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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-20

Study Completion Date

2018-02-07

Brief Summary

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This open-label, multicenter, dose-escalation study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5509554 in participants with advanced solid tumors which are not amenable to standard treatment. In Part I (Dose Escalation), multiple ascending doses of RO5509554 will be administered as monotherapy in participants with solid tumors. Participants with locally advanced and/or metastatic ovarian (including fallopian tube) and breast carcinoma will receive multiple ascending doses of RO5509554 in combination with paclitaxel. In Part II (Expansion Cohort), RO5509554 will be administered as monotherapy to participants with locally advanced and/or metastatic Pigmented Villonodular Synovitis (PVNS)/Tenosynovial Giant Cell Tumor (TGCT), soft tissue sarcoma or malignant mesothelioma, ovarian (including fallopian tube), endometrial or breast cancer and pancreatic cancer. Participants with Human Epidermal Growth Factor Receptor 2 (HER2)/neu negative breast cancer will receive RO5509554 in combination with paclitaxel. Anticipated time on study treatment is until disease progression, unacceptable toxicity, death or participant refusal, whichever occurs first.

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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1 - Dose Escalation: RO5509554

Participants will receive a single, low dose of 100 milligrams (mg) RO5509554 in 7-day PK run-in period (Cycle 0), followed by dose escalation from Day 1 of Cycle 1. RO5509554 will be escalated as monotherapy in approximately 6 cohorts with dose increments between cohorts of up to 100 percent (%). The doses will be escalated further until MTD/OBD as single agent is reached.

Group Type EXPERIMENTAL

RO5509554

Intervention Type DRUG

RO5509554 will be administered Q2W, Q3W or initial biweekly followed by monthly maintenance as intravenous (IV) infusion until disease progression, unacceptable toxicity, death or participant refusal, whichever occurs first.

Part 1 - Dose Escalation: RO5509554 + Paclitaxel

RO5509554 will be administered in combination with a fixed dose of weekly (QW) paclitaxel (80 milligrams per square meter \[mg/m\^2\]). The starting dose for RO5509554 in combination with paclitaxel will be 2 dose levels below to that of the highest dose of monotherapy RO5509554. Escalation of RO5509554 in combination with QW paclitaxel will start in a standard 3 + 3 design until MTD/OBD as combination dose is reached. If the initial combination is not tolerated, further cohorts will be dosed with the same dose of paclitaxel and lower dose of RO5509554. If insufficient safety, pharmacokinetic or pharmacodynamic data have been collected at the MTD/OBD, up to an additional 4 participants may be enrolled at that dose level.

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

Paclitaxel, at a dose of 80 mg/m\^2 will be administered QW for up to 12 weeks.

RO5509554

Intervention Type DRUG

RO5509554 will be administered Q2W, Q3W or initial biweekly followed by monthly maintenance as intravenous (IV) infusion until disease progression, unacceptable toxicity, death or participant refusal, whichever occurs first.

Part 2 - Expansion Cohort: RO5509554

Participants will receive RO5509554 1000 mg Q2W, Q3W or initial biweekly followed by monthly maintenance.

Group Type EXPERIMENTAL

RO5509554

Intervention Type DRUG

RO5509554 will be administered Q2W, Q3W or initial biweekly followed by monthly maintenance as intravenous (IV) infusion until disease progression, unacceptable toxicity, death or participant refusal, whichever occurs first.

Part 2 - Expansion Cohort: RO5509554 + Paclitaxel

Participants will receive RO5509554 1000 mg Q2W in combination with a fixed dose of QW paclitaxel (80 mg/m\^2).

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

Paclitaxel, at a dose of 80 mg/m\^2 will be administered QW for up to 12 weeks.

RO5509554

Intervention Type DRUG

RO5509554 will be administered Q2W, Q3W or initial biweekly followed by monthly maintenance as intravenous (IV) infusion until disease progression, unacceptable toxicity, death or participant refusal, whichever occurs first.

Interventions

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Paclitaxel

Paclitaxel, at a dose of 80 mg/m\^2 will be administered QW for up to 12 weeks.

Intervention Type DRUG

RO5509554

RO5509554 will be administered Q2W, Q3W or initial biweekly followed by monthly maintenance as intravenous (IV) infusion until disease progression, unacceptable toxicity, death or participant refusal, whichever occurs first.

Intervention Type DRUG

Other Intervention Names

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RG7155

Eligibility Criteria

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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

* Participants with histologically proven Hepatocellular Carcinoma (HC), Non Small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), gastric cancer, malignant melanoma, nonmetastatic and locally controlled PVNS/TGCT
* Participants with known auto-immune disease
* Known or suspected central nervous system (CNS) metastases including leptomeningeal metastasis; participants with radiologically stable, asymptomatic previously irradiated lesion are eligible provided participant is greater than or equal to (\>/=) 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
* Prior corticosteroids as anti-cancer therapy within minimum of 14 days of first receipt of study drug
* Poorly controlled type 1 or type 2 diabetes mellitus
* Prior toxicities from chemotherapy or radiotherapy which have not regressed to Grade less than or equal to (\</=) 1 severity National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 or later versions
* Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (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
* Participant requires high dose corticosteroid treatment ( i.e. greater than (\>) 20 mg dexamethasone a day or equivalent for \> 7 consecutive days)
* Any surgical procedure, including the required baseline tumor biopsy, within less than 14 days of first receipt of study drug. Major surgery within 28 days of first receipt of study drug
* Pregnant or lactating women

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No