NCT01606748

An Open-Label, Non-controlled, Non-randomized Sequential Design, Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin in Patients With Advanced Solid Cancers

Completed Phase 2 Results posted Last updated 10 September 2019

What this trial tests

Phase 2 trial testing Necitumumab in Malignant Solid Tumor in 35 participants. Completed in 1 June 2016.

Timeline

1 August 2012

Primary endpoint
1 June 2013

1 June 2016

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	1 August 2012
Primary completion	1 June 2013
Estimated completion	1 June 2016
Sites	4 locations across United States

Drugs / interventions tested

• Necitumumab (NECITUMUMAB) — full drug profile →
• Gemcitabine (gemcitabine) — full drug profile →
• Cisplatin (cisplatin) — full drug profile →

Conditions studied

• Malignant Solid Tumor — all drugs for Malignant Solid Tumor →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Malignant Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab
  Time frame: Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 Hour (h) Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion
• PK: Dose-Normalized Cmax of Gemcitabine
  Time frame: Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion
• PK: Dose-Normalized Cmax of Cisplatin
  Time frame: Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion
• PK: Area Under Concentration-Time Curve From Zero to Time 168 (AUC[-168]) of Necitumumab
  Time frame: Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion
• PK: Dose-Normalized AUC(0-24) of Gemcitabine
  Time frame: Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion
• PK: Dose-Normalized AUC(0-5) of Cisplatin
  Time frame: Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion

Sponsor's own description

The purpose of this study is to investigate the pharmacokinetics (PK) of necitumumab in combination with gemcitabine-cisplatin in participants with advanced malignant solid tumors and to assess the potential for drug-drug interactions between necitumumab and gemcitabine-cisplatin.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Metabolism, Biochemical Actions, and Chemical Synthesis of Anticancer Nucleosides, Nucleotides, and Base Analogs.
   Shelton J, Lu X, Hollenbaugh JA, Cho JH, et al · · 2016 · cited 219× · PMID 27960273 · DOI 10.1021/acs.chemrev.6b00209
2. Trial watch: Monoclonal antibodies in cancer therapy.
   Vacchelli E, Eggermont A, Galon J, Sautès-Fridman C, et al · · 2013 · cited 80× · PMID 23482847 · DOI 10.4161/onci.22789
3. Trial watch: Tumor-targeting monoclonal antibodies for oncological indications.
   Vacchelli E, Pol J, Bloy N, Eggermont A, et al · · 2015 · cited 32× · PMID 25949870 · DOI 10.4161/2162402x.2014.985940
4. Spotlight on necitumumab in the treatment of non-small-cell lung carcinoma.
   Thakur MK, Wozniak AJ. · · 2017 · cited 20× · PMID 28293124 · DOI 10.2147/lctt.s104207