An Open-label Phase I/II Study of KX2-391 in Combination With Paclitaxel in Patients With Advanced Solid Tumors

NCT01764087 Phase 1/Phase 2 UNKNOWN

The primary objective of this study is to determine the maximum tolerated dose (MTD) of KX2-391 in Combination with paclitaxel in Phase I, and to evaluate the efficacy of KX2-391 in combination with paclitaxel in patients who are diagnosed as gastric and breast cancer, respectively in Phase II.

Details

Lead sponsor	Hanmi Pharmaceutical Company Limited
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	60
Start date	2012-12
Completion	2016-05

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific
• Gastric Cancer
• Breast Cancer

Interventions

• KX2-391 and Paclitaxel

Primary outcomes

• Dose-limiting Toxicities (DLTs) in Phase I Portion — From start of the treatment to end of cycle 1, which are 4 weeks
  Maximum tolerated dose (MTD) of KX2-391 in combination with weekly paclitaxel as determined by number of participants With DLTs related to KX2-391 in combination with weekly paclitaxel
• Tumor Overall Response Rates (ORRs) in Phase II Portion — In every 2 cycles up to end of the treatment, an expected average of 16 weeks
  The efficacy (overall response rate; ORR; complete response (CR) + partial response (PR)) of KX2-391 in combination with weekly paclitaxel at the MTD established during the phase I portion of this trial based on Response Evaluation Criteria in Solid Tumor (RECIST) 1.1

Countries

South Korea