Erlotinib Hydrochloride and Quinacrine Dihydrochloride in Stage IIIB-IV Non-Small Cell Lung Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

Conditions
Recurrent Non-small Cell Lung CancerStage IIIB Non-small Cell Lung CancerStage IV Non-small Cell Lung Cancer
Interventions
DRUG

erlotinib hydrochloride

"Dose Escalation Group:~Begins day 1: given 150mg daily, orally~Extension Group:~Begins Day 1: 150mg daily, orally"

DRUG

quinacrine dihydrochloride - Escalation dose

Begins Day 8: Loading dose (first cycle only) 50mg three times daily for 7 days followed by 21 days of 50mg maintenance dose. Level -1: Loading dose (50mg three times daily for 7 days), maintenance dose (50mg every other day for three weeks). Level 1 \[starting dose\]: Loading dose (50mg three times daily for 7 days), maintenance dose (50mg daily for three weeks). Level 2: Loading dose (100mg three times daily for 7 days), maintenance dose (100mg every other day for three weeks). Level 3: Loading dose (150mg three times daily for 7 days), maintenance dose (200mg every other day for three weeks). Level 4: Loading dose (200mg three times daily for 7 days), maintenance dose (400mg every other day for three weeks). Subsequent patient cohort(s) will be enrolled depending on the safety and tolerability of subjects

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

pharmacological study

Correlative studies

DRUG

quinacrine dihydrochloride - Extension dose

Participants will be treated at recommended dose from expansion group to confirm tolerability and evaluate early response

Trial Locations (1)

44106

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer, Cleveland

All Listed Sponsors
lead

Neelesh Sharma MD PhD

OTHER

NCT01839955 - Erlotinib Hydrochloride and Quinacrine Dihydrochloride in Stage IIIB-IV Non-Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter