A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493 in Adult Participants With Advanced or Refractory Solid Tumors or Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

188

Participants

Timeline

Start Date

June 15, 2012

Primary Completion Date

July 5, 2017

Study Completion Date

July 5, 2017

Conditions
Tumor or Lymphoma
Interventions
DRUG

JNJ-42756493: Part 1

Participants will receive 0.5 mg (starting dose) capsule of JNJ-42756493 orally (by mouth) once daily on Day 1 of Cycle 1. Dose of the study medication will be escalated sequentially till the dose limiting toxicity is achieved to determine the recommended part 2 doses (RP2D).

DRUG

JNJ-42756493: Part 2

Participants will receive JNJ-42756493 at the RP2D or below RP2D (maximum tolerated dose from Part 1) orally once daily on a 21 days cycle to confirm RP2D (in Part 2).

DRUG

JNJ-42756493: Part 3

Participants will receive JNJ-42756493 at first RP2D of 9 mg daily in Part 3 orally once daily on a 21 days cycle.

DRUG

JNJ-42756493: Part 4

Participants will receive JNJ-42756493 second RP2D of 10 mg intermittent dosing in Part 4 (with option to increase to 12 mg intermittent dosing based on phosphate level), orally on an intermittent schedule of daily for 7 days followed by 7 days off with a 28-day cycle.

Trial Locations (37)

Unknown

Birmingham

Tucson

La Jolla

Los Angeles

Sacramento

Santa Monica

Denver

Tampa

Augusta

Chicago

Goshen

Boston

Detroit

St Louis

New Brunswick

Albuquerque

Charlotte

Durham

Nashville

Dallas

Houston

Tyler

Fairfax

Bordeaux

Caen

Dijon

Lyon

Marseille

Saint-Herblain

Villejuif

Badalona

Barcelona

Madrid

Málaga

Pamplona

Seville

Valencia

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01703481 - A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493 in Adult Participants With Advanced or Refractory Solid Tumors or Lymphoma | Biotech Hunter | Biotech Hunter