A study of ceralasertib (AZD6738) as monotherapy and in combination with other anticancer agents in patients with advanced solid malignancies Module 5 (ceralasertib in combination with AZD5305) (ANGEL)

Brief description of study

Penn Gynecologic Oncology is participating in Module 5 for ovarian cancer patients.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Advanced Malignancies
Age: Between 18 Years - 99 Years
Gender: Female

Core Inclusion Criteria for All Parts of the Study

1 Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses; including access to all archival tumour tissue (diagnostic and/or most recent samples).

2 Aged at least 18 years.

3 Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration over the previous 2 weeks and an estimated life expectancy of greater than 12 weeks.

4 Females must be using adequate contraceptive measures (Section 2.3), must not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:

- Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.

- Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.

- Amenorrhoeic for 12 months and serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and plasma oestradiol levels in the postmenopausal range for the institution.

5 For the duration of the study and for 1 week after the last study drug administration, sexually active male patients must be willing to use barrier contraception i.e., condoms with all sexual partners. Where the sexual partner is a ‘woman of child-bearing potential’ who is not using effective contraception, men must use a condom (with spermicide) during the study and for 6 months after the last dose of a study drug.

6 Ability to swallow and retain oral medication.

Host Genetics Research Study (optional)

For inclusion in the optional genetics research study patients must fulfil the following criteria:

1 Provision of optional genetics research informed consent

If a patient declines to participate in any optional component of the study, there will be no penalty or loss of benefit to the patient and will not be excluded from any other aspect of the main study.

Updated on 10 Apr 2024. Study ID: 854738

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