A Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)(0683-066)

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00424775
• Other study ID #: 0683-066
• Secondary ID: 2007_001
• Status: Terminated
• Phase: Phase 1
• First received: January 19, 2007
• Last updated: March 31, 2015
• Start date: January 2007
• Est. completion date: March 2007

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The clinical study will evaluate safety, tolerability and Pharmacokinetics of MK0683 in combination with carboplatin and paclitaxel in chemotherapy-naive NSCLC patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Neoplasms

Intervention

Drug:
• MK0683, vorinostat
vorinostat 300 mg or 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Dose Limited Toxicity at First Cycle	Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment.	25 Days (first cycle)	Yes
Secondary	Area Under the Curve (AUC(0-24 hr)) at Day 4	Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.	Day 4	No
Secondary	Area Under the Curve (AUC(0-24 hr)) at Day 5	Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.	Day 5	No
Secondary	Maximum Concentration (Cmax) at Day 4	Maximum Concentration (Cmax) = the maximum plasma concentration of the drug	Day 4	No
Secondary	Maximum Concentration (Cmax) at Day 5	Maximum Concentration (Cmax) = the maximum plasma concentration of the drug	Day 5	No