Neoplasms Clinical Trial
Official title:
A Phase I Dose Escalation Study of MK1496 in Patients With Advanced Solid Tumor
This study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed standard therapy or for whom no standard therapy exists, in two dosing schedules in Japan.
Status | Completed |
Enrollment | 27 |
Est. completion date | January 2011 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria - Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. - Participant must have Performance Status 0 or 1. - Participant must have adequate organ function. Exclusion Criteria - Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration. - Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen). - Participant has known hypersensitivity to the components of study drug or its analogs. - Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Dose-limiting Toxicities (DLTs) | Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product. | Cycle 1 (up to 21 or 28 days, depending on treatment arm) | Yes |
Primary | Number of Participants With Any Clinical or Laboratory Adverse Event | This is a measure of the number of participants who experienced any adverse event (AE) while on study. | First dose up to 30 days after last dose (up to 2 years) | Yes |
Secondary | Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle) | AUC[0-24] is a measure of the total plasma exposure of drug over a 24-hour period after the initial dose; for this analysis AUC was measured on Day 1 of the first 21-day cycle. AUC[0-24] for the 28-day cycle is reported as Outcome Measures 4 and 5. |
Cycle 1, Day 1 (Hour 0 through Hour 24) | No |
Secondary | Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle) | AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 1 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements. AUC[0-24] for the Day 3 doses is reported as Outcome Measure 5. |
Cycle 1, Day 1 (Hour 0 through Hour 24) | No |
Secondary | Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle) | AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 3 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements. AUC[0-24] for the Day 1 doses is reported as Outcome Measure 4. |
Cycle 1, Day 3 (Hour 0 through Hour 24) | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03826043 -
THrombo-Embolic Event in Onco-hematology
|
N/A | |
Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
Completed |
NCT01938846 -
BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06058312 -
Individual Food Preferences for the Mediterranean Diet in Cancer Patients
|
N/A | |
Completed |
NCT03308942 -
Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants
|
Phase 2 | |
Recruiting |
NCT06018311 -
Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads
|
N/A | |
Withdrawn |
NCT05431439 -
Omics of Cancer: OncoGenomics
|
||
Completed |
NCT01343043 -
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma
|
Phase 1 | |
Completed |
NCT01938638 -
Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer
|
Phase 1 | |
Recruiting |
NCT05514444 -
Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)
|
Phase 1 | |
Recruiting |
NCT02292641 -
Beyond TME Origins
|
N/A | |
Terminated |
NCT00954512 -
Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04958239 -
A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors)
|
Phase 1 | |
Recruiting |
NCT04627376 -
Multimodal Program for Cancer Related Cachexia Prevention
|
N/A | |
Completed |
NCT01222728 -
Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
|
||
Recruiting |
NCT06004440 -
Real World Registry for Use of the Ion Endoluminal System
|
||
Active, not recruiting |
NCT05636696 -
COMPANION: A Couple Intervention Targeting Cancer-related Fatigue
|
N/A | |
Not yet recruiting |
NCT06035549 -
Resilience in East Asian Immigrants for Advance Care Planning Discussions
|
N/A | |
Recruiting |
NCT06004466 -
Noninvasive Internal Jugular Venous Oximetry
|
||
Completed |
NCT02909348 -
Immunophenotyping of Melanoma Patients on Treatment With Pembrolizumab
|