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A Phase I Study of MK0646 in Patients With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors


Phase 1
20 Years
N/A
Not Enrolling
Both
Neoplasm

Thank you

Trial Information

A Phase I Study of MK0646 in Patients With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors


Inclusion Criteria:



- Histologically- Or Cytologically- Confirmed Metastatic Or Locally Advanced Solid
Tumors That Has Failed To Respond To Standard Therapy, Or For Which Adequate Standard
Therapy Dose Not Exist

- Tumors Associated With Igf-1r Expression In The Literature (E.G. Prostate,
Pancreatic, Colon, Lung And Breast)

- Ecog Performance Status 0 or 1

- Adequate Organ Function

Exclusion Criteria:

- Patient Who Has Had Chemotherapy, Radiotherapy, Or Biological Therapy Within 4 Weeks
(6 Weeks For Nitrosoureas Or Mitomycin C) Prior To Registration

- Patients Is Concurrently Using Growth Hormone (Gh), Or Growth Hormone Inhibitor

- Any Active CNS Metastases And/Or Carcinomatous Meningitis

- Any Primary Central Nervous System Tumor - Any Symptomatic Ascites Or Plural
Effusion

- A History Or Current Evidence Of Any Clinically Significant Disease That Might
Confound The Results Of The Study, Complicate The Interpretation Of The Study
Results, Interfere With The Patient'S Participation, Or Pose An Additional Risk To
The Patient

- Pregnant Or Breast-Feeding

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Any clinical or laboratory adverse experience.

Outcome Time Frame:

Duration of Treatment

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

2008_012

NCT ID:

NCT00694356

Start Date:

August 2008

Completion Date:

April 2009

Related Keywords:

  • Neoplasm
  • Neoplasms

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