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

February 27, 2009
July 21, 2014
March 2009
August 2014   (final data collection date for primary outcome measure)
  • 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 ]
  • Occurrence of adverse events [ Time Frame: Length of study ]
  • Occurrence of dose-limiting toxicities [ Time Frame: Length of study ]
  • PK parameters after doses of GDC-0980 [ Time Frame: Length of study ]
Complete list of historical versions of study NCT00854152 on ClinicalTrials.gov Archive Site
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 ]
  • Cmax and AUC under fed and fasting conditions [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
A Study Evaluating GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma, Solid Cancers
Drug: GDC-0980
Escalating repeating dose
Experimental: 1
Intervention: Drug: GDC-0980
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
121
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00854152
PIM4604g, MP00880
Not Provided
Genentech
Genentech
Not Provided
Study Director: Mika Derynck, M.D. Genentech
Genentech
July 2014

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