Clinical Trials

Click on each heading to learn about the clinical trial phases.

Preclinical

Assay/Test Method Description Results
MTT Cytotoxic assay Complete modulation
XTT Cytotoxic assay Complete modulation
Flow Cytometery Flourescence  
  Inhibition/efflux  
     -Rhodamine 123 Complete Inhibition
     -Calcein Complete Inhibition
      -In Vivo CDX 56 Complete Inhibition

Phase I Trials

Phase I in patients failing first line therapy using concurrent Doxorubicin at several dosage levels designed to determine maximum tolerable dose in combination with fixed dose of Doxorubicin and pharmacokinetic interaction.

Phase I with Paclitaxel in patients who had failed first line therapy, including Paclitaxel. Two additional patients entered on separate arm to study pharmacokinetic interaction. 

Phase I study in combination with Paclitaxel and Carboplatin in unresectable NSCLC.

Phase I study in combination with Paclitaxel and Doxorubicin in advanced unresectable breast cancer.

Phase II Trials

Phase II study with high dose Cytosine Arabinoside and Daunorubicin in multiple relapsed or refractory AML

Phase II with Paclitaxel in various advanced relapsed cancers including GI, multiple myeloma, breast, SCLC,NSCLC,ovarian,prostate, cervical and head & neck.

Phase II Pharamcodynamic study of CBT-1® and Paclitaxel evaluating PGP inhibition in tumor and normal tissue conducted in collaboration with the NCI.

Phase III Trials

Placebo controlled randomized study of CBT-1® Paclitaxel and Carboplatin in NSCLC.