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NCT02116530 · ClinicalTrials.gov registry record · Phase 3

Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy

A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 3
Development phase
401
Enrollment target

NCT02116530: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.

NCT02116530 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 401 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02116530, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 3
Development phase
401 participants
Enrollment target

Study Summary

This randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by blocking brain receptors that appear to be involved in nausea and vomiting.

Primary Outcome

No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy.

Interventions

  • OTHER Placebo
  • DRUG Olanzapine
  • DRUG Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)
  • DRUG Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)

Trial Details

FieldValue
Enrollment Target 401 participants
Start Date 2014-08-20
Est. Completion 2017-06-15
Phase Phase 3

What the finished NCT02116530 record still lists

NCT02116530 is an interventional study that assigns participants to a tested intervention. The registered 401 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT02116530 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02116530 about?

NCT02116530 is a clinical study titled "Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy". This randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Antiemetic drugs, such ...

What is the current status of trial NCT02116530?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 401 participants. The study started on 2014-08-20. Estimated completion is 2017-06-15.

What interventions are being tested in trial NCT02116530?

The interventions under investigation include: Placebo (OTHER), Olanzapine (DRUG), Chemotherapy (cisplatin or cyclophosphamide and doxorubicin) (DRUG), Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant) (DRUG).

Who is sponsoring clinical trial NCT02116530?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02116530's enrollment target sits among peer trials

401 921st of 2000 higher than 1,079 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT02116530, the US trial registry maintained by the National Library of Medicine. NCT02116530 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.