A Study of Intravenous XMT-1107 in Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mersana Therapeutics
ClinicalTrials.gov Identifier:
NCT01011972
First received: November 10, 2009
Last updated: May 15, 2013
Last verified: May 2013

November 10, 2009
May 15, 2013
March 2010
September 2013   (final data collection date for primary outcome measure)
The primary objective of this study is to determine the maximum tolerated dose of XMT-1107 when given via IV once every three weeks. [ Time Frame: Adverse events are assessed during each treatment cycle. ] [ Designated as safety issue: Yes ]
The primary objective of this study is to determine the maximum tolerated dose of XMT-1107 given IV once every three weeks. [ Time Frame: Adverse events are assessed during each treatment cycle. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01011972 on ClinicalTrials.gov Archive Site
  • Assess the pharmacokinetics (PK) of XMT-1107 and its release product [ Time Frame: Samples for PK are collected during Cycle 1 and prior to each subsequent treatment cycle ] [ Designated as safety issue: No ]
  • Determine the recommended Phase 2 dose of XMT-1107 [ Time Frame: Throughout Cycle 1 ] [ Designated as safety issue: Yes ]
  • Assess the safety of XMT-1107. [ Time Frame: Throughout Cycle 1 ] [ Designated as safety issue: Yes ]
  • Observe for evidence of anti-tumor activity by XMT-1107. [ Time Frame: Course of study ] [ Designated as safety issue: No ]
  • Monitor the effect of XMT-1107 on MetAP2 inhibition in leukocytes from patients [ Time Frame: Cycle 1 and Cycle 2 ] [ Designated as safety issue: No ]
Assess the pharmacokinetics (PK) of XMT-1107 and its release product [ Time Frame: Samples for PK are collected during Cycle 1 and prior to each subsequent treatment cycle ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Intravenous XMT-1107 in Patients With Advanced Solid Tumors
A Phase 1 Study of the Safety and Pharmacokinetics of XMT-1107 Administered as an Intravenous Infusion Once Every Three Weeks to Patients With Advanced Solid Tumors

XMT-1107 has been shown in nonclinical studies to slow the growth of tumors. These effects may result from blocking the growth of new blood vessels that help the tumors survive.

This is an open-label, ascending-dose study of XMT-1107 administered intravenously over 90 minutes every 21 days (1 cycle). Blood sampling for PK analyses will be performed immediately prior to dosing and after dosing. Adverse events will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria (CTC) version 4.0 (CTCAE v4.0)

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
Drug: XMT-1107
XMT-1107 is administered IV once every 21 days.
Experimental: XMT-1107, intravenous infusion
Intervention: Drug: XMT-1107
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient must have a histological diagnosis of advanced solid tumor and must be refractory to standard therapy or have no effective therapy.
  • Measurable or evaluable disease.
  • At least 42 days since administration of mitomycin or nitrosoureas and 28 days since any other chemotherapy, investigational agent, and/or radiation therapy.
  • Age ≥ 18 years old.
  • Have the following laboratory values:

    • Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
    • Platelet count ≥ 100,000 cells/mm3
    • Hemoglobin ≥ 9 g/dL
    • Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min (Calculated by Cockroft and Gault method. Creatinine clearance (mL/min) = (140-age) x weight (kg)/72 x (serum creatinine in mg/dL) = ml**/min (**for females, multiply results by 0.85))
    • Total bilirubin ≤ 1.5 mg/dL or ≤ upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the institutional upper limit of normal (ULN) or ≤ 5 times ULN of liver metastases are present
    • Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5 times the ULN
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
  • Life expectancy of at least 3 months.
  • Signed informed written consent.

Exclusion Criteria:

  • Known brain metastases (either currently or previously).
  • Peripheral neuropathy ≥ Grade 2.
  • Ataxia ≥ Grade 1.
  • Cognitive disturbance ≥ Grade 1.
  • History of seizures.
  • Patients known to be human immunodeficiency virus (HIV) positive.
  • Active infections requiring IV antibiotics or serious intercurrent illness, including hepatitis B or C.
  • Unstable angina, recent myocardial infarction (within the previous 6 months), or use of ongoing maintenance therapy for life-threatening arrhythmia.
  • Known hypersensitivity to this class of drugs.
  • Pregnant or nursing women, women who are of childbearing potential and are not using an effective method of either barrier or hormonal contraceptives. Men who are not using an effective method of barrier contraceptive, or who would not be willing to continue to use these effective methods for the duration of the study.
  • Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury ≤ 4 weeks prior to beginning treatment.
  • Patients with proteinuria at screening as demonstrated by either:

    1. urine protein creatinine (UPC) ratio ≥ 1.0 at screening OR
    2. urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection, and must demonstrate ≤ 1 g of protein/24 hours to be eligible)
  • Patients with a serious non-healing wound, active ulcer, or untreated bone fracture.
  • Patients with history of hematemesis or hemoptysis (defined as having bright red blood of ½ teaspoon or more per episode) ≤ 1 month prior to study enrollment.
  • Inadequately controlled hypertension (defined as systolic blood pressure >140 mm Hg and/or diastolic blood pressure > 90 mm Hg while on antihypertensive medications). Initiation of antihypertensive agents is permitted provided adequate control is documented at least 1 week prior to beginning study treatment.
  • Significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) ≤ 6 months prior to Day 1 of treatment.
  • History of stroke or transient ischemic attack ≤ 6 months prior to beginning treatment.
  • Any prior history of hypertensive crisis or hypertensive encephalopathy.
  • History of abdominal fistula or gastrointestinal perforation ≤ 6 months prior to Day 1 of beginning treatment.
  • QTc interval > 470 milliseconds as calculated by Bazett's formula.
  • Any issue that, in the opinion of the Investigator, would render the patient unsuitable for study participation.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01011972
MER-1107-001
No
Mersana Therapeutics
Mersana Therapeutics
Not Provided
Not Provided
Mersana Therapeutics
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP