GP Pharm SA

To evaluate the overall survival (OS) benefit of rubitidin alone or in combination with rubitidin and irinotecan compared with topotecan in patients with relapsed SCLC who had failed first-line etoposide and platinum chemotherapy.

To evaluate the safety and tolerability of PM01183 monotherapy in Chinese patients with advanced solid tumors, and to determine the dose-limiting toxicity (DLT) and recommended dose (RD) of PM01183 monotherapy. To evaluate the preliminary clinical efficacy of PM01183 monotherapy at the recommended dose in second-line patients with small cell lung cancer. To evaluate the pharmacokinetic (PK) characteristics of PM01183 monotherapy in Chinese patients with advanced solid tumors.

Primary Objective To compare the testosterone suppression effects of the novel leuprolide acetate extended-release microspheres 3.75 mg and leuprolide acetate extended-release microspheres 3.75 mg for injection in healthy subjects by pharmacodynamic parameters, and to compare the ratio of serum testosterone reaching castrate levels between the two groups of subjects at the end of 4 weeks. Secondary Objective To evaluate the safety and tolerability of leuprolide acetate extended-release microspheres 3.75 mg; to evaluate the blood pharmacokinetic parameters of leuprolide acetate extended-release microspheres 3.75 mg.