Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Calaspargase Pegol-mknl · 1 trial · 7 indications
Defined as any treatment-related grade \>= 3 non-hematological or hematological adverse events. The incidence of DLT at each dose level will be summarized using the proportion and exact binomial confidence interval. Dose-limiting toxicities will specifically be reported for the DLT evaluation period using the maximum tolerated dose (MTD)-evaluable population. The MTD will be identified using isotonic regression.
| Arm | Type | Description |
|---|---|---|
| Treatment (calaspargase pegol-mknl, cobimetinib) | EXPERIMENTAL | Patients receive calaspargase pegol-mknl IV over 1 hour on day 1 and cobimetinib PO QD on days 1-14. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo a biopsy 14 days prior to starting therapybefore cycle 1, day 1 and again on day 14 of cycle 2, day 15 per the investigator's discretion, with an additional optional biopsy at the time of disease progression. |
| Name | Type | Description |
|---|---|---|
| Biopsy | PROCEDURE | Undergo biopsy |
| Calaspargase Pegol-mknl | DRUG | Given IV |
| Cobimetinib | DRUG | Given PO |
Inclusion Criteria: * Participant must provide written informed consent before any study-specific procedures or interventions are performed * Participants are \>= 18 years old at the time of informed consent. Both men and women of all races and ethnic groups will be included * Eastern Cooperative O...