Phase 1B in NSCLC

Phase 1B Trial in Advanced NSCLC – Completed Study

The Phase 1b/2 trial (NCT00630110) evaluated patients with advanced non-small cell lung cancer (NSCLC) to assess the recommended Phase 2 dose (RP2D) of Plinabulin combined with Docetaxel.

Study Status

Completed.

Study Design

The completed Phase 1b/2 study was an open label, dose escalation trial of Plinabulin in combination with docetaxel.

In Stage 1 in a dose-escalation treatment regimen, 13 patients received 75 mg/m2 of Docetaxel on day 1 and Plinabulin on days 1 and 8 intravenously in 21 day cycles. Plinabulin was escalated from the biologically effective dose (BED) of 13.5 mg/m2 to the standard single agent dose of 30 mg/m2 using a “3+3” design.

Key Findings

Results of the Phase 1b segment of the trial demonstrated a RP2D of 30mg/m2 of Plinabulin with 75 mg/m2 docetaxel and that the combination of full doses of Plinabulin and Docetaxel is tolerable with adverse events consistent with those of both agents alone. There was no drug and drug interaction between Plinabulin and docetaxel. In addition, results showed encouraging anti-tumor activity, supporting further development of this combination.

Patient Population

Patients with advanced non-small cell lung cancer (NSCLC).

More Information

Results of this trial were published as follows:

M. Millward et al., Phase 1 study of the novel vascular disrupting agent Plinabulin (NPI-2358) and docetaxel, Investigational New Drugs, Vol. 30, pp. 1065–1073, 2012.