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NCT03008278 · ClinicalTrials.gov registry record · Phase 1

Olaparib and Ramucirumab in Treating Patients With Metastatic or Locally Recurrent Gastric or Gastroesophageal Junction Cancer That Cannot Be Removed by Surgery

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
51
Enrollment target

NCT03008278: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT03008278 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03008278, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
51 participants
Enrollment target

Study Summary

This phase I/II trial studies the side effects and best dose of olaparib when given together with ramucirumab and how well they work in treating patients with gastric or gastroesophageal junction cancer that has spread to other places in the body (metastatic), has come back (recurrent), or cannot be removed by surgery (unresectable). Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and ramucirumab may work better in treating patients with gastric or gastroesophageal junction cancer compared to ramucirumab and paclitaxel (a chemotherapy drug) or ramucirumab alone.

Primary Outcome

Will be assessed by National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) for Adverse Events version 5.0. The safety profile and adverse event reporting were collected in an intent to treat analysis so data from all patients were included in the overall analysis and there was never any plan nor intent to evaluate or report the safety profile separately. These are not two different arms of the same study, the phase 1 part of this was a lead in to the phase 2.

Interventions

  • DRUG Olaparib
  • BIOLOGICAL Ramucirumab

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2018-02-06
Est. Completion 2025-08-13
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT03008278 record still lists

NCT03008278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).

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

NCT03008278 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03008278 about?

NCT03008278 is a clinical study titled "Olaparib and Ramucirumab in Treating Patients With Metastatic or Locally Recurrent Gastric or Gastroesophageal Junction Cancer That Cannot Be Removed by Surgery". This phase I/II trial studies the side effects and best dose of olaparib when given together with ramucirumab and how well they work in treating patients with gastric or gastroesophageal junction cancer that has spread to other places in the body (metastatic), has come back (recurrent), or cannot be...

What is the current status of trial NCT03008278?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2018-02-06. Estimated completion is 2025-08-13.

What interventions are being tested in trial NCT03008278?

The interventions under investigation include: Olaparib (DRUG), Ramucirumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03008278?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03008278's enrollment target sits among peer trials

51 969th of 2000 higher than 1,028 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 NCT03008278, the US trial registry maintained by the National Library of Medicine. NCT03008278 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.