2)
Disease Control Rate at 13 Weeks
18.2
(4.9 to 41.5)
Disease Control Rate at 20 Weeks
18.2
(4.9 to 41.5)
7.Secondary Outcome
Title Change in Tumour Size: Median Percentage Change in Tumour Size in mm by Measurement of Tumour Lesion Sizes
Hide Description Assessment of the degree of tumour response through measurement of the change in tumour lesion sizes
Time Frame From baseline until documented progression (Approx 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-label AZD2014
Hide Arm/Group Description:
Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: % change
0.0
(-33.3 to 41.8)
8.Secondary Outcome
Title Progression Free Survival: Median Number of Days Between Start of Dosing Until Objective Disease Progression Through Measurement of Tumour Lesion Sizes
Hide Description Assessment of the duration of progression free survival through assessment of tumour lesions by RECIST 1.1 criteria
Time Frame From date of first dose until documented progression or end of life (Approx 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-label AZD2014
Hide Arm/Group Description:
Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: Days
91
(15 to 98)
9.Secondary Outcome
Title Evaluate the Effect of the Combination of AZD2014 and Paclitaxel on Pharmacokinetics Assessment of Cmax
Hide Description To determine the effect of co-administration of paclitaxel on the PK of oral AZD2014 and the effect of co administration of oral AZD2014 on the PK of paclitaxel (Group A) by: PK parameters for each in the presence and absence of the other by intensive PK sampling and NCA techniques.
Time Frame Assessment at multiple timepoints in Group A patients. Samples will be taken at pre-dose and at 10 further timepoints on day 1 and at pre-dose and 9 further timepoints on days 3 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Data insufficient for full PK parameter evaluation or comparisons made between AZD2014 and paclitaxel
Arm/Group Title Open-label AZD2014
Hide Arm/Group Description:
Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
Overall Number of Participants Analyzed 2
Mean (Full Range)
Unit of Measure: ng/mL
Paclitaxel Cmax
2240
(1500 to 2980)
AZD2014 Cmax
1021
(741 to 1300)
10.Secondary Outcome
Title Estimated Pharmacokinetic Exposure to AZD2014 Through the Use of Population PK Modelling
Hide Description Group B patients: PK parameters for AZD2014 estimated from a sparse PK sampling regimen and use of population PK modelling techniques (may be reported outside the clinical study report (CSR))
Time Frame Assessment at multiple timepoints in Group B patients between study day 1 and day 3. Samples will be taken at 3 points on day 1 and at predose and at a further 2 points on day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The exposure of AZD2014 could not be estimated using a population PK model because there were insufficient subjects with intensive PK sampling (n=2) to develop at population PK model
Arm/Group Title Open-label AZD2014
Hide Arm/Group Description:
Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse Events were collected from the time of informed consent throughout the treatment period until the end of the follow-up period. The follow-up period if defined as 28 days after study treatment is discontinued for a given patient. Total duration of collection period = approximately 10 months if all cycles and follow-up period is completed.
Adverse Event Reporting Description Adverse events were assessed systematically through clinical review, and collection of laboratory assessment, physical examination, performance status, ECHO/MUGA and ECG. Patients attended the clinic for assessment on a weekly basis
 
Arm/Group Title Open-label AZD2014
Hide Arm/Group Description Open-label AZD2014 given twice daily 3 days on, 4 days off during weekly paclitaxel
All-Cause Mortality
Open-label AZD2014
Affected / at Risk (%)
Total   9/11 (81.82%) 
Hide Serious Adverse Events
Open-label AZD2014
Affected / at Risk (%)
Total   4/11 (36.36%) 
Blood and lymphatic system disorders   
Anaemia † 1  1/11 (9.09%) 
Infections and infestations   
Cellulitis † 1  1/11 (9.09%) 
Pneumonia † 1  1/11 (9.09%) 
Nervous system disorders   
Seizure † 1  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders   
Acute Respiratory Failure † 1  1/11 (9.09%) 
Pulmonary Embolism † 1  1/11 (9.09%) 
Vascular disorders   
Deep vein thrombosis † 1  1/11 (9.09%) 
1
Term from vocabulary, MedDRA 18.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-label AZD2014
Affected / at Risk (%)
Total   11/11 (100.00%) 
Blood and lymphatic system disorders   
Anaemia † 1  3/11 (27.27%) 
Leukopenia † 1  1/11 (9.09%) 
Gastrointestinal disorders   
Abdominal Pain † 1  2/11 (18.18%) 
Abdominal distension † 1  1/11 (9.09%) 
Constipation † 1  1/11 (9.09%) 
Diarrhoea † 1  1/11 (9.09%) 
Dyspepsia † 1  1/11 (9.09%) 
Stomatitis † 1  1/11 (9.09%) 
Vomiting † 1  1/11 (9.09%) 
General disorders   
Asthenia † 1  2/11 (18.18%) 
Fatigue † 1  4/11 (36.36%) 
Mucosal Inflammation † 1  1/11 (9.09%) 
Infections and infestations   
Pneumonia † 1  1/11 (9.09%) 
Fungal Infection † 1  1/11 (9.09%) 
Lower Respiratory Tract Infection † 1  1/11 (9.09%) 
Nasopharyngitis † 1  1/11 (9.09%) 
Upper Respiratory Tract Infection † 1  1/11 (9.09%) 
Injury, poisoning and procedural complications   
Infusion related reaction † 1  1/11 (9.09%) 
Spinal compression fracture † 1  1/11 (9.09%) 
Investigations   
Weight decreased † 1  1/11 (9.09%) 
Metabolism and nutrition disorders   
Decreased Appetite † 1  1/11 (9.09%) 
Hypercalcaemia † 1  1/11 (9.09%) 
Hyperglycaemia † 1  1/11 (9.09%) 
Hypoalbuminaemia † 1  1/11 (9.09%) 
Hypokalaemia † 1  1/11 (9.09%) 
Hypomagnesaemia † 1  1/11 (9.09%) 
Hyponatraemia † 1  1/11 (9.09%) 
Increased appetite † 1  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  1/11 (9.09%) 
Bone pain † 1  1/11 (9.09%) 
Spinal Column Stenosis † 1  1/11 (9.09%) 
Nervous system disorders   
Neuropathy Peripheral † 1  3/11 (27.27%) 
Headache † 1  1/11 (9.09%) 
Nerve compression † 1  1/11 (9.09%) 
Psychiatric disorders   
Depression † 1  1/11 (9.09%) 
Eating disorder symptom † 1  1/11 (9.09%) 
Insomnia † 1  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1  4/11 (36.36%) 
Dyspnoea † 1  2/11 (18.18%) 
Pulmonary Embolism † 1  1/11 (9.09%) 
Dyspnoea Exertional † 1  1/11 (9.09%) 
Haemoptysis † 1  1/11 (9.09%) 
Hypoxia † 1  1/11 (9.09%) 
Nasal dryness † 1  1/11 (9.09%) 
Skin and subcutaneous tissue disorders   
Dry Skin † 1  1/11 (9.09%) 
Papule † 1  1/11 (9.09%) 
Pruritus † 1  1/11 (9.09%) 
Rash † 1  1/11 (9.09%) 
1
Term from vocabulary, MedDRA 18.1
†
Indicates events were collected by systematic assessment
Sponsor and Investigator decision was taken to terminate further recruitment into the study due to lack of observed responses rendering it futile to continue. As such, an abbreviated Clinical Study Report was produced based on data from 11 patients.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Science Director
Organization: AstraZeneca
EMail: clinicaltrialtransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02403895    
Other Study ID Numbers: D2274C00001
First Submitted: March 7, 2015
First Posted: March 31, 2015
Results First Submitted: December 22, 2017
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018