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NCT01093092 · ClinicalTrials.gov registry record · Phase 1

Calcitriol, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors That Cannot Be Removed by Surgery

A Phase 1 study, sponsored by Roswell Park Cancer Institute.

Terminated
Registry status
Phase 1
Development phase
14
Enrollment target

NCT01093092: Clinical Trial Phase 1 study, sponsored by Roswell Park Cancer Institute.

NCT01093092 is a Phase 1 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01093092, a Phase 1 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.

TERMINATED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of calcitriol when given with cisplatin and gemcitabine hydrochloride in treating patients with advanced solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Calcitriol may stop the growth of tumor cells by blocking blood flow to the tumor. Calcitriol may also help cisplatin and gemcitabine hydrochloride kill more tumor cells by making them more sensitive to the drug.

Primary Outcome

A standard 3+3 with de-escalation will be used to estimate the MTD.

Interventions

  • DRUG Cisplatin
  • DRUG Gemcitabine Hydrochloride
  • OTHER Pharmacological Study
  • DIETARY_SUPPLEMENT Calcitriol

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2011-09
Est. Completion 2015-11
Phase Phase 1
Roswell Park Cancer Institute

365 total trials

Why NCT01093092 stopped before completion

NCT01093092 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.

NCT01093092 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01093092 about?

NCT01093092 is a clinical study titled "Calcitriol, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors That Cannot Be Removed by Surgery". This phase I trial studies the side effects and best dose of calcitriol when given with cisplatin and gemcitabine hydrochloride in treating patients with advanced solid tumors that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in diff...

What is the current status of trial NCT01093092?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2011-09. Estimated completion is 2015-11.

What interventions are being tested in trial NCT01093092?

The interventions under investigation include: Cisplatin (DRUG), Gemcitabine Hydrochloride (DRUG), Pharmacological Study (OTHER), Calcitriol (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01093092?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01093092's enrollment target sits among peer trials

14 1844th of 2000 higher than 154 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

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Source: ClinicalTrials.gov NCT01093092, the US trial registry maintained by the National Library of Medicine. NCT01093092 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.