A Study of TAK-788 in Japanese Adults With Non-Small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    63
  • sponsor
    Takeda
Updated on 23 May 2021
Investigator
Takeda Study Registration Call Center
Primary Contact
Kyoto University Hospital (5.7 mi away) Contact
+24 other location
platelet count
measurable disease
lipase
growth factor
serum bilirubin level
metastasis
neutrophil count
epidermal growth factor receptor
HER2
EGFR
cancer chemotherapy
alopecia
erbb2
epidermal growth factor
adjuvant chemotherapy
stage iv non-small cell lung cancer
lung carcinoma

Summary

This study is in 2 parts. Different participants will take part in the 1st and 2nd parts of the study.

The main aim of the 1st part of the study is to check how much TAK-788 adults with non-small cell lung cancer (NSCLC) can receive without getting side effects from it.

The main aim of the 2nd part of the study is to learn if the condition of adults with non-small cell lung cancer improves after treatment with TAK-788. Another aim is to continue checking for side effects from TAK-788.

In the 1st part of the study, at the first visit, the study doctor will check who can take part. For those that can take part, participants will take a capsule of TAK-788 once a day for 28 days. This will count as 1 cycle. Different small groups of participants will receive lower to higher doses of TAK-788. The study doctors will check for side effects after each dose of TAK 788. In this way, researchers can work out the best dose of TAK-788 to give participants in the 2nd part of the study.

Participants will visit the clinic 30 days after their treatment has finished for a final check-up.

In the 2nd part of the study, at the first visit, the study doctor will check who can take part. Participants will receive the best dose of TAK-788 worked out from the 1st part of the study. Participants will receive TAK-788 in the same way as those from the 1st part of the study. The study doctors will learn if the condition of these participants improves after treatment with TAK-788. The study doctors will also check for side effects from TAK-788.

After treatment has finished, participants will visit the clinic every 12 weeks until the end of the study.

In both parts of the study, participants can receive TAK-788 for up to just over 1 year, or longer if their condition stays improved.

Description

The drug being tested in this study is called TAK-788. TAK-788 is being tested to treat Japanese participants with NSCLC. This study has two parts (Phase 1 part and Phase 2 part), Phase 1 part of this study will look at the safety, efficacy, tolerability and PK of TAK-788 orally administered once daily, and will determine a RP2D. Phase 2 study will look at the efficacy and safety of TAK-788 in treatment naive Japanese NSCLC patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation. All participants will be assigned to Phase 1 part or Phase 2 part and will be asked to take TAK-788 capsule as following dosage and regimen;

Phase 1 part; TAK-788, 40 mg as starting dose, once daily, and escalating up to 160 mg until a Maximum Tolerated Dose (MTD). An expansion phase may be followed at any dose to further confirm safety observations following identification of MTD/RP2D.

Phase 2 part; TAK-788, 160 mg, once daily

The study will enroll approximately 58-63 participants (Phase 1 part; 28-33 and Phase 2 part; 30).

This multi-center trial will be conducted in Japan. The overall time to participate in this study of Phase 1 part is approximately 3 years and Phase 2 part is approximately 4 years. Participants will make multiple visits to the clinic in the treatment period, and the post-treatment period including follow-up assessments after the last dose of the study drug.

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment TAK-788
Clinical Study IdentifierNCT03807778
SponsorTakeda
Last Modified on23 May 2021

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note