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NCT01987232 · ClinicalTrials.gov registry record · Phase 1

Phase 1b/2 Study of Carfilzomib, Carboplatin, and Etoposide in Patients With Previously Untreated Extensive Stage Small-cell Lung Cancer

A Phase 1 study, sponsored by Amgen.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT01987232: Completed Phase 1 study, sponsored by Amgen.

NCT01987232 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01987232, a Phase 1 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

The purpose of this study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of carfilzomib given in combination with carboplatin and etoposide as initial therapy for patients with extensive-stage small-cell lung cancer (ES SCLC).

Primary Outcome

The maximum tolerated dose (MTD) was defined as the highest dose level at which \< 33% of participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle. Dose-limiting toxicities were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. A DLT was defined as: * A grade 3 or greater non-hematologic toxicity that was assessed as related to carfilzomib by the investigator except in the case of neuropathy

Interventions

  • DRUG Carboplatin
  • DRUG Etoposide
  • DRUG Carfilzomib

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2013-11-05
Est. Completion 2017-05-04
Phase Phase 1
Amgen

558 total trials

What the finished NCT01987232 record still lists

NCT01987232 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.

NCT01987232 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01987232 about?

NCT01987232 is a clinical study titled "Phase 1b/2 Study of Carfilzomib, Carboplatin, and Etoposide in Patients With Previously Untreated Extensive Stage Small-cell Lung Cancer". The purpose of this study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of carfilzomib given in combination with carboplatin and etoposide as initial therapy for patients with extensive-stage small-cell lung cancer (ES SCLC).

What is the current status of trial NCT01987232?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2013-11-05. Estimated completion is 2017-05-04.

What interventions are being tested in trial NCT01987232?

The interventions under investigation include: Carboplatin (DRUG), Etoposide (DRUG), Carfilzomib (DRUG).

Who is sponsoring clinical trial NCT01987232?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01987232's enrollment target sits among peer trials

32 1296th of 2000 higher than 679 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 NCT01987232, the US trial registry maintained by the National Library of Medicine. NCT01987232 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.