Clinical Trial Results:
Nab-Paclitaxel (Abraxane®) and Gemcitabine as first line therapy in patients with cholangiocarcinoma ineligible for cisplatin-based chemotherapy – a pilot study
The NACHO trial (GEMNABCCC-001)
Summary
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EudraCT number |
2014-004981-52 |
Trial protocol |
DE |
Global end of trial date |
10 Oct 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Aug 2022
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First version publication date |
15 Aug 2022
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Other versions |
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Summary report(s) |
CSR_2014-004981-52 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GEMNABCCC-001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
AX-CL-OTHER-PI-003916 : Celgene number | ||
Sponsors
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Sponsor organisation name |
University Hospital Essen
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Sponsor organisation address |
Hufelandstr. 55, Essen, Germany, 45147
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Public contact |
PI, University Hospital Essen, +49 02017231791, gabriele.linden@uk-essen.de
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Scientific contact |
PI, University Hospital Essen, +49 02017231791, gabriele.linden@uk-essen.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Jul 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 Oct 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Oct 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Primary objective:
To determine the efficacy of Gemcitabine/nab-Paclitaxel in first-line therapy of patients with cholangiocarcinoma ineligible for Cisplatin-based therapy. Results of the first 10 evaluable patients will be compared to patient outcomes from the cancer registry of the West German Cancer Center (patients treated with Gemcitabine-combinations, patients treated with monotherapies). Primary endpoint will be overall response rate (ORR) (complete remission and partial remission)
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Protection of trial subjects |
AE were measured at every visit.
The regulatory basis of the conduct of this study consisted of the Declaration of Helsinki (in its current version), the AMG [German Medicinal Products Act], in particular Sections 40-42 in the current versions, the guidelines of Good Clinical Practice (ICH-GCP: International Conference on Harmonisation –Good Clinical Practice) valid since 17-Jan-1997, and the GCP-regulation of 09-Aug-2004 (last change of 15-Mar-2006).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Jan 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
10
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
7
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment 06.Dec2016 - 05.Jul 2017 | ||||||
Pre-assignment
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Screening details |
all screened patients were registered. in total, 10 patients started therapy. There was no screen failure | ||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Nab-Paclitaxel and Gemcitabine | ||||||
Arm description |
Nab-Paclitaxel (Abraxane®) and Gemcitabine | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
nab-paclitaxel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Nab-Paclitaxel (Abraxane®)
125mg/m² i.v. day 1, 8, 15
for patients with bilirubin 1.5-3ULN
Nab-Paclitaxel (Abraxane®)
100mg/m² i.v. day 1, 8, 15
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Investigational medicinal product name |
Gemcitabine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Gemcitabine
1000mg/m² i.v. day 1, 8, 15
repeat the cycle at day 28, until disease progression
For Patients with elevated bilirubin values >1.5-3x ULN):
Gemcitabine
800mg/m² i.v. day 1, 8, 15
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End points reporting groups
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Reporting group title |
Nab-Paclitaxel and Gemcitabine
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Reporting group description |
Nab-Paclitaxel (Abraxane®) and Gemcitabine | ||
Subject analysis set title |
ITT
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Intention-To-treat population
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End point title |
Objective Response Rate (ORR) [1] | ||||||||
End point description |
Altogether 10 patients were enrolled into the trial and received at least one cycle of chemotherapy (ITT-population), In total 4 of the ITT set had CR or PR as best response; this amounted to an ORR of 40%.
DCR (CR+PR+SD) was 80%.
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End point type |
Primary
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End point timeframe |
Registration to EOS
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: see full data set |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Screening to EOS
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
3.0
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Frequency threshold for reporting non-serious adverse events: 1% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: see full data set |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |