A Phase 2 Exploratory Study of Erlotinib and SNDX-275 in Participants With Non-small Cell Lung Carcinoma Who Are Progressing on Erlotinib

Part of paid clinical trials in San Diego, California.

Sponsor
Syndax Pharmaceuticals
Study ID
NCT00750698
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Entinostat — DRUG
    Entinostat (10 milligrams \[mg\] fixed dose orally \[PO\] every 2 weeks \[Q2W\]) on Days 1 and 15 of a 28-day cycle for up to 6 cycles
  • Erlotinib — DRUG
    Erlotinib (150 mg PO QD) for up to six (6) 28-day cycles

Study Details

To evaluate the tumor responses to SNDX-275 (entinostat) in combination with continued erlotinib in participants with non-small Cell Lung Carcinoma (NSCLC) who are progressing on erlotinib.

Key Dates

First listed
Sep 10, 2008
Start date
Aug 31, 2008
Status verified
Jul 2023
Primary completion
May 31, 2010
Completion
Jun 30, 2010

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib-responsive
    Participants self-administered entinostat in combination with continued erlotinib self-administration. "Erlotinib-responsive" participants are those who progressed following either a complete or partial response to erlotinib or a period of stable disease lasting at least 3 months.
  • Experimental: Erlotinib-nonresponsive
    Participants self-administered entinostat in combination with continued erlotinib self-administration. "Erlotinib-nonresponsive" participants are those who either progressed immediately during treatment with erlotinib (after at least 1 full cycle of erlotinib treatment) or had an objective response or period of stable disease lasting less than 3 months.

Primary Outcome Measure

Disease Control Rate (Complete Response, Partial Response, or Stable Disease for at Least 3 Months [ Time Frame: At least 3 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Sharp Clinical Oncology ResearchSan DiegoCalifornia92123-
University of MiamiMiamiFlorida33136-
Rush University Medical CenterChicagoIllinois60612-
Roswell Park Cancer InstituteBuffaloNew York--
Medical University of South CarolinaCharlestonSouth Carolina29425-

Find similar trials in San Diego, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Sharp Clinical Oncology Research· San Diego, CAUniversity of Miami· Miami, FLRush University Medical Center· Chicago, ILRoswell Park Cancer Institute· Buffalo, NYMedical University of South Carolina· Charleston, SC

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