Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Mersana Therapeutics Identifier:
First received: April 1, 2007
Last updated: April 3, 2013
Last verified: April 2013

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 (SCLC) and to test for preliminary anti-tumor activity in these tumor types. The MTD was initially defined as 113 mg CPT equivalents(eq)/m2 in the dose escalation part of the study. However, in the initial expansion phase (Protocol Amendment 11), 11 patients (10 NSCLC patients and 1 gastric cancer patients) were dosed at 113 mg CPT eq/m2 and less bone marrow toxicity was observed as compared to more heavily pre-treated patients in the dose escalation part of the study. Therefore, this amended expansion phase will investigate the safety and anti-tumor effects of a dose of 150 mg CPT eq/m2.

The study will also determine:

  • The safety and tolerability of XMT-1001 at 150 mg CPT eq/m2
  • The pharmacokinetics (PK) of XMT-1001 (how XMT-1001 behaves in the body) in patients Stage IV non-small cell lung carcinoma (NSCLC) and small cell lung cancer
  • Evidence of XMT-1001 anti-tumor activity at 150 mg CPT eq/m2

Condition Intervention Phase
Small Cell Lung Cancer
Non-small Cell Lung Cancer
Drug: XMT-1001
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous XMT-1001 in Patients With Advanced Solid Tumors

Resource links provided by NLM:

Further study details as provided by Mersana Therapeutics:

Primary Outcome Measures:
  • Clinical laboratory examinations: complete blood count (CBC) with differential, liver function tests, coagulation tests, serum chemistry, urinalysis [ Time Frame: At baseline, 8, 15, and 21 days post dosing ] [ Designated as safety issue: Yes ]
  • Electrocardiogram [ Time Frame: At baseline and after each 21-day cycle ] [ Designated as safety issue: Yes ]
  • Physical examinations [ Time Frame: At baseline, then 2 days (cycle 1 only) and 8 days post-dosing ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: At baseline, then 2 days (cycle 1 only), and 8 and 15 days post dosing ] [ Designated as safety issue: Yes ]
  • Blood sampling for pharmacokinetics [ Time Frame: Immediately prior to dosing, then 0.5, 1, 1.5, 2, 4, 6, 8, 24, and 48 hours post dosing ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Throughout post-dosing period and 30 days after study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
  • Time to tumor progression [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: XMT-1001
    XMT-1001 is administered as an IV infusion once every 21 days. This expansion of the Phase 1 study is to confirm the MTD.
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 dosing. Patients will be assessed for toxicities known to occur with other drugs of this class, such as bone marrow suppression, elevated liver function enzymes, hemorrhagic cystitis, and diarrhea. Tumor imaging will be performed every 2 cycles.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. At least 18 years old
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. At least 42 days since administration of mitomycin or nitrosoureas, and 28 days since any other chemotherapy, investigational agent, and/or radiation therapy.
  7. 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
  8. Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1.
  9. Have a life expectancy of at least 3 months.
  10. Have signed an informed consent form.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00455052

United States, Arizona
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Indiana
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
United States, Maryland
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New York
New York Oncology Hematology
New York, New York, United States, 12208
United States, Oregon
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States, 97477
United States, South Carolina
Institute of Translational Oncology Research
Greenville, South Carolina, United States, 29605
United States, Texas
Texas Oncology - Tyler
Tyler, Texas, United States, 75702
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Evergreen Hematology & Oncology
Spokane, Washington, United States, 99218
Vancouver Cancer Center
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
Mersana Therapeutics
Principal Investigator: Edward Sausville, MD University of Maryland Greenebaum Cancer Center
Principal Investigator: Glen J Weiss, MD TGen Clinical Research Services at Scottsdale Healthcare
Principal Investigator: Lawrence Garbo, MD New York Oncology Hematology
Principal Investigator: Allen Lee Cohn, MD Rocky Mountain Cancer Centers
Principal Investigator: Paul R. Conkling, MD Virginia Oncology Associates
Principal Investigator: William J Edenfield, MD Institute for Translational Oncology Research
Principal Investigator: Donald A. Richards, MD Texas Oncology - Tyler
Principal Investigator: John R. Caton, MD Willamette Valley Cancer Institute and Research Center
Principal Investigator: David A. Smith, MD Northwest Cancer Specialists - Vancouver Cancer Center
Principal Investigator: Hillary H. Wu, MD Central Indiana Cancer Centers
Principal Investigator: Fadi Braiteh, MD Comprehensive Cancer Centers of Nevada
Principal Investigator: Stephen Anthony, MD Evergreen Hematology & Oncology
  More Information

Responsible Party: Mersana Therapeutics Identifier: NCT00455052     History of Changes
Other Study ID Numbers: MER-001
Study First Received: April 1, 2007
Last Updated: April 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mersana Therapeutics:
Phase 1
maximum tolerated dose
non-small cell lung cancer
small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on November 20, 2014