A Study To Determine The Safety, Tolerability, Pharmacokinetics And Recommended Phase 2 Dose Of CCX559 In patients With Solid Tumors

Phase 1

• Conditions: eoplastic Disorder - Solid Tumors; Neoplastic Disorder - Solid Tumors; Cancer - Any cancer

• Registration Number: ACTRN12621001342808
• Lead Sponsor: ChemoCentryx, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-07
• Study Completion: 2023-06-07
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Aged at least 18 years (inclusive at the time of informed consent);
2. ECOG Performance Status of 0 to 1
3. Life expectancy of greater than or equal to 12 weeks.
4. Must not have had a live vaccine administration within 28 days prior to the first dose of study drug.
5.Must have the ability to swallow and retain oral medications
6. Histologically or cytologically confirmed solid tumor that is refractory, locally advanced, or metastatic and for which standard curative or palliative measures do not exist or are no longer effective.

Exclusion Criteria

1. Receiving medications that are strong inhibitors or inducers of CYP3A4
2. Receiving drugs that prolong the QTc interval
3. Received anticancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, within 28 days (or 5 half-lives for biologic/non-cytotoxic agents, whichever is shorter), prior to the first dose of the study drug. Palliative radiotherapy given within 28 days prior to the first dose of study drug may be approved on a case-by-case basis in discussion with the Sponsor.
4. Has a history of clinically significant allergic reactions attributed to compounds of similar
chemical composition to CCX559 or other agents used in study.
5. Has an uncontrolled intercurrent illness or clinically significant uncontrolled condition(s);
active bacterial, fungal, or viral infections requiring systemic therapy
6. History of primary immunodeficiency, bone marrow transplantation or solid organ
transplantation

Study & Design

• Study Type: Interventional
• Study Design: Not specified