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NCT01470209 · ClinicalTrials.gov registry record · Phase 1

A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies

A Phase 1 study, sponsored by Emory University.

Completed
Registry status
Phase 1
Development phase
43
Enrollment target

NCT01470209: Completed Phase 1 study, sponsored by Emory University.

NCT01470209 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01470209, a Phase 1 study, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 1
Development phase
43 participants
Enrollment target

Study Summary

This study will assess the safety of combining two agents (everolimus and BKM120) for the treatment of advanced cancer arising from solid organ in patients who are no longer benefiting from or unable to withstand standard treatment of these conditions.

Primary Outcome

i. Grade 4 hematologic toxicity (excluding anemia) lasting more than 7 days ii. Grade 3 anemia lasting more than 7 days or requiring blood transfusion iii. Grade 4 anemia iv. Grade ≥ 3 febrile neutropenia of any duration v. Grade ≥ 3 nausea and or vomiting lasting more than 72 hours in spite of standard supportive therapy vi. Grade ≥ 3 non-hematologic toxicity (excluding alopecia)

Interventions

  • DRUG Everolimus
  • DRUG BKM120

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2012-01
Est. Completion 2017-05
Phase Phase 1
Emory University

1,208 total trials

What the finished NCT01470209 record still lists

NCT01470209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).

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

NCT01470209 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01470209 about?

NCT01470209 is a clinical study titled "A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies". This study will assess the safety of combining two agents (everolimus and BKM120) for the treatment of advanced cancer arising from solid organ in patients who are no longer benefiting from or unable to withstand standard treatment of these conditions.

What is the current status of trial NCT01470209?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2012-01. Estimated completion is 2017-05.

What interventions are being tested in trial NCT01470209?

The interventions under investigation include: Everolimus (DRUG), BKM120 (DRUG).

Who is sponsoring clinical trial NCT01470209?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01470209's enrollment target sits among peer trials

43 1100th of 2000 higher than 896 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 NCT01470209, the US trial registry maintained by the National Library of Medicine. NCT01470209 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.