Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer

Part of paid clinical trials in Long Beach, California.

Sponsor
Kyowa Kirin Co., Ltd.
Study ID
NCT01199367
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KW-2450 in combination with lapatinib and letrozole — DRUG
    Three subjects will be assigned to each of 4 sequential cohorts. Dose escalation may proceed once at least 3 subjects have completed 30 days of study treatment. Subjects who withdraw prior to completing Day 30 for reasons other than DLT will be replaced. If a DLT is observed, additional subjects may be enrolled so that up to 6 subjects are enrolled at that dose level.

Study Details

This study will determine the highest dose of KW-2450 in combination with lapatinib and letrozole that can be administered safely to subjects with advanced or metastatic breast cancer and to evaluate its effectiveness. This study was terminated in Phase 1 and never proceeded to the Phase 2 portion of the study.

Key Dates

Start date
Dec 31, 2010
Status verified
Apr 2024
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escallation

Primary Outcome Measure

To establish the safety, tolerability, and recommended Phase 2 dose of KW-2450 administered in combination with lapatinib and letrozole in subjects with previously treated or untreated advanced breast cancer. [ Time Frame: 30 Days ]

Locations (5)

FacilityCityStateZIPSite coordinators
Breastlink Research GroupLong BeachCalifornia90250-
Associates in Hematology-OncologyLos AngelesCalifornia90057-
Sylvester Comprehensive Cancer CenterDeerfield BeachFlorida33136-
Clinical Oncology AssociatesFarmington HillsMichigan48336-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Long Beach, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Breastlink Research Group· Long Beach, CAAssociates in Hematology-Oncology· Los Angeles, CASylvester Comprehensive Cancer Center· Deerfield Beach, FLClinical Oncology Associates· Farmington Hills, MIMD Anderson Cancer Center· Houston, TX

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