NCT02094560

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2017

Completed
Last Updated

September 5, 2018

Status Verified

August 1, 2018

Enrollment Period

3.8 years

First QC Date

March 18, 2014

Last Update Submit

August 31, 2018

Conditions

Advanced Endstage Solid Carcinomas in Adults

Keywords

therapy refractoryendstagesolid tumours

Outcome Measures

Primary Outcomes (1)

  • Time to disease progression

    Assessment of antitumor activity based on RECIST 1.1 criteria (complete response; partial response; stable disease)

    18 month

Secondary Outcomes (10)

  • 1. Percentage of Subjects With Objective Response [i.e., complete response (CR) + partial response (PR)] According to RECIST1.1

    Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)

  • Time to Treatment Failure

    Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)

  • Progression-Free Survival (PFS)

    Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)

  • Disease-free survival

    Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)

  • Overall Survival (OS)

    Start of study treatment until 26 days post-last study treatment (approximately 4 years and 2 months)

  • +5 more secondary outcomes

Study Arms (3)

Small cell lung cancer

EXPERIMENTAL

Histologically- or cytologically-confirmed, limited and extensive SCLC disease with progression after first or second line treatment

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

Drug: CAP7.1

biliary tract cancer

EXPERIMENTAL

Histologically or cytologically confirmed diagnosis of biliary tract cancer progress after first line therapy

Drug: CAP7.1

Interventions

CAP7.1DRUG

CAP7.1 is a prodrug of Etoposide released after via specific carboxyesterase

Non small cell lung cancerSmall cell lung cancerbiliary tract cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite, University Hospital

Berlin, 10117, Germany

Location

Related Publications (1)

  • 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.

    PMID: 28531881DERIVED

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 24, 2014

Study Start

November 8, 2011

Primary Completion

September 8, 2015

Study Completion

April 10, 2017

Last Updated

September 5, 2018

Record last verified: 2018-08

Locations

DE(1)