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Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy in adult patients with advanced solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A | Experimental | Carboplatin plus PF-01367338 |
|
| ARM A EXPANSION | Experimental | Carboplatin plus PF-01367338 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-01367338 | Drug | Increasing doses of single lead-in (Day -10) intravenous and daily oral PF-01367338 administered from Day 1 to Day 14 every 3-week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs) | Dose-limiting toxicities and adverse events | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens | Time to attain maximum plasma concentration [Tmax] | 18 months |
| Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Churchill Hospital | Oxford | Oxfordshire | OX3 7LJ | United Kingdom | ||
| Royal Marsden Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35397664 | Derived | Green ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10. | |
| 28222073 | Derived |
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| Carboplatin | Drug | Standard doses of intravenous Carboplatin administered every 3 weeks |
|
| PF-01367338 | Drug | RP2 doses of oral PF-01367338 administered daily from Day 1 to Day 14 every 3-week cycle |
|
| Carboplatin | Drug | Standard doses of intravenous Carboplatin administered every 3 weeks |
|
maximum plasma concentration (CMax) |
| 18 months |
| Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens | area under plasma concentration curve (AUC) | 18 months |
| Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens | apparent terminal half-life (t1/2) | 18 months |
| Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens | rucaparib oral bioavailability | 18 months |
| PARP activity and expression in peripheral blood lymphocytes (PBL) | % PARP activity | 18 months |
| Determination of food effect on oral PF-01367338 pharmacokinetics | fasted and fed parameters area under the plasma concentration-time curve from time 0 to the last recorded observation [AUClast] | 18 month |
| Determination of food effect on oral PF-01367338 pharmacokinetics | fasted and fed maximum plasma concentration (Cmax) | 18 month |
| Determination of effect of PF-013567338 administration on QTc prolongation test | electrocardiogram[ecg], QTcF, QTcB | 18 months |
| Sutton |
| Surrey |
| SM2 5PT |
| United Kingdom |
| Belfast City Hospital | Belfast | BT9 7AB | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| Kings College London | London | SE1 9RT | United Kingdom |
| Sir Bobby Robson Cancer Trials Research Centre | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Wilson RH, Evans TJ, Middleton MR, Molife LR, Spicer J, Dieras V, Roxburgh P, Giordano H, Jaw-Tsai S, Goble S, Plummer R. A phase I study of intravenous and oral rucaparib in combination with chemotherapy in patients with advanced solid tumours. Br J Cancer. 2017 Mar 28;116(7):884-892. doi: 10.1038/bjc.2017.36. Epub 2017 Feb 21. |
| ID | Term |
|---|---|
| C531549 | rucaparib |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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