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NCT01688973 · ClinicalTrials.gov registry record · Phase 2

Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
55
Enrollment target

NCT01688973: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT01688973 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01688973, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
55 participants
Enrollment target

Study Summary

This randomized phase II trial studies how well tivantinib with or without erlotinib hydrochloride works in treating patients with metastatic or locally advanced kidney cancer that cannot be removed by surgery. Tivantinib and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Primary Outcome

Best Response is calculated from the sequence of objective statuses. CR: Two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. PR: Two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR. Stable/no response: At least one objective status of stable/no response documented at least 6 weeks after registration and before p

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Erlotinib Hydrochloride
  • DRUG Tivantinib

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2012-08-20
Est. Completion 2017-04-30
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01688973 record still lists

NCT01688973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).

The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01688973 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01688973 about?

NCT01688973 is a clinical study titled "Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery". This randomized phase II trial studies how well tivantinib with or without erlotinib hydrochloride works in treating patients with metastatic or locally advanced kidney cancer that cannot be removed by surgery. Tivantinib and erlotinib hydrochloride may stop the growth of tumor cells by blocking som...

What is the current status of trial NCT01688973?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2012-08-20. Estimated completion is 2017-04-30.

What interventions are being tested in trial NCT01688973?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Erlotinib Hydrochloride (DRUG), Tivantinib (DRUG).

Who is sponsoring clinical trial NCT01688973?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01688973's enrollment target sits among peer trials

55 1153rd of 2000 higher than 841 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01688973, the US trial registry maintained by the National Library of Medicine. NCT01688973 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.