A Study of RO5509554 as Monotherapy and in Combination With Paclitaxel in Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: December 2, 2011
Last updated: July 1, 2016
Last verified: July 2016
This open-label, multicenter, dose-escalation study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5509554 in patients with advanced solid tumors which are not amenable to standard treatment. In Part I, multiple ascending doses of RO5509554 will be administered as monotherapy in patients with solid tumors. Patients with locally advanced and/or metastatic ovarian and breast carcinoma will receive multiple ascending doses of RO5509554 in combination with paclitaxel. In Part II, RO5509554 will be administered as monotherapy to patients with pigmented tenosynovial giant cell tumor (PVNS), tenosynovial giant cell tumor (TGCT), ovarian cancer or breast cancer. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Condition Intervention Phase
Drug: RO5509554
Drug: paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Multicenter, Dose Escalation Phase Ia/Ib Study With Expansion Phase to Evaluate Safety, Pharmacokinetics and Activity of RO5509554, Administered as an Intravenous Infusion as Monotherapy and in Combination With Paclitaxel in Patients With Advanced Solid Tumors.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Part 1: Determination of maximum tolerated dose (MTD)/optimal biological dose [ Time Frame: approximately 15 months ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Plasma concentrations of RO5509554 [ Time Frame: Pre-dose, end of infusion and 2, 3, 4, 5, 6, 24, 72 or 96, and 168 hours post-dose Cycles 1-4, pre-dose and end of infusion on Day 1 every following cycle ] [ Designated as safety issue: No ]
  • Part 2: Clinical response: Tumor assessments according to RECIST criteria [ Time Frame: approximately 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in pharmacodynamic markers in surrogate/tumor tissue (skin/tumor biopsies) [ Time Frame: From baseline to Day 8 Cycle 2 ] [ Designated as safety issue: No ]
  • Part 1: Change in pharmacodynamic markers assessed by DCE-Ultra-Sound/FDG positron emission tomography [ Time Frame: From baseline to Day 1 Cycle 3 ] [ Designated as safety issue: No ]
  • Part 1: Recommended phase II dosage/schedule [ Time Frame: approximately 15 months ] [ Designated as safety issue: No ]
  • Part 1: Clinical response: Tumor assessments according to RECIST criteria [ Time Frame: approximately 15 months ] [ Designated as safety issue: No ]

Enrollment: 217
Study Start Date: December 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 A Drug: RO5509554
Multiple ascending doses
Experimental: Part 1 B Drug: RO5509554
Multiple ascending doses
Drug: paclitaxel
standard chemotherapy
Experimental: Part 2 Drug: RO5509554
Multiple doses


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically confirmed advanced and/or metastatic solid tumors which are not amenable to standard therapy, with exceptions as defined in exclusion criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Measurable disease according to RECIST criteria version 1.1
  • Adequate bone marrow, cardiac, liver and renal function

Exclusion Criteria:

  • Known or suspected central nervous system (CNS) metastases including leptomeningeal metastasis; patients with radiologically stable, asymptomatic previously irradiated lesion are eligible provided patients is >/= 4 weeks beyond completing cranial irradiation and >/= 3 weeks of corticosteroid therapy
  • Significant, uncontrolled concomitant diseases, including significant cardiovascular or pulmonary disease
  • Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy for bone pain), any investigational agent or immunotherapy within 28 days of first receipt of study drug
  • Poorly controlled type 1 or type 2 diabetes
  • Prior toxicities from chemotherapy or radiotherapy which have not regressed to Grade </=1 severity (NCI-CTCAE version 4.03 or later versions
  • Known HIV, HBV and HCV infection
  • Pulmonary embolism or any other thrombo-embolic event within 6 months prior to study entry
  • History of hematological malignancy within the last 5 years prior to study entry
  • Patient requires high dose corticosteroid treatment ( i.e. > 20 mg dexamethasone a day or equivalent for > 7 consecutive days)
  • Pregnant or lactating women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494688

United States, New York
New York, New York, United States, 10065
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Bordeaux, France, 33076
Lyon, France, 69373
Paris, France, 75231
Saint Herblain, France, 44805
Toulouse, France, 31059
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01494688     History of Changes
Other Study ID Numbers: BP27772  2011-003394-28 
Study First Received: December 2, 2011
Last Updated: July 1, 2016
Health Authority: France: AFSSAPS

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2016