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Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced or Metastatic Solid Tumours

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Trial Information

Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours


Inclusion Criteria:



1. Male or female 18 years of age or older.

2. Histologically confirmed diagnosis of solid tumour for which no effective therapy is
available or that is unresponsive to conventional therapy.

3. Meet laboratory parameter requirements at study entry.

Exclusion Criteria:

1. Chemotherapy, radiotherapy, biologic therapy, immunotherapy or any other
investigational drugs within 21 days of beginning study treatment with LOR-253 HCl.

2. A hematologic malignancy.

3. A history of brain or other central nervous system metastases.

4. Have a presence of a significant infection.

5. Clinically significant autoimmune disease.

6. Uncontrolled intercurrent illness.

7. With iron or copper overload syndromes.

8. Pregnancy or breast feeding.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.

Outcome Time Frame:

8 weeks

Safety Issue:

Yes

Principal Investigator

Andrea Cercek, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

253-SOL1-01

NCT ID:

NCT01281592

Start Date:

January 2011

Completion Date:

June 2013

Related Keywords:

  • Advanced or Metastatic Solid Tumours
  • Neoplasms

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021