A Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors (TKI) for EGFR -Mutant Advanced NSCLC

Sponsor
Lady Davis Institute
Study ID
NCT02321293
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CurcuVIVA™ — DIETARY_SUPPLEMENT
    80 mg PO daily for 8 weeks with an option to reduce the dose based on individual tolerability
  • Tyrosine Kinase Inhibitor gefitinib (Iressa) — DRUG
    250 mg PO daily until progression
  • Tyrosine Kinase Inhibitor erlotinib (Tarceva) — DRUG
    150 mg PO daily until progression

Study Details

The purpose of this study is is to assess the safety and tolerability of curcumin in combination with EGFR-TKIs in selected patients with advanced non-resectable mutant EGFR NSCLC.

Key Dates

First listed
Dec 22, 2014
Start date
Aug 31, 2015
Status verified
Sep 2015
Primary completion
Aug 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP

Arms

  • Experimental: 1
    CurcuVIVA™ (NPN 80027414) at a single dose of 80 mg PO daily without any dose escalation to be taken in conjunction with an EGFR-TKI therapy. CurcuVIVA™ is given in capsule forms. Unit strength of CurcuVIVA™ is equal to Turmeric Extract 25:1 348 mg (containing 80mg Longvida® Optimized Curcumin) Tyrosine Kinase Inhibitors: 1. Gefitinib is a targeted therapy, given in a capsule form once daily. The daily dose is 250 mg . 2. Erlotinib is a targeted therapy, given in a capsule form once daily. The daily dose is 150 mg . Study intervention is 8 weeks, following which the patients will continue taking their EGFR-TKI without curcumin until progression. The side effects of curcumin will be followed for another 8 weeks from the date of stopping curcumin.

Primary Outcome Measure

feasibility assessed by: Willingness of patients to participate= Number of enrolled/Number of approached patients, [ Time Frame: 8 weeks ]

Central Contacts

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