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Phase Ib Trial of MPDL3280A with Bevacizumab or with Bevacizumab + FOLFOX in Patients with Solid Tumors

Conditions

Colon | Lung | Rectum

Trial Phase

Phase IB

Trial Purpose and Description

Trial Purpose

The purpose of this study is to find the best dose, and what affects, good and/or bad, and experimental drug (MPDL3280A) has when used in combination with bevacizumab and with bevacizumab plus FOLFOX chemotherapy to treat subjects with locally advanced or metastatic solid tumors.


Participation Guidelines

Age:
18 Years and older
Gender:
Both

Eligibility Criteria

Patients must meet the following criteria for study entry:

  • Signed Informed Consent Form
  • 18 years old
  • Availability at the site of tumor specimens in paraffin blocks (preferred) or 15 unstained slides, with an associated pathology report, prior to study entry. If archival tissue is either insufficient or unavailable, the patient may still be eligible, upon discussion with the Medical Monitor, if the patient can provide 5 unstained, serial slides or is willing to consent to and undergo a pretreatment core or excisional biopsy of the tumor (cytologic or fine-needle aspiration samples are not acceptable) or is enrolled in a dose-escalation cohort
  • Adequate hematologic and end organ function, defined by the following laboratory results obtained within 2 weeks prior to initiation of study treatmen
  • Measurable disease per RECIST v 1.1
  • For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use an effective form of contraception (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for 6 months after discontinuation from the study
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Sponsor:
Genentech, Inc.
Dates:
10/07/2013
Last Updated:
Study HIC#:
1306012219