Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma

• ClinicalTrials.gov Identifier: NCT01356173
• Recruitment Status: Completed
• First Posted: May 19, 2011
• Last Update Posted: November 2, 2016
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Tracking Information

• First Submitted Date: May 17, 2011
• First Posted Date: May 19, 2011
• Last Update Posted Date: November 2, 2016
• Study Start Date: June 2011
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 18, 2011): Incidence of dose limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0349 [ Time Frame: Up to 30 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 18, 2011)

• Incidence of adverse events by NCI CTCAE v4.0 grade and associated dose of GDC-0349 [ Time Frame: Up to 2 years ]
• Incidence of Grade 3 and 4 abnormalities in safety related laboratory parameters and associated dose of GDC-0349 [ Time Frame: Up to 30 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma
• Official Title: 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
• Brief Summary: This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetic (PK) of GDC-0349 administered once daily (QD), orally (PO).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-Hodgkin's Lymphoma, Solid Tumor

Intervention

Drug: GDC-0349

Oral escalating dose

Study Arms

Experimental: A

Intervention: Drug: GDC-0349

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 9, 2012): 10
• Original Estimated Enrollment (submitted: May 18, 2011): 56
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT01356173
• Other Study ID Numbers: MKI4956g; MP00807 ( Other Identifier: Hoffmann-La Roche )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Genentech, Inc.
• Original Responsible Party: Disclosures Group, Genentech, Inc.
• Current Study Sponsor: Genentech, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Scott Holden, M.D.; Genentech, Inc.

• PRS Account: Genentech, Inc.
• Verification Date: November 2016