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NCT02094560: CAP7-1

CAP7.1 for the Treatment of Advanced Stage, Therapy Refractory Lung and Biliary Tract Tumors

Terminated Phase 2 Last updated 5 September 2018
What this trial tests

Phase 2 trial testing CAP7.1 in Advanced Endstage Solid Carcinomas in Adults in 45 participants. Terminated before completion.

Timeline
8 November 2011
Primary endpoint
8 September 2015
10 April 2017

Quick facts

Lead sponsorCellAct Pharma GmbH
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment45
Start date8 November 2011
Primary completion8 September 2015
Estimated completion10 April 2017
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

CellAct Pharma GmbH — full company profile →

Who can join

Eligibility, any sex, with Advanced Endstage Solid Carcinomas in Adults. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To assess the anti-tumor activity of CAP7.1 based on the observed objective response rate and rate of disease stabilization, as defined by the below primary and secondary endpoints, in patients with Non-Small Cell Lung Carcinoma (NSCLC), SCLC or biliary cancer who have progressed despite one or more previous chemotherapy line.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy and Safety of CAP7.1 as Second-Line Treatment for Advanced Biliary Tract Cancers: Data from a Randomised Phase II Study.
    Pape UF, Kasper S, Meiler J, Sinn M, et al · · 2020 · cited 2× · PMID 33121007 · DOI 10.3390/cancers12113149

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