test

A Phase I, Open-label, dose-escalation study of the safety and pharmacokinetics of MPDL3280A administered intravenously as a single agent to patients with locally advanced or metastatic solid tumors or hematologic malignancies

Conditions

Bladder | Breast - Female | Colon | Esophagus | Kidney | Larynx | Lip, Oral Cavity and Pharynx | Lung | Melanoma, skin | Multiple Myeloma | Non-Hodgkin's Lymphoma | Other Digestive Organ | Other Male Genital | Pancreas | Prostate | Rectum | Soft Tissue | Stomach | Thyroid

Trial Phase

Phase I

Trial Purpose and Description

Trial Purpose

Primary Objectives:

  • To evaluate the safety and tolerability of MPDL3280A administered by intravenous (IV) infusion every 3 weeks (q3w) to patients with locally advanced or metastatic solid tumors
  • To determine the maximum tolerated dose (MTD) and to evaluate the dose-limiting toxicities (DLTs) of MPDL3280A when administered as a single agent to patients by IV infusion q3w
  • To identify a recommended Phase II dose of MPDL3280A


Participation Guidelines

Age:
18 Years and older
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

  • Age >18 years
  • Histologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy
  • Measurable disease per RECIST v1.1 for patients with solid malignancies.
  • Adequate hematologic (not applicable for patients with AML, except for WBC and
    platelet counts) and end organ function.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • INR and aPTT < 1.5 x ULN- This applies only to patients who do not receive therapeutic anticoagulation
    patients receiving therapeutic anticoagulation should be on a stable dose.

Exclusion Criteria:

  • Any approved anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment.
  • AEs from prior anti-cancer therapy that have not resolved to Grade < 1 except for alopecia
  • Bisphosphonate therapy for symptomatic hypercalcemia
  • Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed.
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease.
  • Patients with acute promylocytic leukemias (FAB M3 or M3v), accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma.
  • Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases (> 2 lesions or requiring corticosteroids for symptomatic control).
  • Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
  • Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1
  • Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study.

Sponsor:
Genentech, Inc.
Dates:
05/03/2012
Last Updated:
Study HIC#:
1203009900