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Sublingual Anvirzel in Advance Non-Small Cell Lung Cancer (NSCLC)

NCT01562301 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-06-08

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of Anvirzel (Nerium Oleander) that can be given to lung cancer patients receiving standard therapy with carboplatin and docetaxel. Researchers also want to learn what effect Nerium Oleander may have in combination with carboplatin and docetaxel.

Conditions

Interventions

DRUG

Carboplatin

AUC 6 by vein 7 days after Anvirzel administration in a 21 dayc cycle.

DRUG

Docetaxel

75 mg/m2 by vein 7 days after Anvirzel administration in a 21 day cycle.

DRUG

Anvirzel

Starting Cohort Dose: 6 mg/m2 given 3 times a day administered sublingually for a 21 day cycle. Expansion Cohort Starting Dose: Maximum tolerated dose from

BEHAVIORAL

Questionnaires

Questionnaire completion regarding physical and mental at baseline, 7 days before chemotherapy, day 1 of chemotherapy, day 1 of cycles 2, 3, and 4, and at end of dosing visit.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Nerium Biotechnology

    collaborator UNKNOWN

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Richard T. Lee, MD, FACP · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01562301 on ClinicalTrials.gov