Table 2.
Drug used | Phase | Pts No. (=) | Study population | Safety | Best response | Reference or Trial number |
---|---|---|---|---|---|---|
Combination of Mapatumumab with | ||||||
Paclitaxel and carboplatin | I | 27 | Advanced solid tumours | Safe with paclitaxel and cisplatin up to 20 mg·kg−1 with no occurrence of dose limiting toxicity | Partial response (5), stable disease (12) | 109 |
Ib | 28 | Advanced solid tumours | Pharmacokinetic profile of HGS-ETR1 not affected by paclitaxel and carboplatin | Partial response (6), stable disease103 | 109 | |
Paclitaxel and carboplatin | II R | 111 | First-line advanced non-small cell lung carcinoma | The results do not support further evaluation in combination with paclitaxel, carboplatin in patients with advanced non-small cell lung carcinoma | Similar to paclitaxel, carboplatin alone | 110 NCT00583830 |
Gemcitabine and cisplatin | Ib | 49 | Advanced solid tumours | Safe with gemcitabine and cisplatin at doses up to 30 mg·kg−1 | Partial response (12), stable disease111 | 112 |
Cisplatin and radiotherapy | Ib/II | 42* | Objective is 42 Patient with first-line advanced cervical cancer | Recruiting | Not reported | NCT01088347 |
Sorafenib | Ib | 19 | Advanced hepatocellular carcinoma and chronic viral hepatitis | Safe with sorafenib at doses up to 30 mg·kg−1 | Partial response (2), stable disease (4) | NCT00712855 |
II | 100* | 101 patients were randomized; 51 in the placebo–sorafenib arm and 50 patients in the mapatumumab–sorafenib arm | Overall, the frequency of AEs, serious AEs (SAEs), and severe AEs was comparable between the two treatment arms. Only increased lipase was considered related to mapatumumab by investigators. | NO clinical or statistical significance were noted between the 2 arms in terms of median PFS or median OS | NCT01258608 | |
Bortezomib | II R | 104 | Relapsed/Refractory multiple myeloma | No adverse effects but no benefit | Similar to bortezomib alone | NCT00315757 |
Mapatumumab or TRM1 or HGS-ETR1 alone | ||||||
Ia | 49 | Advanced solid tumours | Safe and well tolerated up to 20 mg·kg−1 i.v. – half-life 18–21 days |
Stable disease (19) | 113 | |
Ia | 41 | Advanced solid tumours | Peak plasmatic concentrations compatible with preclinical studies | Stable disease (12) | 114 | |
Ib/ II | 40 | Relapsed/Refractory non-Hodgkin lymphoma | Three clinical responses out of 15 follicular lymphoma patients. | Complete response (2), partial response (1), stable disease (12) | 115 NCT00094848 | |
II | 32 | Relapsed/Refractory stage IIIb/IV or recurrent non-small cell lung carcinoma | No adverse effects, but no clinical activity demonstrated | Stable disease (9) | 116 NCT00092924 | |
II | 38 | Refractory colorectal cancer | - | Stable disease (12) | 117 |
*Estimation/expected. Clinical trials number listed in this table can be found at: http://www.clinicaltrials.gov