A Phase I, Open-Label Trial, Evaluating the Safety and Immunogenicity of Candidate Tuberculosis Vaccines AERAS-402 and MVA85A, Administered by Prime-Boost Regime in BCG-Vaccinated Healthy Adults

BACKGROUND Hand-foot skin reaction (HFSR) is a serious side effect induced by multiple-tyrosine kinase inhibitors (TKIs). HFSR can cause treatment interruption or decreased dosing. HFSR also markedly decreases quality of life and is associated with the therapeutic efficacy of multiple-TKIs. Therefore, the management and prevention of HFSR is an important issue; however, an effective method for its prevention has not been established. Specific ascorbic acid derivatives can reverse multiple-TKI-induced keratinocyte growth and pathological changes in vitro. OBJECTIVE This study was designed to evaluate the safety of bis-glyceryl ascorbate (Amitose DGA), a novel, hydrosoluble, and moisturizing ascorbic acid derivative, in patients with renal cell carcinoma (RCC) receiving sunitinib therapy. This study was also designed to evaluate Amitose DGA’s preventive efficacy for sunitinib-induced HFSR. METHODS This is a Phase I/II, single-center, uncontrolled, single-arm, open-label trial. We will recruit a total of 30 patients with RCC receiving sunitinib therapy, with a 2-week-on and 1-week-off schedule. The participants will apply Amitose DGA-containing cream over both palmar and plantar surfaces within two treatment cycles (ie, 6 weeks) of sunitinib in combination with a general moisturizing agent, in addition to standard-of-care processes. Safety assessments will include dermatological abnormalities, clinical laboratory tests, and incidence of adverse events. Efficacy assessments will include development of HFSR and therapeutic outcomes associated with sunitinib. RESULTS Recruitment to the study began in August 2017 and is ongoing in Japan. To date, 21 subjects have been recruited. Study completion is expected in 2021. CONCLUSIONS This is the first clinical study of Amitose DGA-containing cream in patients with RCC who are receiving sunitinib therapy. The single-center, single-arm, open-label design was selected to maximize subject exposure and increase the likelihood of achieving our study endpoints. The results will provide valuable and preliminary evidence of the effects of Amitose DGA-containing cream on HFSR. CLINICALTRIAL UMIN Clinical Trials Registry UMIN000027209; https://upload.umin.ac.jp/cgi-open-bin/ctr /ctr_view.cgi?recptno=R000031174 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/14636

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A phase I-II open-label trial of ispinesib on an alternate dosing schedule in chemotherapy-naive patients with locally advanced or metastatic breast cancer (MBC)

Journal of Clinical Oncology ◽

10.1200/jco.2008.26.15_suppl.1143 ◽

2008 ◽

Vol 26 (15_suppl) ◽

pp. 1143-1143 ◽

Cited By ~ 2

Author(s):

M. Philco ◽

S. Falcon ◽

H. Gomez ◽

R. Escandon ◽

K. Saikali ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Phase I ◽

Locally Advanced ◽

Metastatic Breast ◽

Open Label ◽

Dosing Schedule ◽

Open Label Trial

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MEDIOLA: A phase I/II, open-label trial of olaparib in combination with durvalumab (MEDI4736) in patients (pts) with advanced solid tumours

Annals of Oncology ◽

10.1093/annonc/mdw378.56 ◽

2016 ◽

Vol 27 ◽

pp. vi377 ◽

Cited By ~ 4

Author(s):

S. Domchek ◽

Y.-J. Bang ◽

G. Coukos ◽

K. Kobayashi ◽

N. Baker ◽

...

Keyword(s):

Phase I ◽

Solid Tumours ◽

Open Label ◽

Open Label Trial

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A Phase I, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec (T-VEC) injected into liver tumors

Journal for ImmunoTherapy of Cancer ◽

10.1186/2051-1426-3-s2-p180 ◽

2015 ◽

Vol 3 (S2) ◽

Cited By ~ 3

Author(s):

J Randolph Hecht ◽

Steven Raman ◽

Daniel Y Sze ◽

A Craig Lockhart ◽

Rebecca A Moss ◽

...

Keyword(s):

Phase I ◽

Liver Tumors ◽

Talimogene Laherparepvec ◽

Open Label ◽

Open Label Trial

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Balixafortide (a CXCR4 antagonist) plus eribulin in HER2-negative metastatic breast cancer (MBC): A Phase I open-label trial

European Journal of Cancer ◽

10.1016/s0959-8049(18)30575-6 ◽

2018 ◽

Vol 92 ◽

pp. S117-S118

Author(s):

P.A. Kaufman ◽

S. Pernas ◽

M. Martin ◽

M. Gil-Martin ◽

P. Gomez Pardo ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Phase I ◽

Metastatic Breast ◽

Cxcr4 Antagonist ◽

Open Label ◽

Open Label Trial

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Phase I, Open-Label, Single-Dose Study To Evaluate the Pharmacokinetics and Safety of Telbivudine in Children and Adolescents with Chronic Hepatitis B

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.00117-13 ◽

2013 ◽

Vol 57 (9) ◽

pp. 4128-4133 ◽

Cited By ~ 5

Author(s):

Daniel S. Stein ◽

June Ke ◽

Grace Uy ◽

Miroslava Bosheva ◽

Yin Qi ◽

...

Keyword(s):

Chronic Hepatitis ◽

Single Dose ◽

Hepatitis B ◽

Phase I ◽

Children And Adolescents ◽

Chronic Hepatitis B ◽

Healthy Adults ◽

Pharmacokinetic Data ◽

Open Label ◽

Time Profiles

ABSTRACTTelbivudine is a nucleoside analogue that has been approved for the treatment of chronic hepatitis B virus (HBV) infection in adults at 600 mg/day. We conducted a phase I, open-label, first-in-pediatrics study to investigate the safety and pharmacokinetics of a single dose of telbivudine in HBV-infected children and adolescents. Eligible patients were enrolled sequentially from older to younger groups, with evaluation of safety and available pharmacokinetic data after each stratum. Adolescent patients (>12 to 18 years) received a single dose of 600 mg telbivudine as an oral solution, while children aged 2 to 12 years received a single dose of 15 or 25 mg/kg of body weight up to a maximum of 600 mg. Telbivudine was well tolerated; all adverse events were mild, and none occurred in more than one patient. The plasma telbivudine concentration-versus-time profiles in adolescents given 600 mg were similar to the mean profile of healthy adults receiving the same oral dose. Children aged 2 to <6 and 6 to 12 years receiving a single 15-mg/kg dose showed similar plasma exposures. To predict the steady-state exposure, plasma concentration-versus-time profiles for patients aged 2 to 12 years (15 mg/kg) and >12 to 18 years (600 mg) were fitted to a two-compartment 1st-order, microconstant, lag time, 1st-order elimination pharmacokinetic (PK) model. This analysis predicted the following dosages to mimic exposures in healthy adults receiving 600 mg/day: 20 mg/kg/day for children 2 to 12 years and 600 mg/day for adolescents. Studies are ongoing to evaluate the efficacy of the recommended dose in pediatric patients. (This study has been registered at ClinicalTrials.gov under registration no. NCT00907894.)

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