Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01654965 · ClinicalTrials.gov registry record · Phase 1
Tivantinib and Topotecan Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01654965: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01654965 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01654965, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of tivantinib and topotecan hydrochloride in treating patients with advanced or metastatic solid tumors. Tivantinib and topotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by CTCAE), attribution, time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by course.
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Pegfilgrastim
- OTHER Pharmacological Study
- DRUG Topotecan Hydrochloride
- DRUG Tivantinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2012-07-24 |
| Est. Completion | 2018-03-29 |
| Phase | Phase 1 |
What the finished NCT01654965 record still lists
NCT01654965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01654965 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01654965 about?
NCT01654965 is a clinical study titled "Tivantinib and Topotecan Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors". This phase I trial studies the side effects and best dose of tivantinib and topotecan hydrochloride in treating patients with advanced or metastatic solid tumors. Tivantinib and topotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
What is the current status of trial NCT01654965?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2012-07-24. Estimated completion is 2018-03-29.
What interventions are being tested in trial NCT01654965?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Pegfilgrastim (BIOLOGICAL), Pharmacological Study (OTHER), Topotecan Hydrochloride (DRUG), Tivantinib (DRUG).
Who is sponsoring clinical trial NCT01654965?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01654965's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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
- NCT02090140 · 17 participants · NA
Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects
- NCT03317860 · 17 participants · NA
Improving Measurement and Treatment of Post-stroke Neglect
- NCT04356469 · 17 participants · Phase 2
TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Non-Malignant Hematological Disorders in Children
- NCT04414046 · 17 participants · Phase 2
TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Primary Immunodeficiency and Inherited Metabolic Disorders in Children
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