An Umbrella, Modular Study Based on Epidermal Growth Factor Receptor (EGFR) Mutation Status
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT00903734
- Phase
- PHASE1
- Status
- Completed
Conditions
- Advanced Cancers
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Erlotinib Hydrochloride (Tarceva) — DRUGDose of 150 mg daily by mouth.
Study Details
The goal of this screening portion of this clinical research study is to learn if you are eligible to take part in a clinical research study using Tarceva (erlotinib hydrochloride) and either Erbitux (cetuximab), Velcade (bortezomib), or Sprycel (dasatinib). If the results of the screening portion of this clinical research study show that you are eligible to take part in one of the studies described above, the study drug that you will be assigned to take will depend on the results of biomarker analysis performed as a part of the screening tests described below. Biomarkers are chemical "markers" in the blood/tissue that may be related to how your body might react to the study drug.
Key Dates
- First listed
- May 18, 2009
- Start date
- Apr 30, 2009
- Status verified
- Jul 2015
- Primary completion
- Jul 31, 2015
Study Design
- Enrollment
- 16 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Erlotinib HydrochlorideThose eligible for umbrella of studies and have not received Erlotinib hydrochloride in past, will first receive Erlotinib hydrochloride alone.
Primary Outcome Measure
Maximum Tolerated Dose (MTD) and toxicity profiles via a brief initial "run-in"/dose escalation. [ Time Frame: Continous reassessment during dose level/cycles (28 days) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | - |
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