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CAP7.1 in Refractory Malignancies (NSCLC, SCLC, Biliary Carcinoma)
NCT02094560Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2011
- Primary completion
- Sep 2015
- Countries
- 1
- Sponsor
- CellAct Pharma GmbH
- Modality
- Small Molecules
- Drugs
- etoposide toniribate
- Conditions
- Small Cell Lung Cancer (SCLC)non-small cell lung carcinoma (NSCLC)biliary tract cancer (BTC)
01
Overview
Phase 2, randomised, open-label trial of etoposide toniribate in Small Cell Lung Cancer (SCLC), non-small cell lung carcinoma (NSCLC) and biliary tract cancer (BTC) (6 arms), sponsored by CellAct Pharma GmbH. Primary endpoint: Time to disease progression at 18 months. Started Nov 2011; status: terminated.
02
Design
6 arms- Study design
- RandomizedOpen-label
SCLC - CAP7.1
CAP7.1 treatment for SCLC
SCLC - BSC
Best Supportive Care for SCLC
NSCLC - CAP7.1
CAP7.1 treatment for NSCLC
NSCLC - BSC
Best Supportive Care for NSCLC
Biliary - CAP7.1
CAP7.1 treatment for Biliary Tract Cancer
Biliary - BSC
Best Supportive Care for Biliary Tract Cancer
03
Who it enrols
Adult patients with histologically or cytologically confirmed advanced NSCLC, SCLC, or biliary tract cancer who have progressed after at least one line of chemotherapy (two for NSCLC). Patients must have recovered from prior chemotherapy toxicity.
04
Endpoints
Primary
Time to disease progression
Secondary
Objective Response Rate
Time to Treatment Failure
Progression-Free Survival
Disease-free survival
Overall Survival
Treatment Emergent Adverse Events
Maximum Observed Drug Concentration
Time to Reach Maximum Drug Concentration
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