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A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors, Recurrent or Refractory Medulloblastoma, Locally Advanced or Metastatic Basal Cell Carcinoma

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Trial Information

A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, in Patients With Advanced Solid Tumors


Inclusion Criteria:



- Confirmed diagnosis of advanced solid tumor, recurrent or refractory medulloblastoma
or locally advanced or metastatic basal cell carcinoma)

- Protocol defined laboratory parameters

- Performance status ≤ 2

- Patients must have fully recovered from the prior effects of major surgery and from
any acute toxicities of prior chemotherapy/radiotherapy

Exclusion Criteria:

- History of central nervous system tumors of symptomatic brain metastases (excludes
medulloblastoma patients)

- Impairment of gastrointestinal function or unresolved nausea, vomiting or diarrhea

- Impairment of cardiac function or significant cardiac disease

- Pregnant or lactating women

- Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506

Outcome Time Frame:

21 day cycles

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLEQ506X2101

NCT ID:

NCT01106508

Start Date:

October 2010

Completion Date:

January 2014

Related Keywords:

  • Advanced Solid Tumors
  • Recurrent or Refractory Medulloblastoma
  • Locally Advanced or Metastatic Basal Cell Carcinoma
  • Advanced solid tumors
  • recurrent or refractory medulloblastoma
  • locally advanced or metastatic basal cell carcinoma
  • hedgehog pathway inhibitor
  • Carcinoma
  • Carcinoma, Basal Cell
  • Medulloblastoma
  • Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
University of California at Los Angeles UCLA LeConte LocationLos Angeles, California  90095