Clinical trial · Interventional
CAP7.1 for the Treatment of Advanced Stage, Therapy Refractory Lung and Biliary Tract Tumors
Phase II Trial of CAP7.1 in Adult Patients With Refractory Malignancies: Small Cell Lung Carcinoma, Non-Small Cell Lung Carcinoma, Biliary Carcinoma (PIITCAP)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated to be redesigned for a trial according to EMA proposal.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Endstage Solid Carcinomas in Adults | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAP7.1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Small cell lung cancer
- description
- Histologically- or cytologically-confirmed, limited and extensive SCLC disease with progression after first or second line treatment
- interventionNames
- Drug: CAP7.1
- type
- EXPERIMENTAL
- label
- Non small cell lung cancer
- description
- Histologically- or cytologically-confirmed diagnosis of NSCLC with Stage IIIB or IV after failure of at least two lines of therapy
- interventionNames
- Drug: CAP7.1
- type
- EXPERIMENTAL
- label
- biliary tract cancer
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKeilholz 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. PMID 28531881