A Study of RO5509554 as Monotherapy and in Combination With Paclitaxel in Patients With Advanced 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:
NCT01494688
First received: December 2, 2011
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
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 |
|---|---|---|
|
Neoplasms |
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 ]
| Estimated Enrollment: | 105 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (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
|
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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494688
Contacts
| Contact: Reference Study ID Number: BP27772 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | global.rochegenentechtrials@roche.com |
Locations
| France | |
| Recruiting | |
| Bordeaux, France, 33076 | |
| Active, not recruiting | |
| Lyon, France, 69373 | |
| Active, not recruiting | |
| Paris, France, 75231 | |
| Active, not recruiting | |
| Saint Herblain, France, 44805 | |
| Active, not recruiting | |
| Toulouse, France, 31059 | |
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: | NCT01494688 History of Changes |
| Other Study ID Numbers: | BP27772, 2011-003394-28 |
| Study First Received: | December 2, 2011 |
| Last Updated: | May 23, 2013 |
| Health Authority: | France: AFSSAPS |
Additional relevant MeSH terms:
|
Neoplasms Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013