Phase I/II, Evaluate the Safety and Efficacy of BLEX 404 With Docetaxel in Patients With Advanced/Metastatic Triple Negative Breast Cancer.

Sponsor
BioLite, Inc.
Study ID
NCT02802423
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • BLEX 404 Oral Liquid — DRUG
    BLEX 404 Oral Liquid is administered twice daily during the Docetaxel monotherapy period. The dose of Docetaxel is 75 mg/m2 IV, 21 days a cycle.

Study Details

The primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Docetaxel monotherapy in a 21-day schedule. The secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with Docetaxel monotherapy.

Key Dates

First listed
Jun 16, 2016
Start date
Jan 1, 2027
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Aug 28, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BLEX 404 Oral Liquid
    During Phase I study (dose escalation), a standard 3+3 design will be followed, and the dose range is 3 to 10 mg/kg BID. The recommended dose level (RDL) for the Phase II study is defined as the dose level with 0 to 1 DLT observed during cycle I of Docetaxel monotherapy among 6 patients in the Phase I study.

Primary Outcome Measure

Phase I: Dose-limiting toxicity (DLT) observation [ Time Frame: 3 weeks (1 cycle) ]

Central Contacts

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