A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered to Patients With Refractory Solid Tumors or Lymphoma
This study has been completed.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01226277
First received: October 20, 2010
Last updated: October 30, 2012
Last verified: October 2012
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Purpose
This is an open-label, multicenter, Phase I dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics (PK) of GDC-0917 in patients with refractory solid tumors or lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Cancers |
Drug: GDC-0917 |
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, Tolerability and Pharmacokinetics of GDC-0917 Administered Daily in Patients With Refractory Solid Tumors or Lymphoma |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Changes in vital signs, ECGs, and clinical laboratory results [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]
- Incidence and nature of dose-limiting toxicities and adverse events of special interest [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]
- Incidence, nature, and severity of all adverse events and serious adverse events [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetic parameters of GDC-0917 (including total exposure, maximum and minimum serum concentration, time to maximum observed plasma concentration, elimination of half-life, accumulation at steady-state) [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]
| Enrollment: | 42 |
| Study Start Date: | October 2010 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: GDC-0917
Oral repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically documented, locally advanced or metastatic solid tumors or lymphoma for which standard therapy either does not exist or has proven ineffective or intolerable
- Life expectancy >/= 12 weeks
- Adequate hematologic and end organ function
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use an effective form of contraception and to continue its use for the duration of the study.
Exclusion Criteria:
- Clinically significant history of chronic liver disease, active hepatic infection, evidence of hepatic cirrhosis or Grade >/= 2 liver dysfunction not due to hepatic metastases of cancer, current alcohol abuse, active infections with hepatitis B virus, or hepatitis C virus
- Grade >/= 2 fever or associated constitutional symptoms, or a clinically significant systemic infection within the last month
- Autoimmune disease
- History of clinically significant pulmonary disease
- Need for chronic and continuous systemic or topical corticosteroids or immunosuppressive therapy within 2 weeks prior to study entry or anticipated need of continuous systemic corticosteroids or immunosuppressive therapy during study participation.
- Allergy or hypersensitivity to components of the GDC-0917 formulation
- Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1
- Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1
- Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
- Prior anti-cancer therapy within 4 weeks before the first dose of study drug treatment in Cycle 1
- All acute drug-related toxicities must have resolved prior to study entry, except for alopecia and Grade 1 neuropathy.
- Current severe, uncontrolled systemic disease excluding cancer
- History of clinically significant cardiac dysfunction
- History of malabsorption or other condition that would interfere with enteral absorption
- Any history of active GI bleeding within the past 6 months prior to screening
- Known HIV infection
- Uncontrolled ascites, due to diseases other than cancer, requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment
- Pregnancy, lactation, breastfeeding or unwillingness to use birth control during the study and for 3 months after the last dose of GDC-0917
- Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226277
Locations
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Chia Portera, M.D., Ph.D. | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01226277 History of Changes |
| Other Study ID Numbers: | 4914g, GO01306 |
| Study First Received: | October 20, 2010 |
| Last Updated: | October 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013