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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:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01356173
First received: May 17, 2011
Last updated: October 6, 2014
Last verified: October 2014

May 17, 2011
October 6, 2014
June 2011
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01356173 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma
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

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).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma, Solid Tumour
Drug: GDC-0349
Oral escalating dose
Experimental: A
Intervention: Drug: GDC-0349
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01356173
MKI4956g, MP00807
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Scott Holden, M.D. Genentech, Inc.
Genentech, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP