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An Open-label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0575 Administered Alone and in Combination With Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Solid Tumour

Thank you

Trial Information

An Open-label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0575 Administered Alone and in Combination With Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- 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

- Adequate hematologic, liver and renal function

Exclusion Criteria:

- History of prior significant toxicity from a same class of agents as GDC-0575 or
gemcitabine requiring discontinuation of treatment

- All acute toxicities related to prior therapy must have resolved prior to study
entry, except for alopecia and mild neuropathy

- Current severe, uncontrolled systemic disease (including but not limited to
clinically significant cardiovascular, pulmonary, or renal disease or ongoing or
active infection) excluding cancer

- History of significant cardiac dysfunction

- History of malabsorption or other condition that would interfere with enteral
absorption

- Known HIV infection

- Pregnancy, lactation or breastfeeding

- Known brain metastases that are untreated, symptomatic, or require therapy to control
symptoms

- Current use of alpha-adrenegic receptor blockers

- For Combination Arm only:

- Any contraindication to gemcitabine therapy

- More than two regimens of cytotoxic chemotherapy for the treatment of locally
advanced or metastatic cancer

- History of receiving high-dose chemotherapy requiring bone marrow or stem cell
support

- History of receiving radiation to more than 25% of bone marrow-bearing areas

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety: Incidence of adverse events

Outcome Time Frame:

approximately 1 year

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GP28153

NCT ID:

NCT01564251

Start Date:

March 2012

Completion Date:

October 2014

Related Keywords:

  • Lymphoma, Solid Tumour
  • Lymphoma
  • Neoplasms

Name

Location

Nashville, Tennessee  37203-1632
Flint, Michigan  48532