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Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01356173
First Posted: May 19, 2011
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetic (PK) of GDC-0349 administered once daily (QD), orally (PO).

Condition Intervention Phase
Non-Hodgkin's Lymphoma, Solid Tumor Drug: GDC-0349 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence of dose limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0349 [ Time Frame: Up to 30 days ]

Secondary Outcome Measures:
  • Incidence of adverse events by NCI CTCAE v4.0 grade and associated dose of GDC-0349 [ Time Frame: Up to 2 years ]
  • Incidence of Grade 3 and 4 abnormalities in safety related laboratory parameters and associated dose of GDC-0349 [ Time Frame: Up to 30 days ]

Enrollment: 10
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: GDC-0349
Oral escalating dose

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented, locally advanced or metastatic solid malignancy or NHL without leukemic phase that has progressed or failed to respond to at least one prior regimen and/or are not candidates for regimens known to provide clinical benefit
  • Evaluable or measurable disease per RECIST v1.1 or IWG response criteria for patients with NHL and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels >= 5 ng/mL measured >= 2 weeks apart that meet the PSA, and Working Group criteria for progression prior to initiation of study treatment, and ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN >= 2 weeks apart prior to initiation of study treatment.
  • ECOG performance status of 0 or 1 at screening
  • Life expectancy of >= 12 weeks
  • Adequate hematologic and organ function within 14 days prior to initiation of study treatment
  • Documented willingness to use an effective means of contraception for both men and women while participating in the study and for 90 days after the last dose of GDC-0349
  • Willingness to provide archival tumor tissue

Exclusion Criteria:

  • Leptomeningeal disease as the only manifestation of the current malignancy
  • History of Type 1 or 2 diabetes requiring daily medication
  • Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for >= 3 months prior to initiation of study treatment
  • Active congestive heart failure or ventricular arrhythmia requiring medication
  • Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to initiation of study treatment
  • Active infection requiring intravenous (IV) antibiotics
  • Patients requiring any daily supplemental oxygen
  • Uncontrolled hypomagnesemia or hypokalemia
  • Any condition requiring anti-coagulants such as warfarin, heparin, or anti-thrombotics. Prophylactic anti-coagulation and/or local application of thrombolytic agents for catheter patency may be allowed for patients with normal INR and with prior approval from the Medical Monitor
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Known human immunodeficiency virus (HIV) infection
  • Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications
  • Significant traumatic injury within 3 weeks prior to initiation of GDC-0349
  • Major surgical procedure within 4 weeks prior to initiation of GDC-0349
  • Treatment with chemotherapy, hormonal therapy (except GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, or radiation therapy (except palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment. Kinase inhibitors, approved by national regulatory authorities, may be used up to 2 weeks prior to initiation of GDC-0349, provided that any drug-related toxicity has completely resolved and prior approval is obtained from the Medical Monitor.
  • Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0349
  • Treatment with an investigational agent within 4 weeks prior to initiation of GDC-0349
  • Unresolved toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
  • Pregnancy or lactation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356173


Locations
United States, Arizona
Scottsdale, Arizona, United States, 85258
Canada, Ontario
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Scott Holden, M.D. Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01356173     History of Changes
Other Study ID Numbers: MKI4956g
MP00807 ( Other Identifier: Hoffmann-La Roche )
First Submitted: May 17, 2011
First Posted: May 19, 2011
Last Update Posted: November 2, 2016
Last Verified: November 2016

Keywords provided by Genentech, Inc.:
solid cancers

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases