First-line treatment for adenocarcinoma patients with Epidermal Growth Factor Receptor (EGFR) mutation

Study identifier:D7913L00056

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An open-label, Multi-centre study to evaluate efficacy and safety of Gefitinib as the first-line treatment for locally advanced (IIIB), metastatic (IV) or recurrent pulmonary adenocarcinoma patients with Epidermal Growth Factor Receptor (EGFR) mutation.

Medical condition

Pulmonary Cancer

Phase

Phase 2

Healthy volunteers

Study drug

Gefitinib

Sex

All

Actual Enrollment

Study type

Interventional

Age

19 Years +

Date

Study Start Date: 01 Mar 2006

Primary Completion Date: 01 Dec 2007

Study Completion Date: 01 Dec 2007

Study design

Allocation: Non-randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2010 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Seoul, Republic of Korea

Location

Research Site

Seongnam-Si, Republic of Korea

Arms	Assigned Interventions
Experimental: Gefitinib Gefitinib 250mg tablet once daily	Drug: Gefitinib 250mg tablet oral tablet once daily Other Name: ZD1839 Other Name: IRESSA

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
147 patients were screened for epidermal growth factor receptor (EGFR) mutation and 46 patients were enrolled in this study. Subjects were recruited by 7 investigational centers throughout South Korea from Mar 2006 to May 2007

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Gefitinib	Gefitinib 250mg tablet

Participant Flow: Overall Study

	Gefitinib
STARTED	46
COMPLETED	25
NOT COMPLETED	21
Adverse Event	2
Objective Disease Progression	16
Withdrawal by Subject	1
Not Eligible for the study	2

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Gefitinib	Gefitinib 250mg tablet

Baseline Measures

	Gefitinib
Number of Participants [units: Participants]	46
AgeContinuous [units: years] Mean ± Standard Deviation	60 ± 12
Gender, Male/Female [units: Participants]
Female	11
Male	35

Outcome Measures

1. Primary Outcome Measure: Percentage of participants who had an Objective Response Rate(ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria. [ Time Frame: baseline to 12 months ]

Measure Type	Primary
Measure Name	Percentage of participants who had an Objective Response Rate(ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
Measure Description	Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients. RECIST criteria: CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria
Time Frame	baseline to 12 months
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
Gefitinib	Gefitinib 250mg tablet

Measured Values

	Gefitinib
Number of Participants Analyzed [units:participants]	46
Percentage of participants who had an Objective Response Rate(ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria. [units: Percent of Participants]	0

No statistical analysis provided for Percentage of participants who had an Objective Response Rate(ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.

2. Secondary Outcome Measure: Progression free survival (PFS) [ Time Frame: baseline to 4 months ]

Measure Type	Secondary
Measure Name	Progression free survival (PFS)
Measure Description	Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.
Time Frame	baseline to 4 months
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
Gefitinib	Gefitinib 250mg tablet

Measured Values

	Gefitinib
Number of Participants Analyzed [units:participants]	46
Progression free survival (PFS) [units: Percent of Participants]	86.25

No statistical analysis provided for Progression free survival (PFS)

3. Secondary Outcome Measure: Overall survival (OS) [ Time Frame: baseline to 12 months ]

Measure Type	Secondary
Measure Name	Overall survival (OS)
Measure Description	Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.
Time Frame	baseline to 12 months
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
Gefitinib	Gefitinib 250mg tablet

Measured Values

	Gefitinib
Number of Participants Analyzed [units:participants]	46
Overall survival (OS) [units: Percent of Participants]	82.26

No statistical analysis provided for Overall survival (OS)

4. Secondary Outcome Measure: Safety Profile: Participants with Adverse Events [ Time Frame: baseline to end of study ]

Measure Type	Secondary
Measure Name	Safety Profile: Participants with Adverse Events
Measure Description	Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.
Time Frame	baseline to end of study
Safety Issue?	Yes

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Gefitinib	Gefitinib 250mg tablet

Serious Adverse Events

Gefitinib

Total, serious adverse events

# participants affected / at risk

4/---

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

2/---

Injury, poisoning and procedural complications

Multiple contusion with Lt.9.10.11th rib fracture¹

# participants affected / at risk

1/---

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intramuscular myxoma in the left intraspinatos muscle¹

# participants affected / at risk

1/---

Gastrointestinal disorders

Diarrhea¹

# participants affected / at risk

1/---

Nervous system disorders

Myoclonus¹

# participants affected / at risk

1/---

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
2	Term from vocabulary,

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Gefitinib	Gefitinib 250mg tablet

Other Adverse Events

Gefitinib

Total, other (not including serious) adverse events

# participants affected / at risk

44/---

Skin and subcutaneous tissue disorders

Alopecia¹,^†

# participants affected / at risk

5/---

Metabolism and nutrition disorders

Anorexia¹,^†

# participants affected / at risk

17/---

Musculoskeletal and connective tissue disorders

Back-pain¹,^†

# participants affected / at risk

4/---

Infections and infestations

Common cold¹,^†

# participants affected / at risk

3/---

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

7/---

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

13/---

Skin and subcutaneous tissue disorders

Desquamation¹,^†

# participants affected / at risk

9/---

Gastrointestinal disorders

Diarrhea¹,^†

# participants affected / at risk

16/---

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

5/---

Skin and subcutaneous tissue disorders

Dry-skin¹,^†

# participants affected / at risk

3/---

Gastrointestinal disorders

Dyspepsia¹,^†

# participants affected / at risk

4/---

Respiratory, thoracic and mediastinal disorders

Dyspnea¹,^†

# participants affected / at risk

6/---

Gastrointestinal disorders

Epigastric pain¹,^†

# participants affected / at risk

3/---

Gastrointestinal disorders

Epigastric soreness¹,^†

# participants affected / at risk

3/---

Gastrointestinal disorders

General-weakness¹,^†

# participants affected / at risk

3/---

Skin and subcutaneous tissue disorders

Hand foot syndrome¹,^†

# participants affected / at risk

3/---

Skin and subcutaneous tissue disorders

Hand-foot syndrome¹,^†

# participants affected / at risk

3/---

Nervous system disorders

Headache¹,^†

# participants affected / at risk

6/---

Gastrointestinal disorders

Indigestion¹,^†

# participants affected / at risk

3/---

Skin and subcutaneous tissue disorders

Itching¹,^†

# participants affected / at risk

16/---

Skin and subcutaneous tissue disorders

Mucositis¹,^†

# participants affected / at risk

3/---

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

12/---

Nervous system disorders

Neuropathy¹,^†

# participants affected / at risk

4/---

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

3/---

Respiratory, thoracic and mediastinal disorders

Rhinorrhea¹,^†

# participants affected / at risk

3/---

Skin and subcutaneous tissue disorders

Skin-rash¹,^†

# participants affected / at risk

14/---

Respiratory, thoracic and mediastinal disorders

Sorethroat¹,^†

# participants affected / at risk

3/---

Respiratory, thoracic and mediastinal disorders

Sputum¹,^†

# participants affected / at risk

10/---

Gastrointestinal disorders

Stomatitis¹,^†

# participants affected / at risk

9/---

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
2	Term from vocabulary,

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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description:

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Gerard Lynch
Organization:	Astrazeneca
E-mail:	[email protected]

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=410&filename=CSR-D7913L00056.pdf
Download
CSR-D7913L00056.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Korea Clinical Study Information

+82 2 2188 0848

Investigators

Principal Investigator

HyeJong Yoo

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=410&filename=CSR-D7913L00056.pdf

CSR-D7913L00056.pdf

Trial Results Summaries