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NCT02257424 · ClinicalTrials.gov registry record · Phase 1

Dabrafenib, Trametinib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma

A Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.

Completed
Registry status
Phase 1
Development phase
50
Enrollment target

NCT02257424: Completed Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.

NCT02257424 is a Phase 1 study that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02257424, a Phase 1 study, has completed, sponsored by Abramson Cancer Center at Penn Medicine.

COMPLETED
Registry status
Phase 1
Development phase
50 participants
Enrollment target

Study Summary

The primary purpose of this study is to determine the maximum tolerated dose (MTD) and preliminary safety of hydroxychloroquine (HCQ) when administered in conjunction with oral dabrafenib and trametinib (D+T) in patients with advanced BRAF mutant melanoma.

Primary Outcome

Phase 1: Maximum tolerated dose (MTD) = a) the dose producing Dose Limiting Toxicity (DLT) in 2/6 patients, or b) the dose level below the dose which produced DLT in ≥ 2/3 patients, or in ≥ 3/6 patients

Interventions

  • DRUG Trametinib 2 mg daily
  • DRUG hydroxychloroquine (HCQ)
  • DRUG dabrafenib 150 mg orally twice a day

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2014-10
Est. Completion 2021-10
Phase Phase 1

What the finished NCT02257424 record still lists

NCT02257424 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).

The record links to 0 conditions, and to 3 interventions - of which Trametinib 2 mg daily is the first listed.

NCT02257424 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02257424 about?

NCT02257424 is a clinical study titled "Dabrafenib, Trametinib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma". The primary purpose of this study is to determine the maximum tolerated dose (MTD) and preliminary safety of hydroxychloroquine (HCQ) when administered in conjunction with oral dabrafenib and trametinib (D+T) in patients with advanced BRAF mutant melanoma.

What is the current status of trial NCT02257424?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2014-10. Estimated completion is 2021-10.

What interventions are being tested in trial NCT02257424?

The interventions under investigation include: Trametinib 2 mg daily (DRUG), hydroxychloroquine (HCQ) (DRUG), dabrafenib 150 mg orally twice a day (DRUG).

Who is sponsoring clinical trial NCT02257424?

This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02257424's enrollment target sits among peer trials

50 973rd of 2000 higher than 984 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 NCT02257424, the US trial registry maintained by the National Library of Medicine. NCT02257424 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.