A Phase 1 Study Evaluating AMG 232 in Advanced Solid Tumors or Multiple Myeloma

• Status: Completed
• Trial end date: 2017-09-25
• Target enrollment: 0
• Participant gender: All

Summary

First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Kartos Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Men or women > 18 years old

• Pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or which no standard therapy is available, or the subject refuses standard therapy or multiple myeloma

• Willing to undergo pre-dose core needle tumor biopsies or bone marrow aspirate for subjects with multiple myeloma.

• Ability to take oral medications and willing to record daily adherance to investigational product

• Adequate hematological, renal, hepatic, and coagulation laboratory assessments

Exclusion Criteria:

• Active brain metastases

• For solid tumor-History or presence of hematological malignancies unless curatively treated with no evidence of disease for greater than or equal to 5 years

• Active infection requiring intravenous (IV) antibiotics

• Anti-tumor therapy

• Therapeutic or palliative radiation therapy within 30 days of starting treatment

• Currently enrolled in another investigational device or drug study