Phase 1 Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer (NSCLC)

Conditions

• Non-small Cell Lung Cancer (NSCLC), Recurrent
• Non-small Cell Lung Cancer (NSCLC), Stage IV

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Erlotinib hydrochloride — DRUG
  Given PO
• Dovitinib lactate — DRUG
  Given PO

Study Details

This phase I trial studies the side effects and best dose of giving erlotinib and dovitinib together to treat patients with metastatic non-small cell lung cancer. Erlotinib blocks the epidermal growth factor receptor (EGFR) and has known activity in non-small cell lung cancer and dovitinib blocks the fibroblast growth factor receptor (FGFR) and other targets which may be important to treat lung cancer. The combination of both drugs may work better than either drug alone, but may also have increased side effects. This trial will look at the side effects of combining the drugs and look for how effective the combination may be.

Key Dates

Start date

Jul 31, 2012

Status verified

Jul 2016

Primary completion

Feb 28, 2013

Completion

Dec 31, 2014

Study Design

Enrollment

9 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (enzyme inhibitor therapy)
  Patients receive erlotinib hydrochloride PO QD. Starting on day 15, patients also receive dovitinib lactate PO QD on days 1-5 of each week. Treatment continues in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Measure toxicity to determine the MTD of the combination of erlotinib hydrochloride and dovitinib lactate [ Time Frame: 1 year ]

Locations (1)

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