A Study to Determine the Excretion Balance, Pharmacokinet... | NCT02828930

NCT02828930

ID	Type	Description	Link
RG7388	Other Identifier	Roche
2015-002532-40	EudraCT Number

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Idasanutlin	Experimental	On Day 1, 300 milligram (mg) idasanutlin tablet orally and 100 mg [14C]-radiolabeled idasanutlin capsule orally (2, 50 mg capsules containing approximately 100 microcurie of radioactivity). After 5 hours and 45 minutes of the oral dose, 100 microgram (mcg) of [13C]-radiolabeled idasanutlin will be administered over a 15-minute intravenous (IV) infusion. On Day 11, idasanutlin matching placebo aqueous dispersion orally and approximately after 1 hour, 400 mg idasanutlin tablet will be administered orally in the form of an aqueous dispersion. On Day 19, 400 mg idasanutlin tablet will be administered orally in the form of an aqueous dispersion. Participants, who are eligible to enter in optional treatment extension phase, will continue treatment with idasanutlin 200 mg tablet orally once daily for 5 days, and no treatment during 23 days of 28-day cycle, until the development of progressive disease, unacceptable toxicity, consent withdrawal or any other criteria for removal.	Drug: Idasanutlin Drug: Placebo Drug: [13C]-radiolabeled Idasanutlin Drug: [14C]-radiolabeled Idasanutlin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Idasanutlin	Drug	Idasanutlin 300 mg tablet orally on Day 1; 400 mg tablet orally on Day 11 and Day 19. Participants, who are eligible to enter in optional treatment extension phase, will continue treatment with idasanutlin 200 mg tablet orally once daily for 5 days of 28-day cycle.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Unlabeled Idasanutlin		0 Hour (hr) predose, 1, 3, 6, 7, 24, 48, 96, 120, 144, 240 hrs postdose
Maximum Observed Plasma Concentration (Cmax) of Unlabeled Idasanutlin		0 hr predose, 1, 3, 6, 7, 24, 48, 96, 120, 144, 240 hrs postdose
Area Under the Plasma Concentration Time-Curve From Time Zero to Extrapolated Infinite Time (AUC [0-inf]) of Unlabeled Idasanutlin		0 hr predose, 1, 3, 6, 7, 24, 48, 96, 120, 144, 240 hrs postdose
Area Under the Plasma Concentration Time-Curve From Zero to the Last Measured Concentration (AUC[0-last]) of Unlabeled Idasanutlin		0 hr predose, 1, 3, 6, 7, 24, 48, 96, 120, 144, 240 hrs postdose
Plasma Elimination Half-Life (t1/2) of Unlabeled Idasanutlin		0 hr predose, 1, 3, 6, 7, 24, 48, 96, 120, 144, 240 hrs postdose
Plasma Apparent Elimination Rate Constant of Unlabeled Idasanutlin		0 hr predose, 1, 3, 6, 7, 24, 48, 96, 120, 144, 240 hrs postdose
Apparent Oral Clearance (CL/F) of Unlabeled Idasanutlin		0 hr predose, 1, 3, 6, 7, 24, 48, 96, 120, 144, 240 hrs postdose
Renal Clearance (CLr) of Unlabeled Idasanutlin		0 hr predose, 1, 3, 6, 7, 24, 48, 96, 120, 144, 240 hrs postdose
Apparent Volume of Distribution (Vz/F) of Unlabeled Idasanutlin

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Baseline through 28 days after the last dose of study drug (maximum up to approximately 76 days)
Palatability Assessment Questionnaire Score for Aqueous Dispersion of Idasanutlin

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, at the discretion of the Investigator
Histologically or cytologically confirmed advanced malignancy, except leukemia and lymphoma
Measureable or evaluable disease by Response evaluation criteria in solid tumors (RECIST) version 1.1, with no more than a single active malignancy in the previous 3 to 5 years prior to the administration of study drug
Life expectancy of at least 12 weeks
Participants taking opioid analgesics for pain should be on a stable pain and palliative care bowel regimen for one month prior to the first dose of study medication
Adequate bone marrow, hepatic, and renal function
Agreement to remain abstinent or use contraceptive methods specified in the study

Exclusion Criteria:

History of any form of leukemia, except for Stage 0 - 1 chronic lymphocytic leukemia, not requiring treatment in addition to their underlying malignancy
Have received hormonal therapy within the two weeks prior to the first dose of study drug
Have pre-existing gastrointestinal disorders that may interfere with proper absorption of the drug
History of seizure disorders or unstable Central Nervous System metastases (participants with stable CNS metastases allowed)
Have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Receive certain per protocol prohibited medications while on study. These medications must be discontinued 7 days prior to start of study drug
Have bone marrow disorders, electrolyte imbalance, infrequent bowel movements (less than once per 48 hours), coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
Positive for human immunodeficiency virus currently receiving combination anti-retroviral therapy
Regular work with ionizing radiation or radioactive material or treated with radiotherapy within 3 weeks prior to the first dose of study drug
Refuse to potentially receive blood products and/or have a hypersensitivity to blood products