Trials Sponsors Conditions Drugs Pricing

Conditions

Non-Hodgkin's Lymphoma, Solid Tumor

Keywords

solid cancers

Outcome Measures

Primary Outcomes (1)

Incidence of dose limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0349
Up to 30 days

Secondary Outcomes (2)

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

Study Arms (1)

A

EXPERIMENTAL

Drug: GDC-0349

Interventions

GDC-0349Drug

Oral escalating dose

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Genentech, Inc.
Industrylead

Study Sites (2)

Scottsdale, Arizona, 85258, United States

Toronto, Ontario, M5G 2M9, Canada

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

GDC-0349

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

Scott Holden, M.D.
Genentech, Inc.
STUDY DIRECTOR

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 19, 2011

Study Start

June 2011

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

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.
+4 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations