NCT00522938

Clinical Trial of the Safety and Effectiveness of CHR-2797 With Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

A Phase I-II, Multicenter, Open-label Trial of Co-administered CHR-2797 and Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Chroma Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, multiple-dose, Phase I-II study of CHR-2797 co-administered with erlotinib in patients with histologically or pathologically confirmed Stage IIIB (with pleural effusion), Stage IV, or recurrent metastatic NSCLC. Throughout this protocol, "study medication" includes both CHR-2797 and erlotinib. This study will involve 2 distinct study phases. Study Phase A will assess safety and determine the MTD of the combination of CHR-2797 and erlotinib. In addition, PK profiles for the combination of CHR-2797 and erlotinib will be evaluated. In Study Phase B, the dose chosen based on the maximum tolerated dose established in Study Phase A will be administered in a single-arm treatment design in order to evaluate the efficacy of co-administration of CHR-2797 and erlotinib.

Detailed description

Study Phase A: Maximum tolerated dose will be determined during Cycle 1. Tumor assessments will be made after Cycle 2 (56 days), although it is not mandatory for Phase A patients to have measurable disease. Patients who have satisfactory outcomes after Cycle 2 may continue treatment for up to a year with erlotinib 150 mg/day, and the dose of CHR-2797 they received in Study Phase A. Study Phase B: Patients will be treated with the dose of CHR-2797 selected in Study Phase A and 150mg/day erlotinib. Patients will receive 2 cycles of treatment (56 days) before efficacy assessment. Patients who have complete response, partial response, or stable disease are eligible to continue the study for up to a year until disease progression or unacceptable toxicity. If a patient has complete response, partial response, or stable disease at the end of the 1-year study period and the Investigator believes that continuation treatment would be beneficial, the patient may continue to be treated at the dose of CHR-2797 under a separate protocol.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	CHR-2797 (tosedostat)	Once daily, oral ingestion of CHR-2797 capsules(PhaseI: 120mg, 160mg or 200mg depending on cohort or Phase II: recommended dose) capsules until progressive disease or withdrawal from the study
DRUG	erlotinib	Once daily, oral ingestion of erlotinib tablets 150mg tablets until progressive disease or withdrawal from the study. Per protocol, the Investigator may reduce the dose of erlotinib or cease treatment with erlotinib(per label) with Sponsor approval.

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-02-01
• Completion: 2008-04-01
• First posted: 2007-08-30
• Last updated: 2012-06-28

Locations

7 sites across 1 country: United States