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NCT03997448 · ClinicalTrials.gov registry record · Phase 2

Abemaciclib and Pembrolizumab in Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma: Big Ten Cancer Research Consortium BTCRC-GI18-149

A Phase 2 study, sponsored by Nataliya Uboha.

Terminated
Registry status
Phase 2
Development phase
3
Enrollment target

NCT03997448: Clinical Trial Phase 2 study, sponsored by Nataliya Uboha.

NCT03997448 is a Phase 2 study that was terminated before completion, run by Nataliya Uboha. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03997448, a Phase 2 study, was terminated before completion, sponsored by Nataliya Uboha.

TERMINATED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

This study will test the combination of abemaciclib with pembrolizumab in patients with gastric, gastroesophageal junction, or esophageal adenocarcinoma that is metastatic or cannot be surgically removed, and who have progressed on, or were unable to tolerate, at least 2 earlier courses of treatment for their advanced disease.

Primary Outcome

Progression free survival is defined as the time of treatment initiation until the criteria for disease progression per RECIST1.1 are met or until the date of a death event (any cause). Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase o

Interventions

  • DRUG Pembrolizumab
  • DRUG Abemaciclib

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2019-08-26
Est. Completion 2020-01-30
Phase Phase 2
Nataliya Uboha

2 total trials

Why NCT03997448 stopped before completion

NCT03997448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

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

NCT03997448 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03997448 about?

NCT03997448 is a clinical study titled "Abemaciclib and Pembrolizumab in Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma: Big Ten Cancer Research Consortium BTCRC-GI18-149". This study will test the combination of abemaciclib with pembrolizumab in patients with gastric, gastroesophageal junction, or esophageal adenocarcinoma that is metastatic or cannot be surgically removed, and who have progressed on, or were unable to tolerate, at least 2 earlier courses of treatment...

What is the current status of trial NCT03997448?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2019-08-26. Estimated completion is 2020-01-30.

What interventions are being tested in trial NCT03997448?

The interventions under investigation include: Pembrolizumab (DRUG), Abemaciclib (DRUG).

Who is sponsoring clinical trial NCT03997448?

This trial is sponsored by Nataliya Uboha, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03997448's enrollment target sits among peer trials

3 2001st of 2000 the lowest 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 NCT03997448, the US trial registry maintained by the National Library of Medicine. NCT03997448 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.