Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01703481 | A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493 in Adult Participants With Advanced or Refractory Solid Tumors or Lymphoma | PHASE1 | COMPLETED | 188 | — | — | Jun 15, 2012 | Jul 5, 2017 | Feb 3, 2025 | 37 | United States, France +1 |
The maximum tolerated dose as determined in Part 1 of the study will be used as the recommended dose for Part 2, 3 and Part 4.
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | Dose Escalation, Part 1: Participants will be enrolled in sequential cohorts to determine recommended Phase 2 doses (RP2D). |
| Part 2 | EXPERIMENTAL | Dose Confirmation, Part 2: Tumor biopsy cohorts will confirm RP2D. |
| Part 3, Cohort A | EXPERIMENTAL | First dose expansion, Part 3: Participants with squamous non-small cell lung cancer. |
| Part 3, Cohort B | EXPERIMENTAL | First dose expansion, Part 3: Participants with small cell lung cancer. |
| Part 3, Cohort C | EXPERIMENTAL | First dose expansion, Part 3: Participants with breast cancer. |
| Part 3, Cohort D | EXPERIMENTAL | First dose expansion, Part 3: Participants with solid tumors (consisting of one of the following: gastric, head and neck, lung adenocarcinoma, urothelial, glioblastoma multiforme \[GBM\], ovarian or prostate). |
| Part 4, Cohort E | EXPERIMENTAL | Second dose expansion, Part 4: Participants with non-small cell lung cancer. |
| Part 4, Cohort F | EXPERIMENTAL | Second dose expansion, Part 4: Participants with solid tumors (consisting of one of the following: breast, urothelial, GBM). |
| Name | Type | Description |
|---|---|---|
| JNJ-42756493: Part 1 | DRUG | 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). |
| JNJ-42756493: Part 2 | DRUG | 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). |
| JNJ-42756493: Part 3 | DRUG | Participants will receive JNJ-42756493 at first RP2D of 9 mg daily in Part 3 orally once daily on a 21 days cycle. |
| JNJ-42756493: Part 4 | DRUG | 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. |
Inclusion Criteria: * Histologically or cytologically confirmed: solid malignancy or lymphoma that is metastatic or unresectable, and for which standard curative treatment is no longer effective (Part 1); any type of advanced or refractory solid malignancy (excluding lymphoma) that is metastatic or...