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NCT01497444 · ClinicalTrials.gov registry record · Phase 1

Sorafenib Tosylate and Hypoxia-Activated Prodrug TH-302 in Treating Patients With Advanced Kidney Cancer or Liver Cancer That Cannot Be Removed By Surgery

A Phase 1 study, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT01497444: Completed Phase 1 study, sponsored by Alliance for Clinical Trials in Oncology.

NCT01497444 is a Phase 1 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01497444, a Phase 1 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth by blocking blood flow to the tumor. Drugs used in chemotherapy, such as hypoxia-activated prodrug TH-302, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib tosylate together with hypoxia-activated prodrug TH-302 may kill more tumor cells. PURPOSE: This phase I/II trial studies the side effects and best dose of giving sorafenib tosylate together with hypoxia-activated prodrug TH-302 and to see how well they work in treating patients with advanced kidney cancer or liver cancer that cannot be removed by surgery.

Interventions

  • DRUG sorafenib tosylate
  • DRUG hypoxia-activated prodrug TH-302

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2012-05
Est. Completion 2019-11-01
Phase Phase 1

What the finished NCT01497444 record still lists

NCT01497444 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 2 interventions - of which sorafenib tosylate is the first listed.

NCT01497444 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01497444 about?

NCT01497444 is a clinical study titled "Sorafenib Tosylate and Hypoxia-Activated Prodrug TH-302 in Treating Patients With Advanced Kidney Cancer or Liver Cancer That Cannot Be Removed By Surgery". RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth by blocking blood flow to the tumor. Drugs used in chemotherapy, such as hypoxia-activated prodrug TH-302, work in different ways to stop the growth of tumor cells, either by killi...

What is the current status of trial NCT01497444?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-05. Estimated completion is 2019-11-01.

What interventions are being tested in trial NCT01497444?

The interventions under investigation include: sorafenib tosylate (DRUG), hypoxia-activated prodrug TH-302 (DRUG).

Who is sponsoring clinical trial NCT01497444?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01497444's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 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 NCT01497444, the US trial registry maintained by the National Library of Medicine. NCT01497444 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.