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Phase I and Pharmacokinetics Study of Lapatinib in Combination With Sorafenib in Patients With Advanced Refractory Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

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Trial Information

Phase I and Pharmacokinetics Study of Lapatinib in Combination With Sorafenib in Patients With Advanced Refractory Solid Tumors


Inclusion Criteria:



- Patients with locally advanced, recurrent or metastatic histologically confirmed
malignancy refractory to available standard treatment

Exclusion Criteria:

- Prior treatment with Lapatinib, Sorafenib or any agents targeting EGFR (other than
trastuzumab), Raf, VEGF, or VEGFR

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the dose limiting toxicities (DLTs)and the maximum tolerated dose (MTD) of the combination of Lapatinib and Sorafenib.

Outcome Time Frame:

0ne year

Safety Issue:

No

Principal Investigator

Armando Santoro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Clinico Humanitas

Authority:

Italy: Ministry of Health

Study ID:

ONC-2008-005

NCT ID:

NCT00984425

Start Date:

September 2009

Completion Date:

September 2010

Related Keywords:

  • Solid Tumors
  • Locally advanced, recurrent or metastatic histologically confirmed malignancy refractory to available standard treatment
  • Neoplasms

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