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A Study Evaluating GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma
This study is not yet open for participant recruitment.
Verified by Genentech, February 2009
First Received: February 27, 2009   No Changes Posted
Sponsored by: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00854126
  Purpose

This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Solid Cancers
Drug: GDC-0980
Phase I

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment
Official Title: An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0980 Administered Once Weekly in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Occurrence of adverse events [ Time Frame: Length of study ]
  • Occurrence of dose-limiting toxicities [ Time Frame: Length of study ]
  • Occurrence of Grade 3 and 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0980 [ Time Frame: Length of study ]
  • PK parameters after doses of GDC-0980 [ Time Frame: Length of study ]

Secondary Outcome Measures:
  • Best overall response, duration of objective response, and progression-free survival for patients with measurable disease according to RECIST [ Time Frame: Length of study ]
  • PET response for patients with detectable FDG tumor uptake at baseline [ Time Frame: Length of study ]

Estimated Enrollment: 63
Study Start Date: April 2009
Arms Assigned Interventions
1: Experimental Drug: GDC-0980
Escalating repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented, incurable, locally advanced or metastatic solid malignancies, or NHL without leukemic phase, that has progressed despite standard of care therapy or for which there is no standard therapy of proven clinical benefit
  • A biopsy-accessible lesion from which tissue can be obtained safely
  • Evaluable or measurable disease per RECIST and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels that meet the PSA Working Group criteria for progression prior to initiation of study treatment; 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.
  • Life expectancy ≥ 12 weeks
  • Adequate hematologic and organ function within 28 days before initiation of GDC-0980
  • Documented willingness to use an effective means of contraception for both men and women while participating in the study

Exclusion Criteria:

  • Leptomeningeal disease as the only manifestation of the current malignancy
  • History of Type 1 or 2 diabetes mellitus requiring regular medication
  • Grade ≥ 2 hypercholesterolemia or hypertriglyceridemia
  • Any condition requiring anti-coagulants such as warfarin, heparin, or anti-thrombotics
  • Malabsorption syndrome or other condition that would interfere with enteral absorption
  • Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for ≥ 3 months
  • Active congestive heart failure or ventricular arrhythmia requiring medication
  • Active infection requiring IV antibiotics
  • Requirement for any daily supplemental oxygen
  • Uncontrolled hypomagnesemia
  • Hypercalcemia requiring continued use of bisphosphonate therapy
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Known HIV infection
  • Significant traumatic injury within 4 weeks of Day 1
  • Major surgical procedure within 4 weeks prior to initiation of GDC-0980
  • Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives, or GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 3 weeks prior to initiation of GDC-0980
  • Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0980
  • Need for chronic corticosteroid therapy of ≥ 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant
  • Treatment with an investigational agent within 4 weeks prior to initiation of GDC-0980
  • Unresolved toxicity from prior therapy except for alopecia and Grade 1 peripheral neuropathy
  • Pregnancy or lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854126

Sponsors and Collaborators
Genentech
Investigators
Study Director: Mika Derynck, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers: PIM4605g
Study First Received: February 27, 2009
Last Updated: February 27, 2009
ClinicalTrials.gov Identifier: NCT00854126     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
NHL
Solid Tumors
Carcinogenic Tumors

Study placed in the following topic categories:
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

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

ClinicalTrials.gov processed this record on May 06, 2009