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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Chroma Therapeutics
Study ID
NCT00522938
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CHR-2797 (tosedostat) — DRUG
    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
  • erlotinib — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 30, 2007
Start date
Dec 31, 2007
Status verified
Feb 2012
Primary completion
Feb 29, 2008
Completion
Apr 30, 2008

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Primary Outcome Measure

Study Phase A- To determine the safety, tolerability, and maximum tolerated dose (MTD) of CHR-2797 when co-administered with erlotinib [ Time Frame: end of study ]

Locations (7)

FacilityCityStateZIPSite coordinators
Tower Cancer Research FoundationBeverly HillsCalifornia90210-
Medical Oncology Care AssociatesOrangeCalifornia92868-
Oncology Associates of West KentuckyPaducahKentucky42003-
Richmond University Medical CenterStaten IslandNew York10310-
Montefiore Medical CenterThe BronxNew York10467-
Clinworks Research CenterCharlotteNorth Carolina28207-
Carolina BioOncology InstituteHuntersvilleNorth Carolina28070-

Find similar trials in Beverly Hills, CA

By research site
Tower Cancer Research Foundation· Beverly Hills, CAMedical Oncology Care Associates· Orange, CAOncology Associates of West Kentucky· Paducah, KYRichmond University Medical Center· Staten Island, NYMontefiore Medical Center· The Bronx, NYClinworks Research Center· Charlotte, NC

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