Clinical Utilization of Newly Approved Oncology Medications

Cancer Clinical Trial

Official title:

Clinical Utilization of Newly Approved Oncology Medications in Middle Eastern Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02783885
• Other study ID #: RC15/097/R
• Status: Recruiting
• Phase: N/A
• First received: May 12, 2016
• Last updated: May 23, 2016
• Start date: May 2016
• Est. completion date: September 2020

Study information

• Verified date: May 2016
• Source: National Guard Health Affairs
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Saudi Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The efficacy and safety of different medications vary from one individual to another and from one ethnic group to another. Therefore, strong interest in the study of pharmacogenomic and pharmacoepidemiology has evolved recently.

There are multiple examples of oncology drugs being more effective in certain ethnic population compared to other. For example, irinotecan combined with cisplatin was very effective drug in the management of small cell lung cancer in the Japanese patients while an identical study done in the US revealed no major benefit to this combination in American population

Description:

Another example is having more benefit drawn from tyrosine kinase inhibitors (Erlotinib or Gefitinib) in Asian patients.

Immunotherapy is a new class of cancer treatment that works to harness the innate powers of the immune system to fight cancer. Because of the immune system's unique properties, these therapies may hold greater potential than current treatment approaches to fight cancer more powerfully, to offer longer-term protection against the disease, to come with fewer side effects, and to benefit more patients with more cancer types

Immunotherapy includes treatments that work in different ways. Some boost the body's immune system in a very general way. Others help train the immune system to attack cancer cells specifically. Immunotherapy has become an important part of treating some types of cancer. Newer types of immune treatments are now being studied, and they'll impact how we treat cancer in the future.

Recently, multiple immunotherapy treatment been approved with a couple of EGFR resistant medications.

Many new oncology drugs are being used in Middle Eastern countries including Saudi Arabia for different indications without being studied in the Middle Eastern population. These medications' efficacy and safety profiles may differ from those patients studied for drug development and approval due to difference in population's characteristics.

The goal of this study is to observe, summarize and report the patterns of the use of these drugs and describe their efficacy and safety profile in the early phases of their use.

The investigators aim is to build on the existing experience and knowledge by utilization of classic methodology and approaches on a larger scale and more effective way to paint picture of the performance of a certain therapy in the real life world. The use of prospective design will help evaluate the efficacy and safety of therapies already used in practice, generate new hypothesis, and/or determine the outcome of certain diseases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients with cancer or hematological malignancies receiving new oncology medications (defined as a medication in the first five years of their introduction to the ME market

• Patient accepts to participate in study and signing consent form

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• immunotherapy

Locations

Country	Name	City	State
Saudi Arabia	King Abdul Aziz Medical City for National Guard	Riyadh
Saudi Arabia	King Abdul Aziz Medical City for National Guard Health Affairs	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
National Guard Health Affairs

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive measures of the pattern of use of the new medications in our population		3 years	No
Secondary	Measuring the efficacy in terms of response		3 years	No
Secondary	Measuring the efficacy in terms of progression-free survival (PFS)		3 years	No
Secondary	Measuring the efficacy in terms of overall survival (OS)		3 years	No