Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Dermatologic Agents

All Drugs and Chemicals

Anti-Infective Agents

Gastrointestinal Agents

Antineoplastic Agents

Sunscreening Agents

Doxycycline

Erythromycin

Erythromycin Estolate

Erythromycin Ethylsuccinate

Erythromycin stearate

Panitumumab

Anti-Bacterial Agents

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Enzyme Inhibitors

Experimental Arm (ARM A) skin- treatment: erythromycin cream 2% daily at bedtime doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2 skin moisturizer daily at morning, sunscreen before going outdoors for 8 weeks

Standard Arm (ARM B) skin- treatment:doxycycline 100mg b.i.d. skin moisturizer daily at morning, sunscreen before going outdoors for 8 weeks

Comparison of efficacy of Arm A erythromycin cream 2% daily at bedtime (doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2) and Arm B doxycycline 100mg b.i.d. in patients with Metastatic Colorectal cancer (Ras wild-type)being treated with panitumumab.

Melanie Kripp, Dr. med.

80 - 90 % of the patients treated with anti-EGFR antibodies (panitumumab or cetuximab) experience skin toxicity, mostly acne like skin rash.

A standardized treatment of skin rash is neither established as standard arm for clinical trials nor as guideline for the treatment of skin toxicity in clinical practice. While an improvement of QoL has been demonstrated for panitumumab and cetuximab in comparison to best supportive care the data basis for patient related outcomes regarding skin toxicity deriving from randomized trials is still small.

Recent surveys among German oncologist revealed that physicians are reluctant to use oral antibiotics as preemptive treatment . Only 19 out of 110 oncologists stated that they are thinking about using preemptive treatment in patients with acne-like skin rash.

Thus, in the present trial two main questions will be addressed:

(i) Can preemptive treatment with oral doxycycline be replaced by a sequential skin treatment strategy (i.e. local treatment with erythromycin followed by doxycycline in case of inefficacy = development of acne) without compromising treatment efficacy of skin toxicity treatment? (ii) Comparison of general and skin related QoL between both treatment arms.

Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of QoL in Patient With Ras-wt Colorectal Cancer

Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of Quality of Life in Patients With Ras-wildtype Colorectal Cancer

Percentage of patients developing no skin toxicity ≥ grade 2 at any time during their first 8-weeks of treatment with panitumumab.

Quality of life will be assessed by standardized skin-related (DLQI) and global quality of life (EORTC QLQ C30.

For correlation analyses between the different quality of life scores, the non-parametric test according to Spearman will preferably be applied.

Assess different skin toxicity grading scales (i.e. NCI CTC v. 4.0; WoMo score; MESTT)

Description of correlation between skin-related and global quality of life using EORTC-QLQ C30 and SF-36.

Describe the development of late skin toxicity after 8 weeks

Rate of skin-toxicity induced dose reductions (including withdrawal) of panitumumab

AIO-Studien-gGmbH

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Lymphoma

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Waldenstrom Macroglobulinemia

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Follicular Lymphoma

Marginal Zone Lymphoma

Amino Acids

Voriconazole

Ibrutinib

Cytochrome P-450 CYP3A Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Clotrimazole

Miconazole

Antifungal Agents

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Tyrosine

Participants will receive oral treatment in six, 28-days cycles. In Cycle 1, participants will take ibrutinib 560 milligram (mg) (4\*140 mg capsules) once daily (QD) from Days 1- 4; on Days 5-11 ibrutinib 140 mg capsule QD in combination with erythromycin 500 mg tablet 3 times daily (TID); on Days 12-13 ibrutinib 140 mg capsule QD; on Days 14-18 ibrutinib 560 mg (4\*140 mg capsules) QD; on Days 19-25 ibrutinib 140 mg capsule QD in combination with voriconazole 200 mg tablet twice daily (BD); on Days 26-27 ibrutinib 140 mg capsule orally QD; and on Day 28 and in subsequent treatment Cycles (2-6) participants will continue oral treatment with ibrutinib 420 mg or 560 mg QD (depending on the subtype of B-cell malignancy).

Participants will receive oral treatment in six, 28-days cycles. In Cycle 1, participants will take ibrutinib 560 mg (4\*140 mg capsules) QD from Days 1- 4; on Days 5-18 ibrutinib 560 mg (4\*140 mg capsules) QD in combination with either erythromycin 500 mg tablet TID (Group 1) or voriconazole 200 mg tablet BD (Group 2); on Day 19 and in subsequent treatment Cycles (2-6) participants will continue oral treatment with ibrutinib 420 mg or 560 mg QD (depending on the subtype of B-cell malignancy).

Ibrutinib capsule (at dose level of 140 or 420 or 560 mg) will be taken orally QD up to six, 28-days cycles.

Erythromycin 500 mg tablet will be taken orally TID (Part1 Cycle 1: on Days 5-10 and morning dose on Day 11; Part2 Cycle 1: on Days 5-17 and morning dose on Day 18).

Voriconazole 200 mg tablet will be taken orally BD (Part1 Cycle 1: on Days 19-25; Part2 Cycle 1: on Days 5-17).

Janssen Research & Development, LLC Clinical Trials

The purpose of this study is to assess the effect of a moderate Cytochrome P450 (CYP) 3A inhibitor (erythromycin) and a strong CYP3A inhibitor (voriconazole) on the steady-state pharmacokinetics (PK \[the study of the way a drug enters and leaves the blood and tissues over time\]) of repeated oral doses of ibrutinib in participants with B-cell malignancy (cancer or other progressively enlarging and spreading tumors).

This is an open-label (participants and researchers are aware about the treatment participants are receiving), multi-center (when more than 1 hospital or medical school team work on a medical research study), drug-drug interaction (DDI) study of ibrutinib with the moderate and the strong CYP3A inhibitors (erythromycin and voriconazole respectively) in participants with B-cell malignancies (including Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma \[CLL/SLL\], Follicular Lymphoma \[FL\], Marginal Zone Lymphoma \[MZL\], Waldenstrom's Macroglobulinemia \[WM\] or Mantle Cell Lymphoma \[MCL\]). The study will consist of a Screening Phase (28 days), a Treatment Phase (consisting of six 28-days cycles), and an End-of-Treatment (EoT) Visit (within 30 days after the last dose of study drug). The study will consist of 2 Parts. In Part 1, extent of the DDI between ibrutinib at dose level of 140 milligram (mg) and CYP3A inhibitors will be assessed. After completion of Part 1 of the study, an interim analysis of all available PK and safety data will be conducted and Part 2 will only be performed if the observed drug interaction is less than anticipated based on current information. In Part 2, safety and PK of ibrutinib at dose level of 560 mg administered with CYP3A inhibitors will be assessed. Participants who continue to derive clinical benefit from ibrutinib treatment at the end of this study, and who are eligible to continue in the PCI-32765CAN3001 study (NCT01804686) will end their participation in this trial, have an EoT visit completed, and will continue receiving ibrutinib as a part of the PCI-32765CAN3001 protocol. Participants' safety will be monitored throughout the study.

Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy

A Drug-drug Interaction Study of Ibrutinib With Moderate and Strong CYP3A Inhibitors in Patients With B-cell Malignancy

The Cmax is the maximum observed plasma concentration.

The Cmin is the minimum observed plasma concentration.

The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.

Ratio of ibrutinib metabolite concentration to parent compound (ibrutinib) concentration will be assessed.

The AUC (t1 and t2) is the partial area under the plasma concentration-time curve from time 't1' to 't2' hours.

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

Janssen Research & Development, LLC

Polyps

Pharmaceutical Solutions

Antiemetics

Cardiotonic Agents

Herbal and Botanical

Metoclopramide

Bisacodyl

Sennosides

Dopamine

Dopamine Antagonists

Dopamine Agents

Neurotransmitter Agents

Laxatives

Cathartics

Cola

Senna

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-CONTROL

Senna tablets

SUPREP oral sulfate solution

SUPREP oral sulfate solution with Gastrografin

Douglas K Rex, Dr.

This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON 2 Capsule Endoscopy System (CCE) procedures in average risk patients.

Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam CCE.

This is a multicenter, prospective, consecutive, randomized study. Average-risk subjects undergoing CCE without optical colonoscopy will be consecutively enrolled and randomized 1:1 to receive one of two bowel preparation regimens prior to PillCam CCE.

Subjects will be enrolled at 5-10 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit and will be evaluated on the procedure day or until capsule excretion. A telephone follow-up will be conducted 5 to 9 days post-capsule ingestion to verify capsule excretion, assess patient well-being, and capture any adverse events.

Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure

COVGIC20482: A Multicenter, Consecutive, Randomized Study to Optimize the Bowel Preparation Regimen for the PillCam COLON 2 Capsule Endoscopy Procedure

The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).

Will be assessed from RAPID video in total and by segment

Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment

Will be assesses by applicable case report form (CRF)

Medtronic - MITG

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Control

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Bowel Preparation Regimen -Control

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

Bowel Preparation Regimen-Test

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-CONTROL

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Liron Bar Yaakov

Overall Excellent cleansing

Cecum Excellent cleansing

Ascending Excellent cleansing

Transverse Excellent cleansing

Descending Excellent cleansing

Rectum Excellent cleansing

Overall Good cleansing

Cecum Good cleansing

Ascending Good cleansing

Transverse Good cleansing

Descending Good cleansing

Rectum Good cleansing

Overall Fair cleansing

Cecum Fair cleansing

Ascending Fair cleansing

Transverse Fair cleansing

Descending Fair cleansing

Rectum Fair cleansing

Overall Poor cleansing

Cecum Poor cleansing

Ascending Poor cleansing

Transverse Poor cleansing

Descending Poor cleansing

Rectum Poor cleansing

this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon.

Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)

Overall (any size)

Cecum (any size)

Ascending (any size)

Transverse (any size)

Descending (any size)

rectum (any size)

Overall (polyps ≥6mm)

Cecum (polyps ≥6mm)

Ascending (polyps ≥6mm)

Transverse (polyps ≥6mm)

Descending (polyps ≥6mm)

Rectum (polyps ≥6mm)

Overall (polyps ≥10mm)

Cecum Overall (polyps ≥10mm)

Ascending Overall (polyps ≥10mm)

Transverse (polyps ≥10mm)

Descending (polyps ≥10mm)

Rectum (polyps ≥10mm)

This analysis is a subset of the PPAs excluding patients with one or more missing video data for Cecum, Ascending and transverse colon. Patients with at least one polyp detected on overall segments.

Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE

Bowel Preparation Regimen - Control

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure- Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

The following patients were excluded from the analysis:2 withdrawn patients, 1 LTF (Lost to follow-up) patient, 2 pattients with failed prcedure, 16 patients with incomplete COLON exam.

Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure- Control

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE

PPAS: Subjects withdrawn prior to the PillCam procedure (3) and subjects with one or more of the following protocol deviations (13) have been excluded: Evening PEG intake \<1h and \> 2.15h, Morning PEG intake \<1h and \>2:15 h, Capsule ingestion l\<45 min or \>75 min after PEG intake , Overall PEG intake volume is less than 3 liters

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of QoL in Patient With Ras-wt Colorectal Cancer	NCT01668498	Ras-wildtype Co...	Erythromycin Doxycycline	18 Years -	AIO-Studien-gGmbH
Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy	NCT02381080	B-Cell Chronic ...	Ibrutinib Erythromycin Voriconazole	18 Years -	Janssen Research & Development, LLC
Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure	NCT02481219	Colorectal Canc...	PillCam® COLON ... Senna tablets PEG Metoclopramide Erythromycin SUPREP oral sul... Bisacodyl SUPREP oral sul...	50 Years - 75 Years	Medtronic - MITG
Erythromycin Treatment for Readthrough of APC Gene Stop Codon Mutation in Familial Adenomatous Polyposis-minors' Adjusted Version	NCT02354560	FAP-Familial Ad...	Erythromycin	10 Years - 17 Years	Tel-Aviv Sourasky Medical Center
Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy	NCT02381080	B-Cell Chronic ...	Ibrutinib Erythromycin Voriconazole	18 Years -	Janssen Research & Development, LLC

Spots Global Cancer Trial Database for erythromycin

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