Advanced Endstage Solid Carcinomas in AdultsPhase 2CAP7-1NCT02094560
CAP7.1 for the Treatment of Advanced Stage, Therapy Refractory Lung and Biliary Tract Tumors
A Phase 2 study testing CAP7.1 in people with Advanced Endstage Solid Carcinomas in Adults, run by CellAct Pharma GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Endstage Solid Carcinomas in Adults
- What is being tested?
- CAP7.1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 8 Nov 2011to 10 Apr 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Being tested
- CAP7.1
- Keywords
- therapy refractory, endstage, solid tumours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAP7.1Drug
CAP7.1 is a prodrug of Etoposide released after via specific carboxyesterase
| Study group | Role | What they receive |
|---|---|---|
| Small cell lung cancer | Experimental | Histologically- or cytologically-confirmed, limited and extensive SCLC disease with progression after first or second line treatment Receives: Drug: CAP7.1 |
| Non small cell lung cancer | Experimental | Histologically- or cytologically-confirmed diagnosis of NSCLC with Stage IIIB or IV after failure of at least two lines of therapy Receives: Drug: CAP7.1 |
| biliary tract cancer | Experimental | Histologically or cytologically confirmed diagnosis of biliary tract cancer progress after first line therapy Receives: Drug: CAP7.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression
Assessment of antitumor activity based on RECIST 1.1 criteria (complete response; partial response; stable disease)
Measured: 18 month
Secondary outcomes (10)
1. Percentage of Subjects With Objective Response [i.e., complete response (CR) + partial response (PR)] According to RECIST1.1
Measured: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Time to Treatment Failure
Measured: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Progression-Free Survival (PFS)
Measured: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Disease-free survival
Measured: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Overall Survival (OS)
Measured: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Measured: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Maximum Observed Drug Concentration (Cmax) of CAP7.1 in Plasma
Measured: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Time to Reach Maximum Drug Concentration (tmax) of CAP7.1 in Plasma
Measured: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Half-life Associated With the Terminal Slope (t1/2) of CAP7.1 in Plasma
Measured: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of CAP7.1 in Plasma
Measured: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study start8 Nov 2011
- Primary completion8 Sep 2015
- Study completion10 Apr 2017
Why it stopped: The study was terminated to be redesigned for a trial according to EMA proposal.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Endstage Solid Carcinomas in AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- CellAct Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mundipharma-EDO GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094560
- Sponsor's protocol ID
- CPN710102
- Other IDs
- 2012-002378-30
- Acronym
- CAP7-1
- Status last verified
- Aug 2018
- First submitted
- 18 Mar 2014
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28531881
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02094560
- Acronym / sponsor ID
- CAP7-1 / CPN710102
- Keywords
- therapy refractory, endstage, solid tumours
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated to be redesigned for a trial according to EMA proposal.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- CellAct Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Mundipharma-EDO GmbH
- Study start
- 8 Nov 2011 (actual)
- Primary completion
- 8 Sep 2015 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Small cell lung cancer | Experimental | Drug: CAP7.1Histologically- or cytologically-confirmed, limited and extensive SCLC disease with progression after first or second line treatment |
| Non small cell lung cancer | Experimental | Drug: CAP7.1Histologically- or cytologically-confirmed diagnosis of NSCLC with Stage IIIB or IV after failure of at least two lines of therapy |
| biliary tract cancer | Experimental | Drug: CAP7.1Histologically or cytologically confirmed diagnosis of biliary tract cancer progress after first line therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAP7.1CAP7.1 is a prodrug of Etoposide released after via specific carboxyesterase | Drug | Non small cell lung cancer, Small cell lung cancer, biliary tract cancer |
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)
10 secondary outcomes
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)
Time to Treatment Failure
Time frame: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Progression-Free Survival (PFS)
Time frame: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Disease-free survival
Time frame: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Overall Survival (OS)
Time frame: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
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)
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)
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)
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)
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)
Results and safety
The study was stopped early (reason given: The study was terminated to be redesigned for a trial according to EMA proposal.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Derived from this study: PubMed 28531881Keilholz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAP7.1 in people with Advanced Endstage Solid Carcinomas in Adults, run by CellAct Pharma GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated to be redesigned for a trial according to EMA proposal.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to disease progression (time frame: 18 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02094560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.