Clinical trial NCT02094560: CAP7.1 for the Treatment of Advanced Stage, Therapy Refractory Lung and Biliary Tract Tumors
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Endstage Solid Carcinomas in Adults
Keywords: therapy refractory
endstage
solid tumours
Lead sponsor: CellAct Pharma GmbH
Sponsor class: INDUSTRY
Collaborators: name: Mundipharma-EDO GmbH
First posted: 2014-03-24
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to disease progression
timeFrame: 18 month
Secondary outcomes:
measure: 1. Percentage of Subjects With Objective Response [i.e., complete response (CR) + partial response (PR)] According to RECIST1.1
timeFrame: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
measure: Time to Treatment Failure
timeFrame: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
measure: Progression-Free Survival (PFS)
timeFrame: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
measure: Disease-free survival
timeFrame: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
measure: Overall Survival (OS)
timeFrame: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
measure: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
measure: Maximum Observed Drug Concentration (Cmax) of CAP7.1 in Plasma
timeFrame: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
measure: Time to Reach Maximum Drug Concentration (tmax) of CAP7.1 in Plasma
timeFrame: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
measure: Half-life Associated With the Terminal Slope (t1/2) of CAP7.1 in Plasma
timeFrame: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
measure: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of CAP7.1 in Plasma
timeFrame: Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite, University Hospital
Study officials:
References:
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.