Trial document

This study has been imported from without additional data checks.
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Trial Description

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Phase II Trial of CAP7.1 in Adult Patients With Refractory Malignancies: Small Cell Lung Carcinoma, Non-Small Cell Lung Carcinoma, Biliary Carcinoma (PIITCAP)

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Trial Acronym


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URL of the Trial


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Brief Summary in Lay Language

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 NSCLC, SCLC or biliary cancer who have progressed despite one or more
previous chemotherapy line.

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Brief Summary in Scientific Language

A phase II evaluation will be performed in adult patients in parallel studies in 3 tumor
types: NSCLC, SCLC and Biliary Tract Cancer. All patients will have advanced or metastatic
disease with primary or secondary resistance to standard therapy. In each tumor type the
patients will be randomized to receive either therapy with CAP7.1 or best supportive care
according to institution standards. Patient in the Control group who progress may cross over
to CAP7.1, however these patients will be analyzed separately from the patients randomized
to CAP7.1.

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Organizational Data

  •   DRKS00005236
  •   2014/04/02
  •   2014/03/18
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2012-002378-30 
  •   NCT02094560  (
  •   CPN710102  (CellAct Pharma GmbH)
  •   2012-002378-30 
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Health Condition or Problem studied

  •   Advanced Endstage Solid Carcinomas in Adults
  •   C34 -  Malignant neoplasm of bronchus and lung
  •   C22.1 -  Malignant neoplasm: Intrahepatic bile duct carcinoma
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Interventions/Observational Groups

  •   Drug: CAP7.1
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  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Time to disease progression; time frame: 18 month; Assessment of antitumor activity based on RECIST 1.1 criteria (complete response; partial response; stable disease)

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Secondary Outcome

- Efficacy; time frame: 18 months; Assessment of overall survival (OS)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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  •   [---]*
  •   2011/11/30
  •   150
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- Histologically- or cytologically-confirmed, advanced disease with documented
progression (RECIST1.1.) after one or several chemotherapy line

- Patients may also have received molecular targeted therapy and progressed while on
therapy or after completion

- Must have recovered from the acute reversible effects of previous anti-cancer
chemotherapy, usually 3-4 weeks after myelosuppressive chemotherapy

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Exclusion Criteria

- Serious concurrent medical condition, which could affect compliance with the protocol
or interpretation of results.

- Patients with uncontrolled infection and patients known to be infected with the human
immunodeficiency virus (HIV) or hepatitis infection are not eligible for the study

- Pregnancy or breast-feeding

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  • start of 1:1-Block address primary-sponsor
    • CellAct Pharma GmbH
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    •   [---]*
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    • Nalân Utku, M.D. Ph.D. 
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    • Nalân Utku, M.D. Ph.D. 
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Sources of Monetary or Material Support

  • [---]*
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  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in and DRKS are not identical. Therefore the data import from required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.