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1.
2.

Accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimised multi-arm phase I/II trial design.

Richert L, Doussau A, Lelièvre JD, Arnold V, Rieux V, Bouakane A, Lévy Y, Chêne G, Thiébaut R; Vaccine Research Institute (VRI).

Trials. 2014 Feb 26;15:68. doi: 10.1186/1745-6215-15-68.

PMID:
24571662
[PubMed - in process]
Free PMC Article
3.

Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test.

Kwak M, Jung SH.

Stat Med. 2014 May 30;33(12):2004-16. doi: 10.1002/sim.6073. Epub 2013 Dec 13.

PMID:
24338995
[PubMed - in process]
Free PMC Article
4.

Phase II trial design with Bayesian adaptive randomization and predictive probability.

Yin G, Chen N, Lee JJ.

J R Stat Soc Ser C Appl Stat. 2012 Mar 1;61(2). doi: 10.1111/j.1467-9876.2011.01006.x.

PMID:
24259753
[PubMed]
Free PMC Article
5.

Vincristine chemotherapy trials and pharmacokinetics in tasmanian devils with tasmanian devil facial tumor disease.

Phalen DN, Frimberger A, Pyecroft S, Peck S, Harmsen C, Lola S, de Mello Mattos B, Li KM, McLachlan AJ, Moore A.

PLoS One. 2013 Jun 6;8(6):e65133. doi: 10.1371/journal.pone.0065133. Print 2013.

PMID:
23762298
[PubMed - indexed for MEDLINE]
Free PMC Article
6.

What inference for two-stage phase II trials?

Porcher R, Desseaux K.

BMC Med Res Methodol. 2012 Aug 6;12:117.

PMID:
22867439
[PubMed - indexed for MEDLINE]
Free PMC Article
7.

A method for utilizing co-primary efficacy outcome measures to screen regimens for activity in two-stage Phase II clinical trials.

Sill MW, Rubinstein L, Litwin S, Yothers G.

Clin Trials. 2012 Aug;9(4):385-95. doi: 10.1177/1740774512450101. Epub 2012 Jul 18.

PMID:
22811448
[PubMed - indexed for MEDLINE]
Free PMC Article
8.

A phase II trial to assess efficacy and safety of afatinib in extensively pretreated patients with HER2-negative metastatic breast cancer.

Schuler M, Awada A, Harter P, Canon JL, Possinger K, Schmidt M, De Grève J, Neven P, Dirix L, Jonat W, Beckmann MW, Schütte J, Fasching PA, Gottschalk N, Besse-Hammer T, Fleischer F, Wind S, Uttenreuther-Fischer M, Piccart M, Harbeck N.

Breast Cancer Res Treat. 2012 Aug;134(3):1149-59. doi: 10.1007/s10549-012-2126-1. Epub 2012 Jul 5.

PMID:
22763464
[PubMed - indexed for MEDLINE]
Free PMC Article
9.

Bayesian decision theoretic two-stage design in phase II clinical trials with survival endpoint.

Zhao L, Taylor JM, Schuetze SM.

Stat Med. 2012 Jul 30;31(17):1804-20. doi: 10.1002/sim.4511. Epub 2012 Feb 23.

PMID:
22359354
[PubMed - indexed for MEDLINE]
10.

A comparison of a new multinomial stopping rule with stopping rules of fleming and gehan in single arm phase II cancer clinical trials.

Goffin JR, Pond GR, Tu D.

BMC Med Res Methodol. 2011 Jun 21;11:95. doi: 10.1186/1471-2288-11-95.

PMID:
21693051
[PubMed - indexed for MEDLINE]
Free PMC Article
11.

Continuous low-dose cyclophosphamide and methotrexate combined with celecoxib for patients with advanced cancer.

Khan OA, Blann AD, Payne MJ, Middleton MR, Protheroe AS, Talbot DC, Taylor M, Kirichek O, Han C, Patil M, Harris AL.

Br J Cancer. 2011 Jun 7;104(12):1822-7. doi: 10.1038/bjc.2011.154. Epub 2011 May 17. Erratum in: Br J Cancer. 2011 Oct 11;105(8):1252. Kirichek, O [added].

PMID:
21587257
[PubMed - indexed for MEDLINE]
Free PMC Article
12.

Phase II study of single agent capecitabine in the treatment of metastatic non-pancreatic neuroendocrine tumours.

Medley L, Morel AN, Farrugia D, Reed N, Hayward N, Davies JM, Kirichek O, Thakker RV, Talbot DC.

Br J Cancer. 2011 Mar 29;104(7):1067-70. doi: 10.1038/bjc.2011.76. Epub 2011 Mar 8.

PMID:
21386841
[PubMed - indexed for MEDLINE]
Free PMC Article
13.

Efficacy of sunitinib in advanced medullary thyroid carcinoma: intermediate results of phase II THYSU.

Ravaud A, de la Fouchardière C, Asselineau J, Delord JP, Do Cao C, Niccoli P, Rodien P, Klein M, Catargi B.

Oncologist. 2010;15(2):212-3; author reply 214. doi: 10.1634/theoncologist.2009-0303. No abstract available.

PMID:
20189981
[PubMed - indexed for MEDLINE]
Free PMC Article
14.

Improving outcome of chemotherapy of metastatic breast cancer by docosahexaenoic acid: a phase II trial.

Bougnoux P, Hajjaji N, Ferrasson MN, Giraudeau B, Couet C, Le Floch O.

Br J Cancer. 2009 Dec 15;101(12):1978-85. doi: 10.1038/sj.bjc.6605441. Epub 2009 Nov 17.

PMID:
19920822
[PubMed - indexed for MEDLINE]
Free PMC Article
15.

Neoadjuvant continuous infusion of weekly 5-fluorouracil and escalating doses of oxaliplatin plus concurrent radiation in locally advanced oesophageal squamous cell carcinoma: results of a phase I/II trial.

Lorenzen S, Brücher B, Zimmermann F, Geinitz H, Riera J, Schuster T, Roethling N, Höfler H, Ott K, Peschel C, Siewert JR, Molls M, Lordick F.

Br J Cancer. 2008 Oct 7;99(7):1020-6. doi: 10.1038/sj.bjc.6604659. Epub 2008 Sep 16.

PMID:
18797462
[PubMed - indexed for MEDLINE]
Free PMC Article
16.

Cisplatin and vinorelbine first-line chemotherapy in non-resectable malignant pleural mesothelioma.

Sørensen JB, Frank H, Palshof T.

Br J Cancer. 2008 Jul 8;99(1):44-50. doi: 10.1038/sj.bjc.6604421. Epub 2008 Jun 10.

PMID:
18542078
[PubMed - indexed for MEDLINE]
Free PMC Article
17.

Bayesian optimal design for phase II screening trials.

Ding M, Rosner GL, Müller P.

Biometrics. 2008 Sep;64(3):886-94. Epub 2007 Dec 20.

PMID:
18162113
[PubMed - indexed for MEDLINE]
Free PMC Article
18.

Phase II Trial of Doxorubicin Plus Escalated High-Dose Ifosfamide in Patients With Advanced Soft Tissue Sarcomas of the Adult: A Study of the Spanish Group for Research on Sarcomas (GEIS).

López-Pousa A, Martín J, Montalar J, de Las Peñas R, García Del Muro J, Cruz J, Maurel J, Escudero P, Casado A, Buesa JM, The Spanish Group For Research On Sarcomas Geis.

Sarcoma. 2006;2006:26986.

PMID:
17251655
[PubMed]
Free PMC Article
19.

A phase I/II study of lomustine and temozolomide in patients with cerebral metastases from malignant melanoma.

Larkin JM, Hughes SA, Beirne DA, Patel PM, Gibbens IM, Bate SC, Thomas K, Eisen TG, Gore ME.

Br J Cancer. 2007 Jan 15;96(1):44-8. Epub 2006 Dec 5.

PMID:
17146474
[PubMed - indexed for MEDLINE]
Free PMC Article
20.

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