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Phase II study of safety and efficacy of motesanib in patients with progressive or symptomatic, advanced or metastatic medullary thyroid cancer
Journal of Clinical Oncology, 08/10/09

Schlumberger MJ et al. – Phase II study demonstrates that a significant proportion of medullary thyroid cancer (MTC) patients (81%) achieved stable disease while receiving motesanib (inhibitor of VEGFRs, PDGFRs, and Kit), however the objective response rate was low.

Methods

An investigation of the efficacy and tolerability of motesanib, in advanced MTC
Pts received motesanib 125 mg/d orally for upto 48 wks or until unacceptable toxicity or disease progression
Primary end point: objective response by independent review
Other end points: duration of response, PFS, safety, pharmacokinetics, and changes in tumor markers

Results

2% pts achieved objective response; their duration of response was 32 wks (censored) and 21 wks (disease progressed):
- 81% pts had stable disease (48% had durable stable disease ≥24 wks)
- 8% had disease progression as best response
- 9% were not evaluated
- 76% experienced a decrease from baseline in target lesion measurement
Median PFS was 48 wks
Among pts with tumor marker analysis: 83% and 75% had decreased serum calcitonin and carcinoembryonic antigen during treatment, respectively, vs baseline
Most common treatment-related AEs were diarrhea, fatigue, hypothyroidism, hypertension, and anorexia
In pharmacokinetic analyses, motesanib trough concns were lower vs differentiated thyroid cancer pts

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