deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT01100463

Study of 0.1% Uracil Topical Cream (UTC) for the Prevention of Hand-Foot Syndrome

A Phase 1-2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of 0.1% Uracil Topical Cream (UTC) in the Prevention of Hand-Foot Syndrome (HFS) in Patients With Metastatic Breast Cancer Treated With Capecitabine

Sponsor: Nanometics (d.b.a. PHD Biosciences)

Conditions Breast Cancer Palmar-Plantar Erythrodysesthesia
Interventions 0.1% Uracil Cream Cream
Updated 9 times since 2017 Last updated: Oct 5, 2019 Started: Apr 30, 2010 Primary completion: Aug 31, 2011 Completion: Sep 30, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Breast Cancer and Palmar-Plantar Erythrodysesthesia and is currently completed. Nanometics (d.b.a. PHD Biosciences) leads this study, which shows 9 recorded versions since 2010 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotUnknown Status~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotUnknown Status~Jun 2018 – ~Aug 2019 · 14 months · monthly snapshotUnknown Status~Aug 2019 – ~Nov 2019 · 3 months · monthly snapshotCompleted~Nov 2019 – ~Mar 2020 · 4 months · monthly snapshotCompleted~Mar 2020 – ~Jan 2021 · 10 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

9 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  4. Mar 2020 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

  5. Nov 2019 — Mar 2020 [monthly]

    Completed PHASE1_PHASE2

▶ Show 4 earlier versions

  1. Aug 2019 — Nov 2019 [monthly]

    Completed PHASE1_PHASE2

    Status: Unknown Status → Completed

  2. Jun 2018 — Aug 2019 [monthly]

    Unknown Status PHASE1_PHASE2

  3. Feb 2017 — Jun 2018 [monthly]

    Unknown Status PHASE1_PHASE2

  4. Jan 2017 — Feb 2017 [monthly]

    Unknown Status PHASE1_PHASE2

    First recorded

Apr 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Nanometics (d.b.a. PHD Biosciences)
Data source: Nanometics (d.b.a. PHD Biosciences)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations