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A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous XMT-1001 in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Cancer, Non-small Cell Lung Cancer

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Trial Information

A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous XMT-1001 in Patients With Advanced Solid Tumors


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical laboratory examinations: complete blood count (CBC) with differential, liver function tests, coagulation tests, serum chemistry, urinalysis

Outcome Time Frame:

At baseline, 8, 15, and 21 days post dosing

Safety Issue:

Yes

Principal Investigator

Edward Sausville, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

MER-001

NCT ID:

NCT00455052

Start Date:

March 2011

Completion Date:

June 2013

Related Keywords:

  • Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • XMT-1001
  • cancer
  • tumor
  • camptothecin
  • Fleximer
  • polymer
  • Phase 1
  • safety
  • pharmacokinetics
  • maximum tolerated dose
  • NSCLC
  • non-small cell lung cancer
  • SCLC
  • small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Rocky Mountain Cancer CentersThornton, Colorado  80260
University of Maryland, Greenebaum Cancer CenterBaltimore, Maryland  21201
Central Indiana Cancer CentersIndianapolis, Indiana  46227
New York Oncology HematologyAlbany, New York  12208
TGen Clinical Research Services at Scottsdale HealthcareScottsdale, Arizona  85258
Willamette Valley Cancer Institute and Research CenterSpringfield, Oregon  97477
Institute of Translational Oncology ResearchGreenville, South Carolina  29605
Texas Oncology - TylerTyler, Texas  75702
Evergreen Hematology & OncologySpokane, Washington  99218
Vancouver Cancer CenterVancouver, Washington  98684