Table 2.

Clinical study reports of the action of P-gp on cancer cells.

Responsible Party	Phase	Condition or Disease	Treatment or Intervention	Number of Participants	Age and Sex	Outcome Measures	Study Start Date	Identification Number
Astellas Pharma Inc.	Phase 1	Prostate cancer	Enzalutamide, enzalutamide placebo, digoxin, rosuvastatin	24	18 years (Y) and older males	Pharmacokinetics and adverse effects	27 January 2020	NCT04094519
National Institute of Diabetes and Digestive and Kidney Diseases	Phase 2	Thyroid cancer	Procedure: skin biopsy	20	All	Thyroid hormone effect on P-gp activity in thyroid patients	April 2004	NCT00080574
National Institutes of Health (NIH) Clinical Center (CC)	Phase 2	Adrenal cortex neoplasm	Drug: XR9576 (tariquidar)	50	18 Y and older, all gender	Effect of P-gp antagonist before and after surgery.	October 2003	NCT00071058
Janssen-Cilag International NV	Phase 1	Healthy	Pimodivir, cyclosporine	18 participants	18 Y to 55 Y, all gender	Examine the pharmacokinetics of pimodivir in healthy adults using cyclosporine, a P-gp, BCRP, and organic-anion-transporting polypeptide Inhibitor.	6 December 2018	NCT03768609
National Cancer Institute (NCI)	Phase 2	Lung cancer, ovarian cancer cervix cancer, renal cancer	Docetaxel, tariquidar, 99mTc-sestamibi imaging	48 participants	18 Y and older, all gender	Tariquidar (XR9576), a P-gp antagonist, in combination with docetaxel in patients with ovarian, lung, renal, or cervical cancer: a study of the tariquidar-docetaxel interaction	September 2003	NCT00069160
Janssen Research & Development, LLC	Phase 1	Alzheimer disease	Drug: 11C-JNJ-63779586	11 participants	18 Y to 85 Y, all gender	P-gp and BCRP substrates, as well as the positron emission tomography ligand 11C-JNJ-63779586, were used in an open-label microdosing study in the human brain to investigate the regional brain kinetics of brain drug transporters.	17 May 2017	NCT03089918
NIH CC	Phase 1	BC, lung cancer, ovarian cancer	Vinorelbine, XR9576	30 participants	All age groups and gender	A clinical trial of the P-gp antagonist, XR9576, in combination with vinorelbine in patients with cancer: analysis of the interaction between XR9576 and vinorelbine	December 1999	NCT00001944
NIH CC	Phase 1	BC, kidney cancer, lymphoma cancer, metastasis ovarian cancer.	Drug: PSC 833	80 participants	All age groups and gender	A phase I study of P-gp antagonist PSC 833 infusional chemotherapy	September 1992	NCT00001302
NIH CC	Phase 1	Wilms’ tumour, sarcoma adenaocortical carcinoma, refractory cancer, coldrhood cancer	Tariquidar	29 participants	2 Y to 18 Y, all gender.	Tariquidar (XR9576), a P-gp inhibitor, was studied in a phase I trial and pharmacokinetic study in paediatric patients with refractory solid tumours, including brain tumours, in combination with doxorubicin, vinorelbine, or docetaxel.	February 15, 2001	NCT00011414
NIH CC	Phase 1	BC, carcinoma, renal cell lymphoma, ovarian cancer	PSC 833, paclitaxel	52 participants	All ages and all gender groups included	Paclitaxel infusion with the P-gp antagonist PSC 833 in a phase I study	March 1994	NCT00001383
Susan Bates, National Cancer Institute (NCI)	Not applicable	Cervical, ovarian, lung, breast, and renal cancer	Paclitaxel, CBT-1(Registered trademark), radiation: Tc 99m sestamibi	12 participants	18 Y to 80 Y, all sex eligible for the study	A pharmacodynamic study of CBT-1, a P-gp (Pgp) antagonist, evaluating Pgp inhibition in tumours and normal tissues	December 2007	NCT00972205
NIH CC	Phase 1	Kidney cancer and metastasis	PSC 833, vinblastine	46 participants	All ages and sex are eligible for the study.	Continuous intravenous PSC 833 and vinblastine infusion in patients with metastatic renal cancer: A phase I study	February 1997	NCT00001570
Francisco Robert, MD, the University of Alabama at Birmingham	Phase 2	Non-small cell lung cancer (NSCLC) stage IV NSCLC metastatic NSCLC	Cabazitaxel-XRP6258 (3-week cycle), cabazitaxel-XRP6258 (5-week cycle)	28 participants	19 Y and older and all sexes eligible for the study	A Phase II trial of a novel taxane (cabazitaxel-XRP6258) in patients with previously treated advanced non-small-cell lung cancer (NSCLC).	September 2011	NCT01438307
Merck KGaA, Darmstadt, Germany	Phase 1	Healthy	Dabigatran etexilate, tepotinib	20 participants	18 Y to 44 Y, all sexes are eligible for this study	The purpose of this Phase I, open-label, single-sequence, two-period study is to assess the effect of tepotinib on P-gp by investigating the pharmacokinetics of the P-gp probe substrate dabigatran etexilate in healthy subjects.	17 May 2018	NCT03492437
NIH CC		Low-grade glioma, glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, oligoastrocytoma		2 participants	18 Y to 99 Y, all sexes eligible for the study	(11C)N-desmethyl-loperamide as a P-gp function marker in glioma patients	13 January 2011	NCT01281982
Christopher H. Lowrey, Dartmouth-Hitchcock Medical Center	Phase 1	Leukaemia	Biological: sargramostim, Drug: mitomycin C, Drug: mitoxantrone hydrochloride	29 participants	18 Y to 120 Y, all sexes are eligible for this study.	A phase I evaluation of mitomycin C and mitoxantrone in patients with acute myelogenous leukaemia and a pilot clinical trial of mitomycin C modulation of MDR protein	September 1996	NCT00003003
Grupo Espanol de Investigacion en Sarcomas		Osteosarcoma		115 participants	12 Y to 30 Y, all sexes eligible for the study	P-gp expression as a biomarker for non-metastatic osteosarcoma of the extremities: a prospective observational study	2 July 2014	NCT04383288
Italian Sarcoma Group	Phase 2	Osteosarcoma	Mifamurtide arm, other: 3 drugs arm	225 participants	Up to 40 Y, all sexes are eligible	ABCB1/P-gp expression as a biologic stratification factor in patients with nonmetastatic osteosarcoma (ISG/OS-2)	23 June 2011	NCT01459484