Status:
COMPLETED
A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors
Lead Sponsor:
Mersana Therapeutics
Conditions:
Small Cell Lung Cancer
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This amended expansion phase of the protocol is to further the experience at a dose level of 150 mg CPT eq/m2 in patients with Stage IV non-small cell lung cancer (NSCLC) and small cell lung cancer (S...
Detailed Description
This is an open-label study of XMT-1001 administered intravenously over 4 hours every 21 days (1 Cycle). Blood sampling for PK analyses will be performed immediately prior to dosing, and 9 times after...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- At least 18 years old
- Have histological or cytological documentation of one of the following:
- A. NSCLC with Stage IV disease according to the American Joint Cancer Commission TNM Staging (7th Edition)
- Have received at least one prior chemotherapy regimen but no more than two chemotherapy regimens for their advanced disease (not containing irinotecan or topotecan).
- Adjuvant chemotherapy will be considered as a prior chemotherapy regimen only if it is completed less than 6 months prior to enrollment.
- Treatment with erlotinib or crizotinib as single agents will not be considered as a chemotherapy regimen for purposes of this trial OR B. SCLC with Stage IV (extensive) or recurrent disease after definitive treatment for limited stage disease according to the American Joint Cancer Commission TNM Staging (7th Edition)1
- Have received at least one prior chemotherapy regimen but no more than two chemotherapy regimens for their advanced disease (not containing irinotecan or topotecan).
- Adjuvant chemotherapy will be considered as a prior chemotherapy regimen only if it is completed less than 6 months prior to enrollment.
- Patients must be refractory or resistant to standard therapy or for whom standard therapy is not anticipated to be curative and who have progressed through prior regimens.
- Patients must have measurable disease with at least one lesion that can be accurately measured by Response Evaluation Criteria in Solid Tumors (RECIST). The lesion size must be ≥20 mm by conventional radiological techniques or ≥10 mm by spiral CT scan. Disease in an irradiated field as the only site of measurable disease is acceptable if there has been a clear progression of the lesion. PET scans are not suitable for providing these measurements. For patients who are sensitive to contrast, MRI may be used.
- Patients with CNS metastases are acceptable provided that the disease has been treated (e.g. surgery, whole brain radiotherapy, stereotactic radiotherapy etc.) and the patient is stable for at least two weeks and does not require steroids (at least one week off steroids). Anti-seizure medication is allowed at the discretion of the treating physician.
- At least 42 days since administration of mitomycin or nitrosoureas, and 28 days since any other chemotherapy, investigational agent, and/or radiation therapy.
- Have the following laboratory values:
- Absolute neutrophil count (ANC) ≥1500 cells/mm3
- Platelet count \>100,000 cells/mm3
- Hemoglobin ≥9.0 g/dL
- Adequate renal function (serum creatinine ≤2 mg/dL) and creatinine clearance ≥45 mL/min (Calculated by Cockroft and Gault method)
- Adequate hepatic function (bilirubin ≤1.5 mg/dL)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the institutional upper limit of normal (ULN, or
- 5 times the ULN if liver metastases are present)
- Albumin of \>3.0 g/dL
- PT and PTT ≤1.5 times the ULN
- Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1.
- Have a life expectancy of at least 3 months.
- Have signed an informed consent form.
Exclusion
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00455052
Start Date
March 1 2011
End Date
December 1 2011
Last Update
January 31 2018
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
2
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
3
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
4
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201