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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumour, Non-Hodgkin's Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Up to 30 days

Safety Issue:

No

Principal Investigator

Scott Holden, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

MKI4956g

NCT ID:

NCT01356173

Start Date:

June 2011

Completion Date:

December 2012

Related Keywords:

  • Solid Tumour, Non-Hodgkin's Lymphoma
  • solid cancers
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Neoplasms

Name

Location

Phoenix, Arizona  85012