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:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01356173
First received: May 17, 2011
Last updated: July 7, 2014
Last verified: July 2014
  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 da ily (QD), orally (PO).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Incidence of Grade 3 and 4 abnormalities in safety related laboratory parameters and associated dose of GDC-0349 [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356173

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

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01356173     History of Changes
Other Study ID Numbers: MKI4956g, MP00807
Study First Received: May 17, 2011
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
solid cancers

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

ClinicalTrials.gov processed this record on July 24, 2014