Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01494688 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 217 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (262% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01494688 record still lists
NCT01494688 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (262% higher).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT01494688 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01494688's enrollment target sits among peer trials
217 240th of 2000 higher than 1,758 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05079282 · 217 participants · Phase 1
Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
- NCT05470439 · 217 participants · NA
My Interprofessional Care Team for Adherence and Research Engagement Disparities
- NCT05981703 · 217 participants · Phase 1
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
- NCT06342258 · 217 participants · Phase 1
COES: Curing Order Effects on Sealants
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI