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Title A Phase 1/2 Open-label Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial

IRB APGD2Y15

CC 15-1540

Hospital Main Campus

Phase Phase 1, Phase 2

Disease Solid Tumors

Drug ASP2215

Description

The objective of the study is to provide access to continued treatment for subjects who participated in other previous Astellas sponsored ASP2215 (single agent) trials and for whom the Investigator feels the subject may benefit from continued treatment.

Inclusion Criteria

1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations [e.g., Health Insurance Portability and Accountability Act (HIPAA) Authorization for US sites] must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
2. Subject must currently be participating in an Astellas sponsored ASP2215 trial, receiving ASP2215 and is able to enroll into this rollover study without interruption of study drug, or with no more than 2 weeks interruption in study drug.
3. Subject must be deriving benefit from continued treatment as determined by the Investigator.
4. Female subject must either:
   • Be of non-childbearing potential:
     • post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
     • documented surgically sterile (at least one 1 month prior to Screening)
   • Or, if of childbearing potential,
     • Agree not to try to become pregnant during the study and for 45 days after the final study drug administration
     • And have a negative urine pregnancy test at Day 1
     • And, if heterosexually active, agree to consistently use two forms of highly effective birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 45 days after the final study drug administration.
   • Highly effective forms of birth control include:
     • Consistent and correct usage of established oral contraception.
     • Established intrauterine device (IUD) or intrauterine system (IUS).
     • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository (for regions where spermicidal foam/gel/film/cream/suppository is not available e.g., Japan).
     • Calendar-based contraceptive methods (Knaus-Ogino or rhythm method applicable to subjects enrolled at sites in Japan.
5. Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 45 days after the final study drug administration.
6. Female subject must not donate ova starting at Screening and throughout the study period, and for 45 days after the final study drug administration.
7. Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 105 days after the final study drug administration.
8. Male subject must not donate sperm starting at Screening and throughout the study period and, for 105 days after the final study drug administration.
9. Subject agrees not to participate in another interventional study while on treatment.

Exclusion Criteria

1. Subject requires treatment with concomitant drugs that are strong inducers of CYP3A4 or strong inhibitors or inducers of P-gp or substrates of MATE1 with the exception of drugs that are considered absolutely essential for the care of the subject.
2. Subject requires treatment with concomitant drugs that target serotonin 5HT1R or 5HT2BR or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.