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

Recruiting

• Source

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  Public Title	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
  Acronym	Sorry, not currently available
  Source of Record URL	http://clinicaltrials.gov/show/NCT01375842

• Trial

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  Health Condition(s) or Problem	Solid Cancers
  Lay Summary	This Phase I, multicenter, first in human, open-label, dose escalation study will evaluate the safety, tolerability, and pharmacokinetics of MPDL3280A administered as single agent by intravenous (IV) infusion to patients with locally advanced or metastatic solid malignancies or hematologic malignancies. (from ClinicalTrials.gov)
  Who can enter the trial	Inclusion Criteria: - Histologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy - Representative tumor specimens in paraffin blocks/unstained slides, with an associated pathology report - Adequate hematologic and end organ function - Measurable disease per RECIST for patients with solid malignancies or per disease-specific criteria for patients with hematologic malignancies - ECOG: 0-1 Exclusion Criteria: - Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases - History or risk of autoimmune disease (i.e. SLE, RA, inflammatory bowel disease, Type I DM, autoimmune thyroid disease, vasculitis, etc.) - History of HIV, hepatitis B, or hepatitis C infection - Any signs or symptoms of infection - Malignancies other than disease under study within 5 years - Prior allogeneic stem cell transplant
  Who cannot enter the trial	Inclusion Criteria: - Histologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy - Representative tumor specimens in paraffin blocks/unstained slides, with an associated pathology report - Adequate hematologic and end organ function - Measurable disease per RECIST for patients with solid malignancies or per disease-specific criteria for patients with hematologic malignancies - ECOG: 0-1 Exclusion Criteria: - Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases - History or risk of autoimmune disease (i.e. SLE, RA, inflammatory bowel disease, Type I DM, autoimmune thyroid disease, vasculitis, etc.) - History of HIV, hepatitis B, or hepatitis C infection - Any signs or symptoms of infection - Malignancies other than disease under study within 5 years - Prior allogeneic stem cell transplant
  What will happen	Drug; MPDL3280A; Intravenous (IV) infusion repeating dose; A
  Primary aim	Incidence of dose limiting toxicities (DLTs); Nature of dose limiting toxicities (DLTs)
  Secondary Aim	Incidence of adverse events graded according to NCI CTCAE v4.0; Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first; No; Nature of adverse events graded according to NCI CTCAE v4.0; Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first; No; Severity of adverse events graded according to NCI CTCAE v4.0; Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first; No
  Participant Information Sheet	Sorry, not currently available
  Website	Sorry, not currently available
  Recruitment Status	Recruiting
  Nation	England
  Location	London

• Contact

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  Contact for Public Queries	Please reference Study ID Number: PCD4989g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com Clinical Trials Study Director Genentech
  Contact for Scientific Queries	Sorry, not currently available