Phase 1

Phase 1 Trial in Advanced Solid Tumors or Lymphoma – Completed Study

This part of the study concerning advanced solid tumors or lymphoma, evaluated Plinabulin in a Phase 1 trial (NCT00322608) in patients with refractory solid tumors or lymphoma with the goal of identifying the recommended Phase 2 dose (RP2D) as well as assessing the drug’s safety, pharmacokinetics (PK) and biologic activity.

Study Status

Completed.

Study Design

The completed Phase 1a study was an open label, dose escalation study of Plinabulin monotherapy, given to patients through infusion. A total of 38 patients were enrolled who were also dosed with Plinabulin.

Phase 1a evaluated Plinabulin at select doses (2, 4, 6, 9, 13.5, 20, 30 mg/m2) every week for three weeks in 4-week cycles to establish the RP2D.

Key Findings

The study determined the RP2D as 30 mg/m2. At RP2D, Plinabulin demonstrated a favorable safety profile, while eliciting biological effects as evidenced by decreases in tumor blood flow, tumor pain, and other mechanistically relevant adverse events. The study confirmed proof of mechanism that Plinabulin demonstrates dose-dependent decrease of tumor blood flow.

Patient Population

Patients with advanced solid tumor malignancies or lymphoma.

More Information

Results of this trial were published as follows:

M. M. Mita et al., Phase 1 first-in-human trial of the vascular disrupting agent Plinabulin (NPI-2358) in patients with solid tumors or lymphomas, Clinical Cancer Research, Vol. 16, pp. 5892-5899, 2010.