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A Phase I Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)


Phase 1
20 Years
N/A
Not Enrolling
Both
Neoplasms

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Trial Information

A Phase I Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)


Inclusion Criteria:



- Chemotherapy-naive patients who are histologically or cytologically diagnosed NSCLC
with stage IIIB (not applicable of radical thoracic radiation) or stage IV

- Patients with normal organ function and bone marrow function

Exclusion Criteria:

- Given radical thoracic radiation for NSCLC or radiation for other than original
lesion within 3 weeks

- Any peripheral neuropathy above grade 2

- Any ascites, pleural effusion or pericardiac effusion which requires treatment

- Any uncontrolled concomitant illness

- 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:

Number of Participants With a Dose Limited Toxicity at First Cycle

Outcome Description:

Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment.

Outcome Time Frame:

25 Days (first cycle)

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

2007_001

NCT ID:

NCT00424775

Start Date:

January 2007

Completion Date:

March 2007

Related Keywords:

  • Neoplasms
  • Non-Small Cell Lung Cancer (NSCLC)
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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