Clinical Trial Results:
An Open Label Phase II Study of Tipifarnib in Advanced Squamous Non-small Cell Lung Cancer with HRAS mutations
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Summary
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EudraCT number |
2017-004822-13 |
Trial protocol |
ES |
Global end of trial date |
09 Nov 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Nov 2023
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First version publication date |
01 Nov 2023
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Other versions |
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Summary report(s) |
THOMAS_summary final report |
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 |
GECP17/04
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03496766 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Fundación GECP
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Sponsor organisation address |
Avda. Meridiana 358, Barcelona, Spain, 08027
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Public contact |
Eva Pereira, Fundación GECP, +34 934302006, epereira@gecp.org
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Scientific contact |
Eva Pereira, Fundación GECP, +34 934302006, epereira@gecp.org
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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 |
13 Mar 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Oct 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Nov 2022
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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 |
To determine the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, squamous non-small cell lung cancer (SQ-NSCLC) with HRAS mutations. This objective will be evaluated in the treatment phase of the study.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP)
Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 May 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Spain: 9
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Worldwide total number of subjects |
9
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EEA total number of subjects |
9
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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) |
8
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
Between July 2018 and July 2022, a total of 43 9 patients were enrolled in the study, no patient was finally considered as an inclusion error. Finally 9 patients from 7 different sites were considered for the analysis. The recruitment was closed prematurely to due to slow recruitment. | ||||||
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Pre-assignment
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Screening details |
This Phase II study consists of 2 parts: 1) pre-screening phase and 2) treatment phase. The pre-screening phase will investigate the presence of HRAS mutations in subjects with a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (SQ-NSCLC). | ||||||
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Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Experimental | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Tipifarnib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Tipifarnib will be administered with food at a starting dose of 600 mg, daily on days 1-7 and 15-21 of 28-day treatment cycles. In the absence of unmanageable toxicities, subjects may continue to receive tipifarnib treatment for up to 24 months in the absence of disease progression and unmanageable toxicity. Treatment may continue beyond 24 months if there is documented evidence of continued clinical benefit.
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Baseline characteristics reporting groups
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Reporting group title |
Overall study (overall period)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Experimental
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Reporting group description |
- | ||
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End point title |
Overall response [1] | ||||||||||||
End point description |
To determine the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with locally
advanced unresectable or metastatic, relapsed and/or refractory, squamous non-small cell lung cancer (SQ-NSCLC)
with HRAS mutations
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End point type |
Primary
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End point timeframe |
From the first dose until progression disease, assessed from the first dose until the first assessment at week 6 from the
first dose.
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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: The recruitment was closed prematurely to due to slow recruitment, so there are no consistent data to achieve any relevant conclusion. All 9 evaluable patients in the efficacy cohort started treatment and subsequently failed. Of the 9 patients included, 8 (88.9%) patients have a disease progression and 1 (11.1%) died before performing first tumor assessment evaluation. 2 patients out of the 8 evaluable patients achieved SD, the rest of patients progressed. Thus, objective response rate was 0%. |
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End point title |
Progression Free Survival | ||||||||
End point description |
Defined as the time from the start date of treatment TMT as the origin of follow-up and the first progression or death as final date
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End point type |
Secondary
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End point timeframe |
From the start of treatment until first progression or death.
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End point title |
Overall Survival | ||||||||
End point description |
Defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with
the disease are still alive.
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End point type |
Secondary
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End point timeframe |
From the date of randomization until end of follow up.
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Adverse events information
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Timeframe for reporting adverse events |
Any adverse event or breakdown occurring during the course of the study.
The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 30 days after the last dose study treatment administration.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12.1
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Reporting groups
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Reporting group title |
As-treated population
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
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11 Dec 2019 |
Change in selection criteria and schedule of the study to improve study management. |
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04 Feb 2022 |
The sponsor change from GECP group to Fundation GECP. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? Yes | |||||||
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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. | |||||||
| The recruitment and study were closed prematurally due to slow recruitment. | |||||||
