Trial record 1 of 1 for:
BP27771
A Study of RO5479599 Alone or in Combination With Cetuximab or Erlotinib in Patients With Metastatic and/or Locally Advanced Malignant HER3-Positive Solid Tumors
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01482377
First received: November 28, 2011
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This multicenter, open-label, 3-Part dose-escalating study will evaluate the safety, pharmacokinetics and efficacy of RO5479599, alone or in combination with cetuximab or Erlotinib, in patients with metastatic and/or locally advanced malignant HER3-positive solid tumors. Cohorts of patients will receive escalating doses of intravenous RO5479599 as monotherapy (Part A) or in combination with cetuximab (Part B) or erlotinib (Part C). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
In an imaging substudy, patients will receive one or two doses of zirconium-89-labeled RO5479599 in addition to unlabeled RO5479599 to evaluate the in vivo biodistribution and organ pharmacokinetics of RO5479599.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: RO5479599 Drug: cetuximab Drug: erlotinib Drug: zirconium-89-labeled RO5479599 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Safety (Part A, including maximum tolerated dose): Incidence of adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
- Safety (Part B and C): Incidence of adverse events [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
- Pharmacokinetics (Parts A, B and C): Area under the concentration - time curve [ Time Frame: 200 weeks ] [ Designated as safety issue: No ]
- IMG Substudy: In vivo biodistribution as determined by positron emission tomography (PET) scan [ Time Frame: up to Day 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Part A: Recommended phase II dose (RPTD) in monotherapy [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
- Part B: Recommended phase II dose in combination with cetuximab [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- Part C: Recommended phase II dose in combination with erlotinib [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- Objective response rate (ORR), tumor assessments according to RECIST criteria [ Time Frame: 200 weeks ] [ Designated as safety issue: No ]
- Disease control rate (SD) [ Time Frame: 200 weeks ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: 200 weeks ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 200 weeks ] [ Designated as safety issue: No ]
- IMG Substudy: Target saturation by RO5479599, defined as decrease in tissue uptake of radioactivity concentration [ Time Frame: up to Day 8 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 105 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: RO5479599
Cohorts receiving multiple escalating doses intravenously
|
| Experimental: B |
Drug: RO5479599
Cohorts receiving multiple escalating doses intravenously
Drug: cetuximab
standard doses
|
| Experimental: C |
Drug: RO5479599
Cohorts receiving multiple escalating doses intravenously
Drug: erlotinib
standard doses
|
| Experimental: IMG Substudy |
Drug: RO5479599
Cohorts receiving multiple escalating doses intravenously
Drug: zirconium-89-labeled RO5479599
single dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 </= 1, except for alopecia and Grade 2 peripheral 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482377
Contacts
| Contact: Please reference Study ID Number: BP27771 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Denmark | |
| Recruiting | |
| København, Denmark, 2100 | |
| Netherlands | |
| Recruiting | |
| Amsterdam, Netherlands, 1066 CX | |
| Recruiting | |
| Groningen, Netherlands, 9713 GZ | |
| Recruiting | |
| Rotterdam, Netherlands, 3075EA | |
| Recruiting | |
| Utrecht, Netherlands, 3584 CX | |
| Spain | |
| Active, not recruiting | |
| Barcelona, Spain, 08003 | |
| Recruiting | |
| Valencia, Spain, 46010 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01482377 History of Changes |
| Other Study ID Numbers: | BP27771, 2011-002698-53 |
| Study First Received: | November 28, 2011 |
| Last Updated: | May 7, 2013 |
| Health Authority: | The Netherlands: Central Committee on Research involving Human Subjects |
Additional relevant MeSH terms:
|
Neoplasms Cetuximab Erlotinib Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013