LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00632489
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • LBH589 — DRUG
    LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.
  • Capecitabine — DRUG
    Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
  • Lapatinib — DRUG
    Lapatinib, 1000 mg PO daily will be added to this combination.

Study Details

This single center Phase I dose escalation trial will evaluate the safety, tolerability and efficacy of LBH589 when combined with capecitabine and lapatinib in three parts. Part 1 will determine the maximum tolerated doses (MTD) of LBH589 when combined with capecitabine. Parts 2 and 3 will be limited to locally recurrent or metastatic breast cancer patients, ICH 3+ overexpression or FISH amplification documented locally. Part 2 will evaluate the safety of the MTD of LBH589 determined in Part 1 when paired with lapatinib 1000 mg by mouth (PO) daily. Parts 2 and 3 will be limited to locally recurrent or metastatic breast cancer patients, ICH 3+ overexpression or FISH amplification documented locally. Part 3 will evaluate the tolerability and effectiveness of the triplet combination, LBH589, capecitabine and lapatinib in breast cancer patients.

Key Dates

Start date
May 31, 2008
Status verified
Jun 2015
Primary completion
Jan 31, 2009
Completion
Jul 31, 2011

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LBH589 with Capecitabine
    MTD, LBH589 with Capecitabine
  • Experimental: LBH589 and Lapatinib
    LBH589 and Lapatinib
  • Experimental: LBH589, Capecitabine and Lapatinib
    LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)

Primary Outcome Measure

To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil [ Time Frame: 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tennessee Oncology, PLLCNashvilleTennessee37023-

Find similar trials in Nashville, TN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Tennessee Oncology, PLLC· Nashville, TN

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