Phase 1
Completed N=61
Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC (MK0683-058)
Source: ClinicalTrials.gov NCT00423449 ↗Enrolled (actual)
61
Serious AEs
62.9%
Results posted
Aug 2011
Primary outcomePrimary: Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin — 0; 1; 0; 0 Participants
Summary
This is a clinical trial to determine the safety and tolerability of MK0683 in combination with gemcitabine and cisplatin and/or carboplatin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin |
0; 1; 0; 0; 1 | — |
| PRIMARY Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease |
400 | — |
| SECONDARY Number of Participants With Clinical Adverse Experiences (Safety and Tolerability) |
4; 6; 17; 27; 7 | — |
| SECONDARY Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability) |
2; 4; 7; 13; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Patient must have a histologically-confirmed metastatic or locally advanced non-small cell lung cancer that has not been previously treated with systemic chemotherapy or has received non-platinum and non-gemcitabine based neoadjuvant or adjuvant chemotherapy if the last dose was at least 6 months prior to study enrollment
Exclusion Criteria
- Patient who has had chemotherapy, radiotherapy, or biological therapy prior to entering the study, except for adjuvant or neoadjuvant chemotherapy, as allowed for treatment of a tumor
Data sourced from ClinicalTrials.gov (NCT00423449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.