Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Darinaparsin · 2 trials · 4 indications
a primary outcome measure is to determine the toxicity profile of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle
a primary outcome measure is to determine the maximum tolerated dose of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle
a primary outcome measure is to determine the preliminary activity/efficacy of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle
a primary outcome measure is to determine the pharmacokinetic profile of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle
| Arm | Type | Description |
|---|---|---|
| Single Arm | EXPERIMENTAL | - |
| oral darinaparsin | EXPERIMENTAL | open label, single arm, dose escalation |
| Name | Type | Description |
|---|---|---|
| Darinaparsin | DRUG | 300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months. |
Inclusion Criteria 1. Hodgkin's or non-Hodgkin's Lymphoma. 2. ≥ 1 prior therapy and currently requiring therapy. 3. Evaluable disease (defined by disease-specific criteria listed in Appendix 1) 4. ≥ 18 years of age. 5. ECOG performance score ≤ 2 (see Appendix 2). 6. Life-expectancy ≥ 2 months. 7. W...