TBD

JRCT ID: jRCT2071210109

Registered date:13/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Taletrectinib is to be indicated for the treatment of adult Japanese patients with ROS1 or NTRK fusi
• Date of first enrollment: 22/12/2021
• Target sample size: 4
• Study type: Interventional
• Intervention(s): The starting dose in this study will be the final dose received in the previous study. Dose reduction by 1 level, or if needed by 2 levels, will be allowed depending on the type and severity of toxicity encountered. Dose reduction below a dose level of 200 mg is not allowed.

Outcome(s)

Primary Outcome

Safety endpoints:
Adverse events, laboratory tests, body weight, Phisical examination, vital signs, ECOG PS, ophthalmologic examination, 12-lead electrocardiography
Efficacy endpoints:
Tumor assessment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who, at the time of study enrollment, are on taletrectinib, maintain a response of SD or better, and have no tolerability concerns in the Phase I Clinical Study of DS-6051b and, in the opinion of the investigator, would benefit from ongoing treatment.
2. Able to take oral medications.
3. Has given voluntary consent in writing to participate in the study.
4. Males and/or females who meet any of the following criteria:
a) For males (irrespective of surgical sterilization [vasectomy]): agree to use effective contraception methods during the study intervention period and for at least 90 days after the last dose of study drug or agree with complete abstinence;
b) For females be post-menopausal for at least one year prior to screening or be documented surgically sterilized. Women of childbearing potential (WOCBP) must agree to use two concurrent effective methods of contraception or agree with complete abstinence from sexual intercourse since the informed consent until 90 days after the last dose of study drug. Usage of hormonotherapy for contraception should be recorded as well.

Exclude criteria

1.Any of the following findings at screening (as graded with CTCAE version 5.0)
a) Hematologic toxicity
> Grade 3 hematologic toxicity
b) Hepatotoxicity
>Grade 3 increase in AST and/or ALT (hereafter called AST/ALT )
c) Interstitial lung disease (ILD)/pneumonitis
d) Intolerable Grade 2 or > Grade 3 central nervous system event
e) > Grade 2 ocular toxicity
f) Other toxicity
> Grade 3 toxicity other than:
- Fatigue, nausea, vomiting, diarrhea, or anorexia that improves to Grade 2 or better within 3 days of appropriate supportive therapy
- Clinically insignificant transient laboratory test abnormalities
2. PAs of the day of enrollment, 21 or more days have passed since the last dose of taletrectinib in previous study
3. Requires anticancer therapy other than taletrectinib for the target disease
4. Has multiple treatment-requiring cancers
5. Female patients who are found to be pregnant or nursing for AEs not constituting
6. On a drug that is a potent CYP3A4/5 inhibitor or inducer or P-glycoprotein inhibitor or inducer or prior use within 14 days of enrollment
7. Otherwise found ineligible by the principal investigator or investigator

Related Information

• Primary Sponsor: Nakayama Tomoko