GCC 0845:Vorinostat and Lapatinib in Advanced Solid Tumors and Advanced Breast Cancer to Evaluate Response and Biomarkers

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT01118975
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Vorinostat — DRUG
    300 mg 4 days on then 3 days off As defined in the protocol, the dose of vorinostat was increased to 400 mg 4 days on then 3 days off in the pilot phase because the adverse event threshold was not met. In the Phase II cohort, the dose of vorinistat was 400 mg 4 days on and 3 days off.
  • Lapatinib — DRUG
    1,250 mg once daily

Study Details

This research is being done to find out how safe and how well the combination of lapatinib and vorinostat works against advanced cancers.

Key Dates

Start date
Mar 31, 2010
Status verified
Oct 2019
Primary completion
Oct 31, 2012
Completion
Oct 31, 2012

Study Design

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

Arms

  • Experimental: Pilot Phase - Vornistat 200 to 400mg + Lapatinib
    lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
  • Experimental: Phase II - Vorinistat 400mg + Lapatinib
    lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days

Primary Outcome Measure

Dose Limiting Toxicities [ Time Frame: 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201-

Find similar trials in Baltimore, MD

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Maryland Greenebaum Cancer Center· Baltimore, MD

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