A Study of TAS-116 in Patients With Solid Tumors
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/20/2019 |
| Start Date: | May 1, 2017 |
| End Date: | March 2020 |
A Phase IA/IB Study Evaluating TAS-116 in Patients With Advanced Solid Tumors
A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first
initiated in Japan in April 2014 and has been ongoing since then. The study consists of a
dose escalation phase and a dose expansion phase. Three dosing regimens of TAS-116, once
daily (QD), every other day (QOD) and 5 days on/2 days off regimens in 21-day cycles, are
being evaluated. This phase I study is also planned to enroll patients with advanced solid
tumors in UK to confirm the MTD, safety, tolerability, and pharmacokinetics of TAS-116 in a
Western patient population in the dose expansion phase. In addition, patients with HER2+ MBC,
NSCLC harboring EGFR mutations or NSCLC harbouring ALK translocations will be further
evaluated for safety, tolerability, and efficacy in 3 separate cohorts at recommended dose of
TAS-116 on the 5 days on/2 days off regimen.
initiated in Japan in April 2014 and has been ongoing since then. The study consists of a
dose escalation phase and a dose expansion phase. Three dosing regimens of TAS-116, once
daily (QD), every other day (QOD) and 5 days on/2 days off regimens in 21-day cycles, are
being evaluated. This phase I study is also planned to enroll patients with advanced solid
tumors in UK to confirm the MTD, safety, tolerability, and pharmacokinetics of TAS-116 in a
Western patient population in the dose expansion phase. In addition, patients with HER2+ MBC,
NSCLC harboring EGFR mutations or NSCLC harbouring ALK translocations will be further
evaluated for safety, tolerability, and efficacy in 3 separate cohorts at recommended dose of
TAS-116 on the 5 days on/2 days off regimen.
Inclusion Criteria:
1. Male or females with an age ≥ 18 years (≥ 20 years in Japan)
2. Patients with histological- or cytological-confirmed, advanced unresectable breast,
gastric, or non-small cell lung cancer, who have progressed on (or not been able to
tolerate) standard therapy or for whom no standard anticancer therapy exists.
a. Part C: Only the following subtype of tumors with the molecular/genetic alterations
will be enrolled: HER2 positive MBC Advanced NSCLC, harboring EGFR mutations after
progression on osimertinib Advanced NSCLC, harboring ALK translocations after
treatment with alectinib or at least 2 ALK inhibitors
3. Has At least one measurable lesion as defined by RECIST criteria
4. Is able to take medications orally (e.g., no feeding tube).
5. Is able to agree to and sign informed consent and to comply with the protocol
6. Has adequate organ function
Exclusion Criteria:
1. Has a serious illness or medical condition(s)
2. Has received treatment with any prescribed treatments within specified time frames
prior to study drug administration
3. Significant ophthalmologic abnormality,
4. Impaired cardiac function or clinically significant cardiac disease
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Greenville, South Carolina 29605
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