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NCT03897036 · ClinicalTrials.gov registry record · Phase 1

Treatment Duration Increment and Pharmacodynamic Study of CX-4945 in Patients With Basal Cell Carcinoma (BCC)

A Phase 1 study, sponsored by Senhwa Biosciences.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target

NCT03897036: Completed Phase 1 study, sponsored by Senhwa Biosciences.

NCT03897036 is a Phase 1 study that has completed, run by Senhwa Biosciences. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03897036, a Phase 1 study, has completed, sponsored by Senhwa Biosciences.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target

Study Summary

This study is to determine the recommended phase II dose (RP2D) and schedule of CX-4945 when administered orally twice daily for 28 consecutive days, in a 4-week (28 days) cycle, in patients with locally advanced or metastatic basal cell carcinoma (BCC). The safety and tolerability of CX-4945, preliminary evidence of antitumor effect, and the effect of CX-4945 treatment on the Hh signaling pathway will also be evaluated in this study.

Primary Outcome

Determination of RP2D for the expansion cohorts

Interventions

  • DRUG CX-4945

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2019-04-16
Est. Completion 2024-01-25
Phase Phase 1
Senhwa Biosciences

4 total trials

What the finished NCT03897036 record still lists

NCT03897036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 1 intervention - of which CX-4945 is the first listed.

NCT03897036 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03897036 about?

NCT03897036 is a clinical study titled "Treatment Duration Increment and Pharmacodynamic Study of CX-4945 in Patients With Basal Cell Carcinoma (BCC)". This study is to determine the recommended phase II dose (RP2D) and schedule of CX-4945 when administered orally twice daily for 28 consecutive days, in a 4-week (28 days) cycle, in patients with locally advanced or metastatic basal cell carcinoma (BCC). The safety and tolerability of CX-4945, preli...

What is the current status of trial NCT03897036?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2019-04-16. Estimated completion is 2024-01-25.

What interventions are being tested in trial NCT03897036?

The interventions under investigation include: CX-4945 (DRUG).

Who is sponsoring clinical trial NCT03897036?

This trial is sponsored by Senhwa Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03897036's enrollment target sits among peer trials

25 1495th of 2000 higher than 481 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 NCT03897036, the US trial registry maintained by the National Library of Medicine. NCT03897036 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.