Phase I Study of Indibulin in Combination With Erlotinib in Advanced Solid Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
Alaunos Therapeutics
Study ID
NCT00591383
Phase
PHASE1
Status
Unknown

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • indibulin — DRUG
    indibulin, dose escalation, 200 mg - 600 mg. Taken twice every day.
  • erlotinib — DRUG
    erlotinib taken at 150 mg every morning with food.

Study Details

Single arm, open label, Phase I, dose-escalation study of indibulin in combination with erlotinib in subjects with advanced histologically confirmed, solid tumors for which no standard therapy exists and for whom treatment with erlotinib is considered medically acceptable.

Key Dates

First listed
Jan 11, 2008
Start date
Jan 31, 2008
Status verified
Jul 2012
Primary completion
Jun 30, 2013
Completion
Jun 30, 2013

Study Design

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

Arms

  • Experimental: Single Arm
    Once Maximum Tolerated Dose (MTD) is determined an expanded cohort will be enrolled to evaluate efficacy.

Primary Outcome Measure

toxicities [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
-HoustonTexas--

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