Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents (NCT02264678)
A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ceralasertib in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies.
๐ฉบ Plain-English Summary (8th-Grade Level)
This is a modular, phase I/ phase 1 b, open-label, multicentre study of ceralasertib administered orally in combination with cytotoxic chemotherapy regimens and/or novel anti-cancer agents, to patients with advanced malignancies. The study design allows an investigation of optimal combination dose of ceralasertib with other anti-cancer treatments, with intensive safety monitoring to ensure the safety of the patients. The initial combination to be investigated is ceralasertib with carboplatin. The second combination to be investigated is ceralasertib with Olaparib. The third combination to be investigated is ceralasertib with durvalumab. The fourth module will investigate the effect of food on ceralasertib absorption and the effect of ceralasertib on ECG parameter. The fifth module to be investigated is ceralasertib with AZD5305.
Who can join: Review the eligibility criteria below.
Location: Research Site โ Duarte, California
Age range: 18 Years to 130 Years
๐งช Interventions in This Study
- Administration of ceralasertib (DRUG)
- Administration of ceralasertib in combination with olaparib (DRUG)
- Administation of ceralasertib in combination with durvalumab (DRUG)
- Administration of ceralasertib monotherapy (DRUG)
- Administration of ceralasertib and olaparib (DRUG)
- Administration of ceralasertib and durvalumab (DRUG)
- Administration of ceralasertib in combination with AZD5305 (DRUG)
- Administration of ceralasertib in combination with carboplatin (DRUG)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (28 Sites)
Showing the first 25 of 28 sites.
- Research Site โ Duarte, California
- Research Site โ Irvine, California
- Research Site โ Los Angeles, California
- Research Site โ Los Angeles, California
- Research Site โ Newport Beach, California
- Research Site โ Boston, Massachusetts
- Research Site โ New York, New York
- Research Site โ Philadelphia, Pennsylvania
- Research Site โ Bordeaux,
- Research Site โ Lyon,
- Research Site โ Saint-Herblain,
- Research Site โ Villejuif,
- Research Site โ Goyang-si,
- Research Site โ Seongnam-si,
- Research Site โ Seoul,
- Research Site โ Seoul,
- Research Site โ Seoul,
- Research Site โ Bristol,
- Research Site โ Cambridge,
- Research Site โ Coventry,
- Research Site โ London,
- Research Site โ London,
- Research Site โ London,
- Research Site โ London,
- Research Site โ Manchester,
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.