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NCT01494688 · ClinicalTrials.gov registry record · Phase 1
A Study of RO5509554 as Monotherapy and in Combination With Paclitaxel in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 217
- Enrollment target
NCT01494688 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 217 participants.
The verdict
NCT01494688, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 217 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Paclitaxel
- DRUG RO5509554
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2011-12-20 |
| Est. Completion | 2018-02-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01494688
The ClinicalTrials.gov registry entry for NCT01494688 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 217 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT01494688 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01494688 about?
NCT01494688 is a clinical study titled "A Study of RO5509554 as Monotherapy and in Combination With Paclitaxel in Participants With Advanced Solid Tumors". 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 wil...
What is the current status of trial NCT01494688?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 217 participants. The study started on 2011-12-20. Estimated completion is 2018-02-07.
What interventions are being tested in trial NCT01494688?
The interventions under investigation include: Paclitaxel (DRUG), RO5509554 (DRUG).
Who is sponsoring clinical trial NCT01494688?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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