Know Cancer

or
forgot password

Phase Ia/Ib, Open-label, Multicenter, Dose-escalation Study Followed by an Extension Phase to Evaluate Safety, Pharmacokinetics and Activity of RO5479599, a Glycoengineered Antibody Against HER3, Administered Either Alone (Part A) or in Combination With Cetuximab (Part B) or in Combination With Erlotininb (Part C) in Patients With Metastatic and/or Locally Advanced Malignant HER3-positive Solid Tumors of Ephitelian Cell Origin


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

Thank you

Trial Information

Phase Ia/Ib, Open-label, Multicenter, Dose-escalation Study Followed by an Extension Phase to Evaluate Safety, Pharmacokinetics and Activity of RO5479599, a Glycoengineered Antibody Against HER3, Administered Either Alone (Part A) or in Combination With Cetuximab (Part B) or in Combination With Erlotininb (Part C) in Patients With Metastatic and/or Locally Advanced Malignant HER3-positive Solid Tumors of Ephitelian Cell Origin


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- European Cooperative Oncology Group (ECOG) performance status 0-2

- Histologically confirmed metastatic and/or locally advanced malignant HER3-expressing
solid tumors of epithelian origin

- Availability of tissue and willingness to perform fresh pretreatment biopsies

- Patients for whom no standard therapy exists

- All acute toxic effects of any prior radiotherapy, chemotherapy or surgical procedure
must have resolved to Grade neuropathy

- Adequate hematological, renal and liver function

- Patient's with Gilbert's syndrome will be eligible for the study

- Part B extension cohort: In addition to the above inclusion criteria, patients will
be eligible if they have metastatic and/or locally advanced non-small cell lung
cancer or squamous cell carcinoma of the head and neck or colorectal cancer (wild
type with positive EGFR expression)

- Part C extension cohort: In addition to the above inclusion criteria, patients will
be eligible only if they have metastatic and/or locally advanced non-small cell lung
cancer or pancreatic cancer

Exclusion Criteria:

- Known or clinically suspected CNS primary tumors or metastases including
leptomeningeal metastases, except for previously treated CNS metastases that are
asymptomatic and did not require steroids or enzyme-inducing anticonvulsants in the
last 14 days

- Evidence of significant uncontrolled concomitant diseases or disorders

- Active or uncontrolled infections

- Known HIV infection

- Therapy with antibody or immunotherapy concurrently or within 14 days prior to first
dose of study drug

- Regular immunosuppressive therapy

- Concurrent high dose of systemic corticosteroids (> 20 mg/day dexamethasone or
equivalent for > 7 consecutive days)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety (Part A, including maximum tolerated dose): Incidence of adverse events

Outcome Time Frame:

72 weeks

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

The Netherlands: Central Committee on Research involving Human Subjects

Study ID:

BP27771

NCT ID:

NCT01482377

Start Date:

December 2011

Completion Date:

July 2014

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location