A phase 1 dose finding study of CHR-2797, an inhibitor of M1 aminopeptidases, in patients with advanced solid tumours

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3053-3053
Author(s):  
A. Reid ◽  
A. Protheroe ◽  
G. Attard ◽  
C. Cowsill ◽  
J. Spicer ◽  
...  
Keyword(s):  
Phase 1 ◽  
Plasma Concentrations ◽  
Dose Finding ◽  
Fixed Dose ◽  
10Mg Dose ◽  
Finding Study ◽  
Orally Bioavailable ◽  
Two Phases ◽  
Ecog Ps

3053 Background: CHR-2797 is a novel, orally bioavailable inhibitor of the M1 family of aminopeptidases, in particular PuSA, and LTA4 hydrolase. Exposure of cancer cells to CHR-2797 results in the generation of the active metabolite CHR-79888 which is poorly membrane-permeable, resulting in intracellular accumulation. CHR-2797 has shown anti-proliferative activity in syngeneic (rat) and xenograft (mouse) cancer models, and is anti-angiogenic in vitro. Methods: Patients (pts) (ECOG PS ≤ 2) with histologically confirmed advanced solid tumors resistant or refractory to standard therapy were eligible. The accelerated titration design of the trial involved two phases for evaluation of schedule and dose: 1) fixed dose with increasing duration, and 2) dose escalation over a fixed duration (28 days). Results: 16 pts (median age: 64.5 years [range 48.8–80.1], 13M/3F)were treated with once daily doses ranging from 10mg to 130mg. The first four patients received a 10mg dose for 7, 14, 21 or 28 days respectively. Five subsequent cohorts received 28 days continuous dosing, with dose doubling in single patient cohorts until drug-related toxicity ≥ Grade 2. Thereafter dose was escalated in ≤ 40% increments in 3-patient cohorts. The most frequent adverse events were: gr 1–2 thrombocytopenia (44%), gr 1 diarrhea (25%), gr 1–2 transaminitis (19%), gr 1–2 fatigue (13%), gr 1 hot flushes (13%), and gr 1 lightheadedness (13%). There were no DLTs. Five patients continued therapy after 28 days; stable disease has been achieved in 1 pt for 6 months with granulosa cell carcinoma of ovary, who was progressing prior to study entry. CHR-2797 and CHR-79888 demonstrate dose proportional increases in AUC and Cmax. The terminal half-life for CHR-2797 is around 1–2 hours, whereas it is between 9 and 11 hours for CHR-79888. Intracellular (packed blood cells) exposure to both CHR-2797 and CHR-79888 is good, with CHR-79888 accumulating over 28 days, such that by day 28 the intracellular levels are comparable to plasma. Conclusions: CHR-2797 is well tolerated and can be safely administered at doses that reach plasma concentrations associated with activity in pre-clinical models. Accrual into the study continues. No significant financial relationships to disclose.

scholarly journals NCCAM/NCI Phase 1 Study of Mistletoe Extract and Gemcitabine in Patients with Advanced Solid Tumors

2013 ◽  
Vol 2013 ◽  
pp. 1-11 ◽  
Author(s):  
Patrick J. Mansky ◽  
Dawn B. Wallerstedt ◽  
Timothy S. Sannes ◽  
Jamie Stagl ◽  
Laura Lee Johnson ◽  
...  
Keyword(s):  
Clinical Response ◽  
Phase 1 ◽  
Plasma Concentrations ◽  
Stage Iv ◽  
Dosage Level ◽  
Maximum Tolerated Dose ◽  
Stage I ◽  
Fixed Dose ◽  
Mistletoe Lectin ◽  
Mistletoe Extract

Purpose.European Mistletoe (Viscum albumL.) extracts (mistletoe) are commonly used for cancer treatment in Europe. This phase I study of gemcitabine (GEM) and mistletoe in advanced solid cancers (ASC) evaluated: (1) safety, toxicity, and maximum tolerated dose (MTD), (2) absolute neutrophil count (ANC) recovery, (3) formation of mistletoe lectin antibodies (ML ab), (4) cytokine plasma concentrations, (5) clinical response, and (6) pharmacokinetics of GEM.Methods.Design: increasing mistletoe and fixed GEM dose in stage I and increasing doses of GEM with a fixed dose of mistletoe in stage II. Dose limiting toxicities (DLT) were grade (G) 3 nonhematologic and G4 hematologic events; MTD was reached with 2 DLTs in one dosage level. Response in stage IV ASC was assessed with descriptive statistics. Statistical analyses examined clinical response/survival and ANC recovery.Results.DLTs were G4 neutropenia, G4 thrombocytopenia, G4 acute renal failure, and G3 cellulitis, attributed to mistletoe. GEM 1380 mg/m2and mistletoe 250 mg combined were the MTD. Of 44 patients, 24 developed nonneutropenic fever and flu-like syndrome. GEM pharmacokinetics were unaffected by mistletoe. All patients developed ML3 IgG antibodies. ANC showed a trend to increase between baseline and cycle 2 in stage I dose escalation. 6% of patients showed partial response, 42% stable disease. Median survival was 200 days. Compliance with mistletoe injections was high.Conclusion.GEM plus mistletoe is well tolerated. No botanical/drug interactions were observed. Clinical response is similar to GEM alone.

scholarly journals Development of a Subcutaneous Fixed‐Dose Combination of Pertuzumab and Trastuzumab: Results From the Phase Ib Dose‐Finding Study

2018 ◽  
Vol 59 (5) ◽  
pp. 702-716 ◽  
Author(s):  
Whitney P. Kirschbrown ◽  
Chris Wynne ◽  
Matts Kågedal ◽  
Russ Wada ◽  
Hanbin Li ◽  
...  
Keyword(s):  
Dose Finding ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Phase Ib ◽  
Finding Study ◽  
Dose Combination ◽  
Dose Finding Study

Sa1052 IN-VITRO EVALUATION OF ANTIFOAMING EFFECTS OF SIMETHICONE: A DOSE-FINDING STUDY

2019 ◽  
Vol 89 (6) ◽  
pp. AB156 ◽  
Author(s):  
Marguerite Kutyla ◽  
Ayesha Shah ◽  
Vera Meeusen ◽  
Jerome Elson ◽  
Alex Heulsen-Katz ◽  
...  
Keyword(s):  
Dose Finding ◽  
In Vitro Evaluation ◽  
Finding Study ◽  
Dose Finding Study

scholarly journals Population Pharmacokinetic Modeling of VL-2397, a Novel Systemic Antifungal Agent: Analysis of a Single- and Multiple-Ascending-Dose Study in Healthy Subjects

2019 ◽  
Vol 63 (6) ◽  
Author(s):  
Laura L. Kovanda ◽  
Sean M. Sullivan ◽  
Larry R. Smith ◽  
Amit V. Desai ◽  
Pete L. Bonate ◽  
...  
Keyword(s):  
Antifungal Agent ◽  
Healthy Subjects ◽  
Phase 1 ◽  
Plasma Concentrations ◽  
Population Pharmacokinetic ◽  
Binding Model ◽  
Saturable Binding ◽  
Drug Concentrations ◽  
Over Time

ABSTRACT VL-2397, a novel, systemic antifungal agent, has potent in vitro and in vivo fungicidal activity against Aspergillus species. Plasma concentrations from a phase 1 study were used to construct a population pharmacokinetic (PPK) model for VL-2397. Healthy subjects aged 18 to 55 years received single doses of VL-2397, ranging from 3 to 1,200 mg, multiple daily doses of 300, 600, or 1,200 mg for 7 days, or 300 mg three times/day for 7 days followed by 600 mg daily for 21 days. Plasma samples were collected throughout the dosing intervals. Sixty-six subjects provided 1,908 concentrations. Drug concentrations over time were increased less than dose proportionally for doses above 30 mg. Dose-normalized concentrations plotted over time did not overlap. A 3-compartment nonlinear saturable binding model fit the data well. Clearance increased with dose, and mean values ranged from 0.4 liters/h at 3 mg to 8.5 liters/h at 1,200 mg. Mean volume in the central compartment ranged from 4.8 to 6.9 liters across doses. In the first 24 h, once-daily dosing results in a rapid decrease in concentrations by hour 16 to approximately 1 mg/liter, regardless of dose, with slow clearance over time. Administration of 300 mg every 8 h achieved concentrations above 1 mg/liter over an entire 24-h period. There was a significant relationship between body surface area and clearance. The data suggest that VL-2397 has nonlinear saturable binding kinetics. Protein binding is the likely primary source of the nonlinearity. The PPK model can now be used to optimize dosing by bridging the kinetics to efficacious pharmacodynamic targets.

Phase I trial of recombinant interferon gamma in cancer patients.

1986 ◽  
Vol 4 (2) ◽  
pp. 137-146 ◽  
Author(s):  
S Vadhan-Raj ◽  
A Al-Katib ◽  
R Bhalla ◽  
L Pelus ◽  
C F Nathan ◽  
...  
Keyword(s):  
Interferon Gamma ◽  
Phase 1 ◽  
Rest Period ◽  
Lymphocytic Leukemia ◽  
Fixed Dose ◽  
Rapid Decline ◽  
Recombinant Interferon ◽  
Advanced Malignancy

Interferon gamma (IFN-gamma) is a lymphokine with potent in vitro effects on cell growth and immune function. We have investigated the effects of rIFN-gamma (sp act approximately 2 X 10(7) U/mg, purity greater than 99%) in 16 evaluable patients with advanced malignancy in a phase 1 trial. Patients were treated with six-hour intravenous (IV) infusions daily, five days a week for 2 weeks. After a 2-week rest period, the IV treatment cycle was repeated. Responders were maintained on repeated IV treatment cycles or daily intramuscular (IM) injections. Patients were entered at fixed dose levels of 0.1, 0.5, or 1.0 mg/m2/d. The maximum safely tolerated dose was 0.5 mg/m2. The most common side effects were constitutional symptoms, including fever, chills, fatigue, and myalgias. Reversible and transient increases in hepatic transaminase and decrease in granulocyte counts were seen. Treatment was associated with a dose-dependent increase in serum levels of beta 2 microglobulin. Partial responses (PRs) were observed in one patient with Hodgkin's disease and one patient with chronic lymphocytic leukemia. Fairly constant levels of serum IFN were found at four and six hours during infusion, followed by a rapid decline within one to two hours. We conclude that rIFN-gamma can be safely administered by a six-hour IV infusion and that it can induce in vivo some of the biologic effects reported in in vitro studies.

First in-human phase 1 trial of a novel amino-peptidase inhibitor, CHR-2797

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 3537-3537
Author(s):  
A. Protheroe ◽  
A. Reid ◽  
G. Attard ◽  
A. Davies ◽  
J. Spicer ◽  
...  
Keyword(s):  
Phase 1 ◽  
Single Patient ◽  
Once Daily ◽  
Apoptotic Protein ◽  
Peptidase Inhibitor ◽  
Orally Bioavailable ◽  
Ecog Ps ◽  
Continuous Dosing ◽  
Visual Disturbances ◽  
Potent Tumor

3537 Background: CHR-2797 is a novel, orally bioavailable agent which displays potent, tumor cell-selective, anti-proliferative properties. It is an inhibitor of Zn++-dependent aminopeptidases and generates signs of amino acid deprivation in sensitive cells, decreased protein synthesis and an increase in the level of the pro-apoptotic protein, Noxa. CHR-79888 is an active metabolite of CHR-2797. Patients and Methods: This study was conducted according to an accelerated titration design to define the MTD, DLT, toxicity profile and PK of CHR-2797 when administered orally for 28 days or longer. Patients (ECOG PS = 2) with histologically confirmed advanced solid tumors resistant or refractory to standard therapy were eligible. Results: 37 pts (median age 61.5 years [range 22.4–80.1]; 30M/7F; median ECOG PS 1; median prior regimens 2, range 0–6) enrolled in 12 cohorts (doses between 10 and 320mg). The first four patients received a 10 mg dose for 7, 14, 21 or 28 days respectively. Subsequent cohorts received 28 days continuous dosing, with dose doubling in single patient cohorts until drug-related toxicity = Grade 2. Thereafter the study followed a 3+3 design with = 40% dose increments. Common (gr 1–2) toxicity included fatigue (47%), diarrhea (47%), dizziness (24%), constipation, vomiting, abdominal pain (all 21%), and thrombocytopenia (18%). Toxicities show dose dependency for thrombocytopenia and fatigue. MTD was declared at 320 mg after 2 DLT’s were reported: 2 patients were unable to complete 28 days of daily dosing due to syncope/anemia, and dizziness/visual disturbances/thrombocytopenia, respectively. Patients recovered fully after cessation of the drug. The dose level below (240 mg) was expanded to 13 patients. Plasma PK was determined for both CHR-2797 and -79888, on days 1 and 28, which showed dose proportional increases in AUC and Cmax. Intracellular and intratumoral levels of both the parent and metabolite were also measured. So far 4 patients continued therapy for 7–9 months: one patient (RCC [130 mg]) achieved a PR, and 3 patients (ovarian ca [40 mg], NSCLC [130 mg], and breast ca [180 mg] had confirmed SD (> 3 months). Conclusion: Once daily oral CHR-2797 can be administered safely for 28 days in doses up to 240 mg and exhibits favorable PK. No significant financial relationships to disclose.

A phase I study of pazopanib (P) combined with bevacizumab (B) in patients with metastatic renal cell carcinoma (mRCC) or other advanced refractory tumors.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4614-4614
Author(s):  
Sylvie Negrier ◽  
David Pérol ◽  
Rastilav Bahleda ◽  
Antoine Hollebecque ◽  
Etienne Chatelut ◽  
...  
Keyword(s):  
Steady State ◽  
Kinase Inhibitors ◽  
Dose Finding ◽  
Uncontrolled Hypertension ◽  
Apparent Clearance ◽  
Finding Study ◽  
Treatment Naïve ◽  
Grade 3 ◽  
Vegfr Inhibitor ◽  
Ecog Ps

4614 Background: Since previous experiments of B with VEGFR tyrosine kinase inhibitors showed overlapping and limiting toxicities, a dose-finding study was designed to explore the safety and feasibility of the combination of a new VEGFR inhibitor P with B, in mRCC treatment-naive patients (pts) or in pts with other advanced refractory solid tumors. Methods: This bicentric trial is conducted with 3+3+3 escalation doses of P + B. The MTD is the highest dosage not expected to cause a dose limiting toxicity (DLT) in more than 2/3, 3/6 or finally 3/9 pts, during the first 8 weeks of treatment. The effect of B on steady-state pharmacokinetic (PK) of P is also investigated. Major inclusion criteria are: ECOG PS ≤1, ALT and AST <=2.5 x ULN, serum creatinine <=1.5 mg/dL or creatinine clearance <=50 mL/mn and absence of uncontrolled hypertension. Results: 15 pts were enrolled with mRCC (n=7), melanoma (n=2), adrenocortical carcinoma (n=1), mesothelioma (n=1), pancreatic cancer (n=1), oesophageal cancer (n=1), bladder cancer (n=1) and seminoma (n=1). Median age is 61 (43-78), 12 pts are male. No DLT were reported at DL1 (P 400 mg/d + B 7.5 mg/kg q2w) (n = 9), or at the first step of DL2 (P 600 mg/d + B 7.5 mg/kg q2) (n=3), but the 3 following nephrectomized pts experienced DLT: a grade 3 transaminitis, a grade 3 pulmonary embolism and a reversible microangiopathic hemolytic anemia. Inclusion of nephrectomized pts was completed, but enrolment of 3 additional non-nephrectomized pts at DL2 was approved by IDSMB in November 2011 and these treatments are ongoing. Preliminary results of PK analysis showed a significantly higher P AUC at steady-state in pts with DLT. Moreover, lower P apparent clearance was observed in nephrectomized pts. Conclusions: The MTD of the combination of P and B is 400 mg/d and 7.5mg/kg respectively, in nephrectomized patients, but is not yet reached in other patients. Unexpected effect of nephrectomy status was observed on P pharmacokinetics.

A phase I, dose-finding study of orally administered S-1 in combination with epirubicin and oxaliplatin (EOS) in patients (pts) with advanced or metastatic gastrointestinal cancer (AGIC) and chemonaïve advanced esophagogastric cancer (AEGC).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 140-140
Author(s):  
Markus Hermann Moehler ◽  
Volker Heinemann ◽  
Radka Obermannova ◽  
Eugen Kubala ◽  
Bohuslav Melichar ◽  
...  
Keyword(s):  
Phase I ◽  
Dose Level ◽  
Standard Dose ◽  
Dose Finding ◽  
Hematological Toxicity ◽  
First Line ◽  
Esophagogastric Cancer ◽  
Finding Study ◽  
Dose Finding Study ◽  
Ecog Ps

140 Background: S-1 (Teysuno), an oral fluoropyrimidine registered in Europe since 2011, provides a good efficacy and safety profile for the treatment (trt) of AEGC in combination with cisplatin. (FLAGS Study; J.A. Ajani. EJC2013). Because triplets with platinum compounds and anthracyclines are commonly used in AEGC, a phase I evaluating S-1 with fixed doses of oxaliplatin (130 mg/m² D1) and epirubicin (50 mg/m² D1) q3w in AGIC pts [cohorts 1 (C1) and 2 (C2)] and in chemonaïve AEGC pts [cohort 3 (C3)] was performed. Methods: Pts >18 years, ECOG/PS 0/1 were enrolled. Standard dose-limiting toxicity (DLT) evaluation was used. The maximum tolerate dose (MTD) was defined as the highest dose level at which less than <2/6 of pts experienced a DLT during Cycle 1. Once MTD was established, the cohort was expanded up to 12 pts. C1 and C2: S-1 dose was defined in cohort of pts (3+3 design): C1 20mg/m² BID (40 mg/m²/day); C2 25 mg/m² BID (50 mg/m²/d). Escalation to dose level (DL) 2 occurred only after DL1 (20mg/m²/BID) was safe according to DLT criteria. In C3 pts received S-1 25mg/m² BID. Results: 23 pts were evaluated. C1 and C2 included AGIC pts at all lines of trt. As in C1: 3 pts had no DLT, dose was increased and 3 pts were included in C2: after 1 DLT (≥Gr3 non-hematological toxicity), 2 more pts were included in C2 with a second DLT (febrile neutropenia). These 2 DLTs occurred in heavily pre-treated pts (3rd line) and led to closing of C2 and 3 additional pts were enrolled in expanded C1. MTD of S-1 was established 20 mg/m² BID. No DLT reported for chemo-naïve pts treated. Since EOS is used to treat AEGC in first line, a new C3 cohort with chemo-naïve pts was opened to again determine MTD of S-1: 6 pts in C3 were included. Here no DLT occurred and additional 6 pts confirmed dose of 25 mg/m² as the MTD. Conclusions: Based on these results, the recommended doses of S-1 in EOS regimen are 20 mg/m²/BID in heavily pre-treated AGIC pts and 25 mg/m²/BID in chemo-naïve AEGC pts. The triplets EOS could represent a well-tolerated alternative first line trt for AEGC pts. Clinical trial information: 2011-003471-11.

scholarly journals Phase 1 dose-finding study of rebastinib (DCC-2036) in patients with relapsed chronic myeloid leukemia and acute myeloid leukemia

Haematologica ◽  
2016 ◽  
Vol 102 (3) ◽  
pp. 519-528 ◽  
Author(s):  
Jorge Cortes ◽  
Moshe Talpaz ◽  
Hedy P. Smith ◽  
David S. Snyder ◽  
Jean Khoury ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Phase 1 ◽  
Dose Finding ◽  
Finding Study ◽  
Dose Finding Study ◽  
Acute Myeloid

scholarly journals A Phase 1 Study of the BET-Bromodomain Inhibitor OTX015 in Patients with Advanced Acute Leukemia

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 117-117 ◽  
Author(s):  
Hervé Dombret ◽  
Claude Preudhomme ◽  
Céline Berthon ◽  
Emmanuel Raffoux ◽  
Xavier Thomas ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Acute Leukemia ◽  
Research Funding ◽  
Phase 1 ◽  
Plasma Concentrations ◽  
Normal Karyotype ◽  
Refractory Anemia ◽  
Phase 1 Study ◽  
Grade 3

Abstract Rationale: BET-bromodomain (BRD) proteins play a major role in the epigenetic regulation of gene transcription, notably of genes with superenhancer promoter regions including many oncogenes, such as MYC. OTX015 is a specific BRD 2, 3 and 4 inhibitor that blocks oncogene transcription, and triggers growth inhibition and apoptosis in acute leukemia cell lines and patient cells in vitro (Braun et al. ASH Annual Meeting 2013). Based on these findings, a Phase 1 study of OTX015 was designed for patients with advanced acute leukemia. Patients & Methods: Patients with various unselected relapsed/refractory leukemia subtypes for which no standard therapy options were available were enrolled in this ongoing Phase 1 study. Patients aged < 60 years had to have failed at least two lines of therapy and those aged >60 years at least one line. At least 5% bone marrow leukemic blasts were required at study entry. OTX015 was given orally, daily for 14 days of 21-day cycles (cy). The dose was escalated from 10 to 160 mg daily (QD) according to a standard 3+3 dose-escalation design, to determine the maximum tolerated dose (MTD) or biologically optimal dose. A BID schedule was tested at dose level (DL) 4 (40 mg x 2) and a continuous schedule at 120 mg. Pharmacokinetics was studied on day 1 and residual concentrations were measured on days 2, 8 and 15. Responses were assessed on blood and bone marrow aspirations at baseline, days 8, 22 and 43. Blasts at baseline and day 8 were stored for pharmacodynamic biomarker evaluation. Cytogenetic and molecular markers were collected based on center practice. Results: From January 2013 to June 2014, 36 patients were treated over 6 dose levels: 33 with acute myeloid leukemia (AML), 2 with acute lymphoblastic leukemia and 1 with refractory anemia with excess blasts. Median age was 70 years (range 19-85), 20 patients were male, 29 patients had ECOG 0-1, and 16 AML patients had normal karyotype. Patients had a median of 2 prior therapy lines (range 1-4). The median number of OTX015 cycles administered was 2 (range 1-14+), including 9 patients with >3 cycles. Among the 28 patients evaluable for dose limiting toxicity (DLT), no DLTs were observed through DL5 (120 mg QD). The MTD was exceeded at DL6 (160 mg QD) with one patient experiencing grade 3 diarrhea and another grade 3 fatigue and anorexia. The main toxicities were non-cumulative grade 1-2 gastrointestinal events (6 patients diarrhea, 3 dysgueusia, 3 abdominal pain, 3 nausea, 1 anorexia), hyperglycemia (3 patients), coagulation factor VII decrease (6 patients) and direct bilirubin increase (3 patients) (two latter AEs asymptomatic). These toxicities were mainly observed at QD doses above 80 mg and with 40 mg BID. Dose proportional plasma concentrations were observed and trough concentrations > 500 nM (in vitro active concentrations) were regularly observed from 80 mg/day. Clinically relevant activity was reported in 5 AML patients treated at 10, 40 and 80 mg, including one sustained CR from cy 4 to cy 12 (40 mg QD) and one CR with incomplete platelet recovery (CRp) from cy 2 to cy 5 (80 mg QD). Two patients (10 mg QD, 40 mg QD) had partial blast clearance (disappearance of peripheral blasts and decrease >50% in bone marrow blast percentage) and the remaining patient (40 mg BID) had gum hypertrophy resolution. Four of these 5 patients had secondary or therapy-related AML, 4 had normal karyotype and 2 had an NPM1 gene mutation. Conclusions: OTX015 single agent exhibits antileukemic activity over a wide range of DLs and plasma concentrations in patients with advanced AML. MTD is exceeded at 160 mg QD. The safe recommended dose and schedule is close to being identified. Central extensive molecular marker analysis is being performed and will be prospectively implemented in an expansion cohort. Updated data will be presented and will include correlations between regimen, pharmacokinetics, clinical activity and molecular profile. Table Dose (Schedule) N pts evaluable Evidence of activity DLT 10 QD (14/21) 3 1 20 QD (14/21) 3 40 QD(14/21) 4 1 (CR) 80 QD(14/21) 3 2 (1 CRp) 40 BID (14/21) 6 1 120 QD (14/21) 3 120 QD (21/21) 3 160 QD (14/21) 3 Diarrhea (1) Anorexia/fatigue (1) Disclosures Dombret: Oncoethix SA: Research Funding. Preudhomme:Oncoethix SA: Research Funding. Berthon:Oncoethix SA: Research Funding. Raffoux:Oncoethix SA: Research Funding. Thomas:Oncoethix SA: Research Funding. Vey:Oncoethix SA: Research Funding. Gomez-Roca:Oncoethix SA: Research Funding. Ethell:Oncoethix SA: Research Funding. Yee:Oncoethix SA: Research Funding. Bourdel:Oncoethix SA: Employee of study CRO Other. Herait:Oncoethix SA: CMO and Shareholder Other. Michallet:Oncoethix SA: Research Funding. Recher:Oncoethix SA: Research Funding. Roumier:Oncoethix SA: Research Funding. Quesnel:Oncoethix SA: Research Funding.

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