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An Open-label, Multi-center, Dose Escalation Phase I Study of Single Agent RO5520985, Administered as an Intravenous Infusion in Patients With Locally Advanced or Metastatic Solid Tumors.


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

Thank you

Trial Information

An Open-label, Multi-center, Dose Escalation Phase I Study of Single Agent RO5520985, Administered as an Intravenous Infusion in Patients With Locally Advanced or Metastatic Solid Tumors.


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Patients with histologically or cytologically confirmed locally advanced or
metastatic, non-resectable solid tumors whose disease has progressed despite standard
therapy or for whom no standard therapy exists

- Measurable disease as determined by RECIST 1.1

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

- Adequate hematological function

- Adequate liver function

- Adequate renal function

- Adequate coagulation

- Adequate cardiovascular function

- Recovery from all reversible adverse events of previous anti-cancer therapies to
baseline or CTCAE G 1, except for alopecia (any grade) and < or = G 2 sensory
peripheral neuropathy

Exclusion Criteria:

- Patients with primary CNS tumors or CNS tumor involvement. Patients with metastatic
CNS tumors may participate in this trial under conditions defined by protocol

- Patients with squamous non-small cell lung cancer histology

- Prior treatment with anti-angiogenic agents targeting VEGF/Ang-1/Ang-2/PIGF and its
receptors within 6 months prior to study drug administration

- Prior systemic anti-cancer therapy within the following timeframes: a) cyclical
chemotherapy within a period of time that is shorter than the cycle length for the
treatment used prior to study drug administration; b) biologic therapy or continuous
or intermittent treatment with small molecule therapeutics (targeted therapies)
within 4 weeks or < or = 5 half-lives of the drug concerned (whichever is shorter)
prior to study drug administration

- Treatment with any other investigational agents within less than the cycle length
used for that treatment or within 4 weeks (whichever is shorter) prior to study drug
administration

- Major surgery within 4 weeks prior to study drug administration

- Significant cardiovascular/cerebrovascular disease within 6 months prior to study
drug administration

- Known HIV infection or known active hepatitis B or hepatitis C virus infection

- Pregnant or nursing women

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicities/maximum tolerated dose

Outcome Time Frame:

approximately 2 years

Safety Issue:

Yes

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Spain: Ministry of Health

Study ID:

BP28179

NCT ID:

NCT01688206

Start Date:

October 2012

Completion Date:

January 2015

Related Keywords:

  • Neoplasms
  • Neoplasms

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