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NCT01611857 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Trial of Tivantinib With FOLFOX for the Treatment of Advanced Solid Tumors and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal Junction or Stomach
A Phase 1 study of GastroEsophageal Cancer and Malignant Solid Tumour, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 9
- Study locations
NCT01611857: Completed Phase 1 study of GastroEsophageal Cancer and Malignant Solid Tumour, sponsored by SCRI Development Innovations.
NCT01611857 is a Phase 1 study of GastroEsophageal Cancer and Malignant Solid Tumour that has completed, run by SCRI Development Innovations. The registered enrollment target is 49 participants, below the 495-participant average among 23 other GastroEsophageal Cancer trials with a reported enrollment target (90% lower). The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01611857, a Phase 1 study of GastroEsophageal Cancer and Malignant Solid Tumour, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients with advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined; in Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is hypothesized that the response rate (RR) will be improved from 45% to at least 65% under this regimen.
Primary Outcome
Using a standard 3+3 design participants were enrolled in dose-escalating cohorts to determine the maximum tolerated dose (MTD) of tivantinib when given with FOLFOX (5-FU 400 mg/m\^2, continuous IV 5-FU 2400 mg/m\^2 over 46 hours, leucovorin 400 mg/m\^2 IV, and oxaliplatin 85 mg/m\^2). MTD is defined as the highest dose level at which no more than 1 of 6 patients experiences a DLT, assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.
Conditions Studied
Interventions
- DRUG FOLFOX
- DRUG Tivantinib
Study Locations (9)
Florida
- Florida Cancer Specialists-South - Fort Myers
- Florida Cancer Specialists-Sarasota - Sarasota
- Florida Cancer Specialists-North - St. Petersburg
Tennessee
- Tennessee Oncology - Chattanooga - Chattanooga
- Tennessee Oncology, PLLC - Nashville
Connecticut
- Yale University School of Medicine - New Haven
Oklahoma
- Oklahoma University - Oklahoma City
South Carolina
- South Carolina Oncology Associates - Columbia
Texas
- Center for Cancer and Blood Disorders - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
What the finished NCT01611857 record still lists
NCT01611857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 495-participant average among 23 other GastroEsophageal Cancer trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with GastroEsophageal Cancer appearing as the primary indexed condition, and to 2 interventions - of which FOLFOX is the first listed.
NCT01611857 lists 9 locations in 6 states (Florida, Tennessee, Connecticut).
Frequently Asked Questions
What is clinical trial NCT01611857 about?
NCT01611857 is a clinical study titled "Phase I/II Trial of Tivantinib With FOLFOX for the Treatment of Advanced Solid Tumors and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal Junction or Stomach". This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients with advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined; in Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is hypothesized that the respo...
What is the current status of trial NCT01611857?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2012-07. Estimated completion is 2015-08.
What conditions does trial NCT01611857 study?
This clinical trial studies the following conditions: GastroEsophageal Cancer, Malignant Solid Tumour.
What interventions are being tested in trial NCT01611857?
The interventions under investigation include: FOLFOX (DRUG), Tivantinib (DRUG).
Who is sponsoring clinical trial NCT01611857?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01611857 being conducted?
This trial has 9 study locations across Connecticut, Florida, Oklahoma, South Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01611857's enrollment target sits among peer trials
49 10th of 23 higher than 14 of 23 other GastroEsophageal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other GastroEsophageal Cancer 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.
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