Osimertinib Study in Indian Patients
Study Details
Study Description
Brief Summary
This is a prospective, single-arm, multicenter, phase-IV study investigating the safety of osimertinib in Indian adult patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
This is a prospective, single-arm, multicenter, phase-IV trial investigating the safety of osimertinib in Indian adult patients with locally advanced or metastatic EGFR-T790M mutation-positive NSCLC.
Prior to data collection, all patients must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements and sponsor policy.
Patients with metastatic EGFR T790M mutation-positive NSCLC, who are eligible to osimertinib treatment as per locally approved prescribing information and ratified by an independent clinical judgment of treating physician will be evaluated for the inclusion into the current phase-IV study based on eligibility criteria. EGFR T790M positivity on plasma or tissue biopsy on PCR-based platform will be considered appropriate test. EGFR T790M must be performed after progressive disease on last line of therapy (on or after EGFR TKI therapy). In order to enroll approximately 60 patients, it is expected that approximately 70 patients will be screened.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Single arm |
Drug: Osimertinib
Osimertinib is an oral, potent, selective, irreversible inhibitor of both epidermal growth factor receptor - Tyrosine kinase inhibitors (EGFR-TKI) sensitizing and resistance mutations in nonsmall cell lung cancer (NSCLC) with a significant selectivity margin over wild-type EGFR.
|
Outcome Measures
Primary Outcome Measures
- Safety of Osimertinib [5 months]
Number of Patients with treatment emergent Adverse Events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient of either gender and ≥18 years of age
-
Patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an appropriate test, who have progressed on or after EGFR TKI therapy by an independent clinical judgment of treating physician based on locally approved prescribing information
-
Each patient must sign an informed consent form (ICF)
Exclusion Criteria:
-
Patient with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug.
-
Pregnant and/or lactating women
-
Patients participating in any current or future interventional trial will not be enrolled in the current study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Hyderabad | India | 500034 | |
| 2 | Research Site | Hyderabad | India | 500096 | |
| 3 | Research Site | Kolkata | India | 700160 | |
| 4 | Research Site | Mumbai | India | 400012 | |
| 5 | Research Site | Mumbai | India | 400053 | |
| 6 | Research Site | New Dehli | India | 110029 | |
| 7 | Research Site | New Delhi | India | 110085 |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- D5161C00005
Study Results
Participant Flow
| Recruitment Details | This was a prospective, open label, single arm, multicentre, India-specific Phase 4 study to investigate the safety of osimertinib 80 mg tablet in Indian adults with metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non small cell lung cancer (NSCLC). 60 Indian subjects were enrolled into the study. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Single Arm |
|---|---|
| Arm/Group Description | single arm, open label study and Osimertinib 80 mg tablet was given orally once daily. |
| Period Title: Overall Study | |
| STARTED | 60 |
| COMPLETED | 51 |
| NOT COMPLETED | 9 |
Baseline Characteristics
| Arm/Group Title | Single Arm |
|---|---|
| Arm/Group Description | single arm, open label study and Osimertinib 80 mg tablet was given orally once daily. |
| Overall Participants | 60 |
| Age (Years) [Median (Full Range) ] | |
| Median (Full Range) [Years] |
58
|
| Sex: Female, Male (Count of Participants) | |
| Female |
31
51.7%
|
| Male |
29
48.3%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Asian (Only Indian) |
60
100%
|
Outcome Measures
| Title | Safety of Osimertinib |
|---|---|
| Description | Number of Patients with treatment emergent Adverse Events |
| Time Frame | 5 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm |
|---|---|
| Arm/Group Description | single arm, open label study and Osimertinib 80 mg tablet was given orally once daily. |
| Measure Participants | 60 |
| Count of Participants [Participants] |
60
100%
|
Adverse Events
| Time Frame | 6 months | |
|---|---|---|
| Adverse Event Reporting Description | An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. | |
| Arm/Group Title | Single Arm | |
| Arm/Group Description | single arm, open label study and Osimertinib 80 mg tablet was given orally once daily. | |
All Cause Mortality |
||
| Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/60 (5%) | |
Serious Adverse Events |
||
| Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 7/60 (11.7%) | |
| Blood and lymphatic system disorders | ||
| Thrombocytopenia | 1/60 (1.7%) | 1 |
| Cardiac disorders | ||
| Cardio-respiratory arrest | 1/60 (1.7%) | 1 |
| Eye disorders | ||
| Cataract | 1/60 (1.7%) | 1 |
| Gastrointestinal disorders | ||
| Mouth Ulceration | 1/60 (1.7%) | 1 |
| Diarrhoea | 1/60 (1.7%) | 1 |
| General disorders | ||
| Mucosal inflammation | 1/60 (1.7%) | 1 |
| Disease progression | 1/60 (1.7%) | 1 |
| Infections and infestations | ||
| Dengue fever | 1/60 (1.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnoea | 2/60 (3.3%) | 2 |
| Vascular disorders | ||
| Deep Vein Thrombosis | 1/60 (1.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 51/60 (85%) | |
| Blood and lymphatic system disorders | ||
| Thrombocytopenia | 4/60 (6.7%) | 4 |
| Gastrointestinal disorders | ||
| Diarrhoea | 5/60 (8.3%) | 6 |
| Constipation | 4/60 (6.7%) | 4 |
| General disorders | ||
| Fatigue | 6/60 (10%) | 7 |
| Decreased appetite | 5/60 (8.3%) | 5 |
| Mucosal inflammation | 4/60 (6.7%) | 4 |
| Infections and infestations | ||
| Paronychia | 4/60 (6.7%) | 5 |
| Investigations | ||
| Blood creatine phosphokinase increased | 6/60 (10%) | 7 |
| Musculoskeletal and connective tissue disorders | ||
| Pain in extremity | 4/60 (6.7%) | 4 |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 5/60 (8.3%) | 5 |
| Skin and subcutaneous tissue disorders | ||
| Rash | 4/60 (6.7%) | 7 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The institution and/or investigator/Physician or Sponsor will provide a copy of any proposed publication or presentation for review and comment at least sixty (60) days prior to submission for publication.
Results Point of Contact
| Name/Title | Global Clinical Lead |
|---|---|
| Organization | AstraZeneca |
| Phone | 1-877-240-9479 ext 8772409479 |
| information.center@astrazeneca.com |
- D5161C00005