A Study Evaluating GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00854152
First received: February 27, 2009
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

This is an open-label, multicenter, Phase I study to evaluate the safety, tolera bility, and pharmacokinetics of escalating oral doses of GDC-0980 administered t

o patients with incurable, locally advanced or metastatic solid malignancy or NH L 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 1

Study Type: Interventional
Study Design: Allocation: Non-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, Tolerability, and Maximally Tolerated Dose of GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors and Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Occurrence of adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Occurrence of dose-limiting toxicities [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • PK parameters after doses of GDC-0980 [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Occurrence of Grade 3 and 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0980 [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best overall response, duration of objective response, and progression-free survival for patients with measurable disease [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: March 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
  • ECOG performance status of 0 or 1 at screening
  • 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 14 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
  • Ejection fraction that is <50% or below the LLN (whichever is higher), as determined by echocardiogram or MUGA scan
  • DLCO < 50% of predicted value corrected for hemoglobin and alveolar volume prior to initiation of GDC-0980
  • 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
  • Uncontrolled ascites requiring frequent paracentesis
  • Known HIV infection
  • Any other diseases, active or controlled 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
  • Significant traumatic injury within 4 weeks of Day 1
  • Major surgical procedure within 4 weeks prior to initiation of GDC-0980
  • For all patients participating in Stage 2: Prior treatment with any PI3K inhibitor, mTOR inhibitor or dual PI3K/mTOR inhibitor. For HNSCC patients, this restriction applies only to any PI3K inhibitor, mTOR inhibitor, or dual PI3K/mTOR inhibitor used in the palliative setting.
  • 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
  • For patients participating in DCE-MRI assessments, any contraindication to MRI examination
  • For patients with advanced solid tumors or NHL participating in the PPI-effect assessment: Known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation
  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: NCT00854152

Locations
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, New York
New York, New York, United States, 10065
United States, Tennessee
Nashville, Tennessee, United States, 37203
United Kingdom
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Genentech
Investigators
Study Director: Mika Derynck, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00854152     History of Changes
Other Study ID Numbers: PIM4604g, MP00880
Study First Received: February 27, 2009
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
NHL
Tumors
Carcinogenic Tumors

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

ClinicalTrials.gov processed this record on July 31, 2014