Serotonin Syndrome News

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||||||||||  vatalanib (PTK787) / Novartis, Bayer
Trial primary completion date, Combination therapy, Metastases:  Everolimus and Vatalanib in Treating Patients With Advanced Solid Tumors (clinicaltrials.gov) -  Jun 19, 2014
P1, N=96, Active, not recruiting,  Sponsor: Mayo Clinic
Trial primary completion date: Sep 2014 --> Dec 2014

||||||||||  Avastin (bevacizumab) / Roche, Torisel (temsirolimus) / Pfizer
Enrollment open:  Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer (clinicaltrials.gov) -  Apr 3, 2014
P2, N=299, Recruiting,  Sponsor: National Cancer Institute (NCI)
Trial primary completion date: Sep 2014 --> Dec 2014 Suspended --> Recruiting

||||||||||  trebananib (AMG 386) / Amgen, Torisel (temsirolimus) / Pfizer
Enrollment closed, Surgery, Metastases:  Trebananib And Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (clinicaltrials.gov) -  Mar 31, 2014
P1, N=60, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
Suspended --> Recruiting Recruiting --> Active, not recruiting

||||||||||  cixutumumab (IMC A12) / Eli Lilly
Enrollment change, Metastases:  Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma (clinicaltrials.gov) -  Mar 19, 2014
P1, N=19, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
Recruiting --> Active, not recruiting N=48 --> 19

||||||||||  Xermelo (telotristat etiprate) / Ipsen, Lexicon Pharma, TerSera Therap
Enrollment open:  TELECAST: Telotristat Etiprate for Carcinoid Syndrome Therapy (clinicaltrials.gov) -  Feb 27, 2014
P3, N=100, Recruiting,  Sponsor: Lexicon Pharmaceuticals
N=48 --> 19 Not yet recruiting --> Recruiting

||||||||||  Signifor (pasireotide) / Recordati
Trial completion, Metastases:  Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors (clinicaltrials.gov) -  Feb 22, 2014
P2, N=45, Completed,  Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  gefitinib / Generic mfg.
Trial completion, Metastases:  Gefitinib in Treating Patients With Progressive Metastatic Neuroendocrine Tumors (clinicaltrials.gov) -  Feb 22, 2014
P2, N=90, Completed,  Sponsor: National Cancer Institute (NCI)
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Avastin (bevacizumab) / Roche, ViraferonPeg (peginterferon-?-2b) / Merck (MSD)
Trial completion, Metastases:  Bevacizumab and PEG-Interferon Alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors (clinicaltrials.gov) -  Feb 22, 2014
P2, N=44, Completed,  Sponsor: National Cancer Institute (NCI)
Active, not recruiting --> Completed No longer recruiting --> Completed

||||||||||  thalidomide / Generic mfg.
Trial completion, Metastases:  Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors (clinicaltrials.gov) -  Feb 22, 2014
P2, N=0, Completed,  Sponsor: Memorial Sloan-Kettering Cancer Center
No longer recruiting --> Completed Active, not recruiting --> Completed

||||||||||  carboplatin / Generic mfg., cisplatin / Generic mfg., floxuridine / Generic mfg.
Trial completion:  Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer (clinicaltrials.gov) -  Feb 19, 2014
P2, N=45, Completed,  Sponsor: New York University School of Medicine
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  NN1213 / Novo Nordisk
Trial completion:  Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction (clinicaltrials.gov) -  Feb 19, 2014
P1/2, N=0, Completed,  Sponsor: Northwestern University
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  NN1213 / Novo Nordisk
Trial completion:  Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction (clinicaltrials.gov) -  Feb 19, 2014
P1/2, N=0, Completed,  Sponsor: Northwestern University
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Herceptin (trastuzumab) / Roche
Trial completion:  Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu (clinicaltrials.gov) -  Feb 19, 2014
P1, N=15, Completed,  Sponsor: National Cancer Institute (NCI)
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  oxaliplatin / Generic mfg., irinotecan / Generic mfg.
Trial completion, Metastases:  Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer (clinicaltrials.gov) -  Feb 19, 2014
P1, N=36, Completed,  Sponsor: Memorial Sloan-Kettering Cancer Center
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Xermelo (telotristat etiprate) / Ipsen, Lexicon Pharma, TerSera Therap
Trial completion:  Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome (clinicaltrials.gov) -  Feb 19, 2014
P2, N=15, Completed,  Sponsor: Lexicon Pharmaceuticals
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Xermelo (telotristat etiprate) / Ipsen, Lexicon Pharma, TerSera Therap
New P3 trial:  TELECAST: Telotristat Etiprate for Carcinoid Syndrome Therapy (clinicaltrials.gov) -  Feb 12, 2014
P3, N=100, Recruiting,  Sponsor: Lexicon Pharmaceuticals

||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment change, Metastases:  Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer (clinicaltrials.gov) -  Feb 9, 2014
P1/2, N=43, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
Active, not recruiting --> Completed N=55 --> 43

||||||||||  SVV-001 / Seneca Therap
Enrollment change:  Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features (clinicaltrials.gov) -  Jan 28, 2014
P1, N=22, Completed,  Sponsor: Children's Oncology Group
N=55 --> 43 N=51 --> 22

||||||||||  SVV-001 / Seneca Therap
Trial completion:  Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features (clinicaltrials.gov) -  Jan 28, 2014
P1, N=22, Completed,  Sponsor: Children's Oncology Group
N=51 --> 22 Recruiting --> Completed

||||||||||  Sandostatin LAR Depot (octreotide acetate) / Novartis
Enrollment open:  P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome (clinicaltrials.gov) -  Dec 10, 2013
P2, N=30, Recruiting,  Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  Xermelo (telotristat etiprate) / Ipsen, Lexicon Pharma, TerSera Therap
Trial completion:  An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males (clinicaltrials.gov) -  Oct 21, 2013
P1, N=8, Completed,  Sponsor: Lexicon Pharmaceuticals
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  octreotide implant (VP-003) / Endo
Enrollment change:  Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome (clinicaltrials.gov) -  Sep 8, 2013
P1/2, N=10, Terminated,  Sponsor: Endo Pharmaceuticals
Active, not recruiting --> Completed N=20 --> 10

||||||||||  Xermelo (telotristat etiprate) / Ipsen, Lexicon Pharma, TerSera Therap
New P1 trial:  An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males (clinicaltrials.gov) -  Aug 28, 2013
P1, N=8, Completed,  Sponsor: Lexicon Pharmaceuticals

||||||||||  Zanosar (streptozocin) / Teva
Trial completion, Metastases:  Capecitabine and Streptozocin With or Without Cisplatin in Treating Patients With Unresectable or Metastatic Neuroendocrine Tumors (clinicaltrials.gov) -  Aug 5, 2013
P2, N=84, Completed,  Sponsor: Cambridge University Hospitals NHS Foundation Trust
N=20 --> 10 Recruiting --> Completed

||||||||||  trebananib (AMG 386) / Amgen, Torisel (temsirolimus) / Pfizer
Enrollment change, Surgery, Metastases:  Trebananib And Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (clinicaltrials.gov) -  Jul 29, 2013
P1, N=60, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
Recruiting --> Completed N=42 --> 60

||||||||||  Vectibix (panitumumab) / Amgen
Trial withdrawal:  Study of Panitumumab in the Treatment of Carcinoid Syndrome (clinicaltrials.gov) -  Jul 24, 2013
P2, N=0, Withdrawn,  Sponsor: Boston Medical Center
N=42 --> 60 Not yet recruiting --> Withdrawn

||||||||||  Vectibix (panitumumab) / Amgen
Enrollment change:  Study of Panitumumab in the Treatment of Carcinoid Syndrome (clinicaltrials.gov) -  Jul 24, 2013
P2, N=0, Withdrawn,  Sponsor: Boston Medical Center
Not yet recruiting --> Withdrawn N=20 --> 0

||||||||||  7-Hydroxystaurosporine (UCN-01) / National Cancer Institute
Trial completion, Combination therapy, Metastases:  7-Hydroxystaurosporine and Irinotecan Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Triple Negative Breast Cancer (Currently Accruing Only Triple-negative Breast Cancer Patients Since 6/8/2007) (clinicaltrials.gov) -  Jun 30, 2013
P1, N=41, Completed,  Sponsor: National Cancer Institute (NCI)
N=20 --> 0 Active, not recruiting --> Completed

||||||||||  Sandostatin LAR Depot (octreotide acetate) / Novartis
New P2 trial:  P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome (clinicaltrials.gov) -  Jun 23, 2013
P2, N=30, Recruiting,  Sponsor: H. Lee Moffitt Cancer Center and Research Institute

||||||||||  Istodax (romidepsin) / Astellas, BMS
Trial termination, Metastases:  Romidepsin in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors (clinicaltrials.gov) -  Jun 2, 2013
P2, N=25, Terminated,  Sponsor: National Cancer Institute (NCI)
Active, not recruiting --> Completed Active, not recruiting --> Terminated

|||||||||| Trial completion: Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer (clinicaltrials.gov) - Apr 29, 2013
P1, N=60, Completed, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Terminated Active, not recruiting --> Completed

||||||||||  Vectibix (panitumumab) / Amgen
Trial initiation date:  Study of Panitumumab in the Treatment of Carcinoid Syndrome (clinicaltrials.gov) -  Jan 15, 2013
P2, N=0, Withdrawn,  Sponsor: Boston Medical Center
Active, not recruiting --> Completed Initiation date: Jul 2012 --> Jul 2013

|||||||||| Trial termination, Tumor cell: EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jan 14, 2013
P=N/A, N=30, Terminated, Sponsor: National Cancer Institute (NCI)
Initiation date: Jul 2012 --> Jul 2013 Completed --> Terminated; Administratively complete.

||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment closed, Metastases:  Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer (clinicaltrials.gov) -  Jan 7, 2013
P1/2, N=43, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
Completed --> Terminated; Administratively complete. Recruiting --> Active, not recruiting

||||||||||  cixutumumab (IMC A12) / Eli Lilly
Enrollment closed, Metastases:  Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma (clinicaltrials.gov) -  Oct 23, 2012
P1, N=19, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting

||||||||||  Xermelo (telotristat etiprate) / Ipsen, Lexicon Pharma, TerSera Therap
Enrollment open:  TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome) (clinicaltrials.gov) -  Oct 21, 2012
P3, N=105, Recruiting,  Sponsor: Lexicon Pharmaceuticals
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

||||||||||  Xermelo (telotristat etiprate) / Ipsen, Lexicon Pharma, TerSera Therap
New P3 trial:  TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome) (clinicaltrials.gov) -  Aug 30, 2012
P3, N=105, Recruiting,  Sponsor: Lexicon Pharmaceuticals

||||||||||  octreotide implant (VP-003) / Endo
Trial termination:  Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome (clinicaltrials.gov) -  Aug 15, 2012
P1/2, N=10, Terminated,  Sponsor: Endo Pharmaceuticals
Not yet recruiting --> Recruiting Active, not recruiting --> Terminated; Program was terminated for business reasons

|||||||||| Enrollment change: Effects of Serotonin Excess on Bone in Carcinoid Syndrome (clinicaltrials.gov) - Jun 13, 2012
P=N/A, N=52, Completed, Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Active, not recruiting --> Terminated; Program was terminated for business reasons N=120 --> 52

|||||||||| Trial completion: Effects of Serotonin Excess on Bone in Carcinoid Syndrome (clinicaltrials.gov) - Jun 13, 2012
P=N/A, N=52, Completed, Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
N=120 --> 52 Recruiting --> Completed

||||||||||  Torisel (temsirolimus) / Pfizer
Trial completion, Metastases:  Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma (clinicaltrials.gov) -  Jun 12, 2012
P2, N=35, Completed,  Sponsor: National Cancer Institute (NCI)
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  trebananib (AMG 386) / Amgen, Torisel (temsirolimus) / Pfizer
New P1 trial, Surgery, Metastases:  Trebananib And Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (clinicaltrials.gov) -  Mar 6, 2012
P1, N=60, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)

||||||||||  Torisel (temsirolimus) / Pfizer
Enrollment closed, Metastases:  Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors (clinicaltrials.gov) -  Jan 31, 2012
P1, N=19, Active, not recruiting,  Sponsor: University of Southern California
Active, not recruiting --> Completed Recruiting --> Active, not recruiting



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