Back to resultsCAP7.1 for the Treatment of Advanced Stage, Therapy Refractory Lung and Biliary Tract Tumors (CAP7-1)
Primary Purpose
Advanced Endstage Solid Carcinomas in Adults
Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
CAP7.1
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Endstage Solid Carcinomas in Adults focused on measuring therapy refractory, endstage, solid tumours
Eligibility Criteria
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
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
Sites / Locations
- Charite, University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Small cell lung cancer
Non small cell lung cancer
biliary tract cancer
Arm Description
Histologically- or cytologically-confirmed, limited and extensive SCLC disease with progression after first or second line treatment
Histologically- or cytologically-confirmed diagnosis of NSCLC with Stage IIIB or IV after failure of at least two lines of therapy
Histologically or cytologically confirmed diagnosis of biliary tract cancer progress after first line therapy
Outcomes
Primary Outcome Measures
Time to disease progression
Assessment of antitumor activity based on RECIST 1.1 criteria (complete response; partial response; stable disease)
Secondary Outcome Measures
1. Percentage of Subjects With Objective Response [i.e., complete response (CR) + partial response (PR)] According to RECIST1.1
Time to Treatment Failure
Progression-Free Survival (PFS)
Disease-free survival
Overall Survival (OS)
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Maximum Observed Drug Concentration (Cmax) of CAP7.1 in Plasma
Time to Reach Maximum Drug Concentration (tmax) of CAP7.1 in Plasma
Half-life Associated With the Terminal Slope (t1/2) of CAP7.1 in Plasma
Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of CAP7.1 in Plasma
Full Information
NCT ID
NCT02094560
First Posted
March 18, 2014
Last Updated
August 31, 2018
Sponsor
CellAct Pharma GmbH
Collaborators
Mundipharma-EDO GmbH
1. Study Identification
Unique Protocol Identification Number
NCT02094560
Brief Title
CAP7.1 for the Treatment of Advanced Stage, Therapy Refractory Lung and Biliary Tract Tumors
Acronym
CAP7-1
Official Title
Phase II Trial of CAP7.1 in Adult Patients With Refractory Malignancies: Small Cell Lung Carcinoma, Non-Small Cell Lung Carcinoma, Biliary Carcinoma (PIITCAP)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated to be redesigned for a trial according to EMA proposal.
Study Start Date
November 8, 2011 (Actual)
Primary Completion Date
September 8, 2015 (Actual)
Study Completion Date
April 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CellAct Pharma GmbH
Collaborators
Mundipharma-EDO GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Endstage Solid Carcinomas in Adults
Keywords
therapy refractory, endstage, solid tumours
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Small cell lung cancer
Arm Type
Experimental
Arm Description
Histologically- or cytologically-confirmed, limited and extensive SCLC disease with progression after first or second line treatment
Arm Title
Non small cell lung cancer
Arm Type
Experimental
Arm Description
Histologically- or cytologically-confirmed diagnosis of NSCLC with Stage IIIB or IV after failure of at least two lines of therapy
Arm Title
biliary tract cancer
Arm Type
Experimental
Arm Description
Histologically or cytologically confirmed diagnosis of biliary tract cancer progress after first line therapy
Intervention Type
Drug
Intervention Name(s)
CAP7.1
Intervention Description
CAP7.1 is a prodrug of Etoposide released after via specific carboxyesterase
Primary Outcome Measure Information:
Title
Time to disease progression
Description
Assessment of antitumor activity based on RECIST 1.1 criteria (complete response; partial response; stable disease)
Time Frame
18 month
Secondary Outcome Measure Information:
Title
1. Percentage of Subjects With Objective Response [i.e., complete response (CR) + partial response (PR)] According to RECIST1.1
Time Frame
Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Title
Time to Treatment Failure
Time Frame
Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Title
Progression-Free Survival (PFS)
Time Frame
Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Title
Disease-free survival
Time Frame
Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Title
Overall Survival (OS)
Time Frame
Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Title
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Time Frame
Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Title
Maximum Observed Drug Concentration (Cmax) of CAP7.1 in Plasma
Time Frame
Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Title
Time to Reach Maximum Drug Concentration (tmax) of CAP7.1 in Plasma
Time Frame
Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Title
Half-life Associated With the Terminal Slope (t1/2) of CAP7.1 in Plasma
Time Frame
Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Title
Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of CAP7.1 in Plasma
Time Frame
Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Facility Information:
Facility Name
Charite, University Hospital
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
28531881
Citation
Keilholz U, Rohde L, Mehlitz P, Knoedler M, Schmittel A, Kummerlen V, Klinghammer K, Treasure P, Lassus M, Steventon G, Machacek M, Utku N. First-in-man dose escalation and pharmacokinetic study of CAP7.1, a novel prodrug of etoposide, in adults with refractory solid tumours. Eur J Cancer. 2017 Jul;80:14-25. doi: 10.1016/j.ejca.2017.03.032. Epub 2017 May 19.
Results Reference
derived
Learn more about this trial
CAP7.1 for the Treatment of Advanced Stage, Therapy Refractory Lung and Biliary Tract Tumors
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