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Platinum-resistant Ovarian CancerPhase 1CREATIVENCT04678102

Chk2 Inhibitor for Recurrent EpitheliAl periToneal, fallopIan or oVarian cancEr (CREATIVE Phase IA Trial)

A Phase 1 study testing PHI-101 administration in people with Platinum-resistant Ovarian Cancer and Platinum-refractory Ovarian Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to assess the safety and tolerability of PHI-101 in patients with platinum-resistance/refractory ovarian, fallopian tubal, and primary peritoneal cancer. This study also evaluates the pharmacokinetics of PHI-101 and efficacy of PHI-101 during treating platinum-resistance/refractory ovarian, fallopian… Read more about this study

Who is it for?
Ages 19 years and older, women only
What is being tested?
PHI-101 administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSouth Korea
Study dates
17 Dec 2020to 31 Dec 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females aged ≥ 19 years at the time of informed consent
  • Pregnancy (childbearing potential and planning a pregnancy) and breast-feeding status ① Women of non-childbearing potential, women who are not pregnant or breast-feeding, or women who are not planning a pregnancy during the study
  • ② Women of childbearing potential (Section 10.3.2.7.1) who have a confirmed negative pregnancy test at screening and immediately before administration of PHI-101 and agree to use an effective contraceptive method(s) (Section 10.3.2.7.2) required in this protocol for 6 months (24 weeks) from the last dose of PHI-101
  • Indication
  • ① Histologically or cytologically confirmed ovarian cancer, fallopian tube carcinoma, or primary peritoneal cancer
  • ② Epithelial malignant tumors diagnosed through local histopathological findings [WHO Histological Classification, 2014]
Show all 18Show fewer
  • : except LGSC, mucinous carcinoma of the ovary, MMMT, and LAP, which are classified as LCOH, [NCCN Guideline version 2.2019].
  • LAP = low malignant potential (ovarian borderline epithelial tumor); LCOH = less common ovarian histopathology; LGSC = low-grade serous carcinoma; MMMT = malignant mixed Mullerian tumor (carcinosarcoma); NCCN Guideline = National Comprehensive Cancer Network Guideline; WHO Histological Classification = World Health Organization Histological Classification ③ Platinum-refractory cancer or platinum-resistance cancer†
  • Disease progression during platinum-based antineoplastic therapy, † Disease progression within 6 months (24 weeks) from completion of platinum-based antineoplastic therapy ④ Inoperable subjects who are refractory to, cannot receive, or refuse standard of care, which is currently known to be clinically beneficial ⑤ Subjects with ≥ 1 measurable lesion or nonmeasurable, but evaluable lesion that meets [RECIST version 1.1] RECIST = Response Evaluation Criteria in Solid Tumors
  • Expected life expectancy ≥ 12 weeks
  • [ECOG PS] ≤ 1 ECOG PS = Eastern Cooperative Oncology Group Performance Status
  • Subjects who have adequate hepatic, renal, and hematological function confirmed by the following laboratory tests (a re-test will be allowed during the screening period) ANC ≥ 1,500/mm3 (without administration of G-CSF within 2 weeks prior to baseline) Hb ≥ 10.0 g/dL (without transfusion within 2 weeks prior to baseline) Platelet count ≥ 75,000/mm3 (without transfusion within 2 weeks prior to baseline) Total bilirubin ≤ 1.5 x ULN AST and ALT ≤ 3.0 x ULN* (≤ 5 x ULN for patients with liver metastases or hepatocellular carcinoma) Serum creatinine (or CrCl) Serum creatinine ≤ 1.5 x ULN CrCl ≥ 60 mL/min (by Cockcroft-Gault equation)
  • Prior antineoplastic therapy and treatment ① Prior cytotoxic chemotherapy ≤ 5 times
  • ② Reversible side effects from prior antineoplastic therapy (operation, drug, radiation therapy, etc.) resolved to [CTCAE version 5.0] grade 1 or better
  • Subjects should not have had major surgery, antineoplastic therapy or experimental therapy, or direct radiation therapy on hematopoietic site within 4 weeks prior to baseline and should not be administered nitrosoureas or mitomycin-C within 6 weeks prior to baseline.
  • CTCAE = Common Terminology Criteria for Adverse Events
  • Subjects who voluntarily decided to participate and provided written consent after they were given sufficient explanation of this study
  • Subjects who are able to understand the study procedures and restrictions and willing to comply with them during the study

Who cannot join

  • 1) Subjects with known or suspected hypersensitivity or intolerance to the active ingredient or excipients of PHI-101 2) Subjects considered ineligible or unable to participate in this study according to the investigator's judgement for other reasons
  • Medical history or current medical condition and disease 3) Subjects with the following cardiac insufficiency or cardiovascular disease (but not limited to):
  • Evidence of myocardial ischemia or myocardial infarction within 12 weeks prior to baseline
  • [NYHA Functional Classification] ≥ II NYHA = New York Heart Association ③ LVEF < 50% confirmed by ECHO or MUGA scan LVEF = left ventricular ejection fraction; ECHO = echocardiography; MUGA = Multi-gated acquisition blood pool scintigraphy
  • Clinically significant cardiac arrhythmia that is uncontrolled by the adequate and optimal treatments
  • ⑤ Corrected QT (QTc) interval > 450 msec (for both men and women) or long QT syndrome (or family history)
Show all 23Show fewer
  • QT interval (QTcF) corrected using Fridericia's formula will be used. In case of bundle branch block, the Bazett's formula will be used (QTcB).
  • 4) Subjects with the following gastrointestinal diseases that affect intake or absorption of the drug (but not limited to):
  • Dysphagia
  • Paralysis of intestine and intestinal obstruction
  • ③ Gastrointestinal surgery that has a clinically significant effect on absorption of the drug: gastrotomy, small intestinal fistula, extensive small bowel resection, etc. (except for simple anastomosis)
  • ④ Autoimmune or inflammatory disease that involves the entire gastrointestinal system or small intestines: coeliac disease, intestinal graft versus host disease, Behcet's syndrome, scleroderma involving the gastrointestinal tract, Crohn's disease, ulcerative colitis, etc.
  • 5) Lung diseases (but not limited to):
  • New or progressive dyspnea, cough, and fever
  • ② Planned diagnosis of interstitial lung disease, or interstitial pneumonia
  • ③ Pulmonary fibrosis 6) Hematologic malignancy including lymphoma 7) Metastasis:
  • Central nervous system metastasis or brain metastasis ② Bone metastasis 8) Infectious disease (but not limited to):
  • Severe infectious disease requiring administration of antibiotics, antivirals, etc. that may affect the safety and efficacy assessments during the study
  • Active (overt) infectious disease that is uncontrolled by the adequate and optimal treatments as determined by the investigator 9) Known positive human immunodeficiency virus (HIV) 10) Active hepatitis B* or active hepatitis C†
  • HBsAg positive with HBV DNA detected † Anti-HCV positive with HCV RNA detected (qualitatively) 11) Unintentional weight loss > 10% within 12 weeks prior to informed consent 12) History of alcohol or other drug abuse within 1 year (52 weeks) prior to informed consent
  • Subjects who received, are receiving, or cannot stop the following therapy (medication/non-medication) 13) Subjects who need antineoplastic therapy other than the IP during the study participation (Point radiation to alleviate bronchial obstruction, skin lesion, etc. is allowed).
  • Surgery, radio(chemo)therapy, cytotoxic chemotherapy, targeted therapy (small molecule drug, monoclonal antibody), immuno-oncology drug (biological drug), hormone therapy, etc.
  • 14) Subjects who received (used) other investigational study product or device within 2 weeks or 5 half-lives prior to informed consent (whichever is shorter) 15) Subjects on drugs (nonprescription drug, herb, homeopathy, etc.) that have a significant effect on the assessment of kinetics (metabolism, excretion, etc. in the body) or efficacy and safety of the IP within 2 weeks prior to informed consent as determined by the investigator

Trial locations and contacts

1 site in 1 country.

Hee Seung Kim, MD contact

+82-2-2072-4863

bboddi0311@gmail.com

Soo Jin Park, MD contact

+82-2-2072-4863

soojin.mdpark@gmail.com

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul

    Soo jin Park, MD, 82-2-2072-0897, soojin.mdpark@gmail.com

    Hee Seung Kim, MD, 82-2-2072-4863, bboddi0311@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability, and Pharmacokinetics of PHI-101 in Patients With Platinum-Resistance/Refractory Ovarian Cancer

This study aims to assess the safety and tolerability of PHI-101 in patients with platinum-resistance/refractory ovarian, fallopian tubal, and primary peritoneal cancer. This study also evaluates the pharmacokinetics of PHI-101 and efficacy of PHI-101 during treating platinum-resistance/refractory ovarian, fallopian tubal, and primary peritoneal cancer.

PHI-101 is a CHK2 inhibitor that is a checkpoint kinase binding specifically to CHK2, rather than CHK1, and it inhibits the DDR system by inhibiting the ATM-CHK2 pathway, which is activated in response to DSBs. When a high-grade serous ovarian (HGSO) cancer cell line and various ovarian cancer cell lines (CAOV3, OVCAR3, SK-OV-03, and SW626) were treated with PHI-101 in a non-clinical study, the therapeutic effect of PHI-101 against ovarian cancer was demonstrated by a decrease in viability of ovarian cancer cells. In addition, a stronger growth inhibition effect was observed compared to that of treatment with olaparib or rucaparib alone, and a much stronger inhibition effect was observed when concomitantly used with paclitaxel, cisplatin, and topotecan. Based on the aforementioned results of the non-clinical studies, the potential of PHI-101 as a new treatment or concomitant cytotoxic chemotherapeutics for patients with ovarian cancer who are resistant to existing antineoplastic drugs was confirmed.

Read the detailed description

In this study, a maximum of 6 dose levels (cohorts) were planned for daily oral administration of PHI-101. Subjects who meet the inclusion/exclusion criteria of this study will be enrolled in each cohort and assessed for safety and tolerability after administering PHI-101 to determine the MTD. Subjects will be enrolled sequentially starting from the low-dose cohort, and DLT will be assessed for the first 28 days (Cycle 1) after the first dose of PHI-101. Before DLT is assessed in a specific cohort, enrolling a subsequent subject in the next higher dose cohort will not be allowed.

According to the accelerated 3+3 design, the accelerated dose escalation scheme, which assesses DLT in 1 subject in each cohort ('single subject cohort'), is applied until toxicity (ADRs) related to PHI-101 ≥ [CTCAE version 5.0] grade 2 occurs. If ADRs ≥ grade 2 do not occur in 1 subject, DLT can be assessed in one level higher cohort according to the SRC's recommendation. If an ADR ≥ grade 2 occurs in a specific cohort, the accelerated 3+3 design will be immediately switched to the standard 3+3 scheme, and 2 additional subjects will be enrolled in that cohort (1 subject + 2 additional subjects) to assess DLT during 1 cycle.

After switching to the standard 3+3 scheme, 3 to 6 subjects will be enrolled in each cohort. If no DLT is observed in the first 3 subjects, DLT can be assessed in one level higher cohort according to the SRC's recommendation. If DLT is observed in 1 out of 3 subjects (DLT: 1/3 subject), that cohort will be expanded to 6 subjects by enrolling 3 additional subjects. If 2 out of 3 to 6 subjects experience DLT (DLT: 2/3 to 6 subjects), this means that the MTD is exceeded. Thus, additional enrollment will be ended for that cohort. The one level lower cohort will expand to 6 subjects (If 6 subjects were already enrolled in that cohort, additional enrollment is unnecessary).

A subject not evaluable for DLT (withdrawal for reasons other than AEs or ADRs, or less than 20 out of 28 doses of PHI-101 were administered during Cycle 1) may be replaced by another subject according to the judgment of the investigator (decision/recommendation of the SRC, if necessary). If a subject in the single subject cohort is not evaluable for DLT, a substitute will be enrolled in the same cohort (1 subject + 1 additional subject) to assess DLT. If it is determined not to replace the subject not evaluable for DLT, the subject will be considered to have experienced DLT when the dose escalation is decided.

If DLT is observed in > 1 out of 6 subjects in a specific cohort (χ) and DLT is observed in ≤ 1 out of 6 subjects in the cohort (χ-1) that is one level lower than the specific cohort, the one level lower cohort (χ-1) will be considered as the MTD. The dose of PHI-101 will be escalated until an MTD is determined. If the MTD is not determined at the MPD, dose escalation will be ended at that dose (Addition of cohorts may be reviewed by and discussed with the SRC, if necessary, but reporting to the MFDS and the IRB and protocol amendment should occur first.) According to the schedule of activities (SOA), observation, questioning, examination, and tests to assess the safety and tolerability of PHI-101, PK sampling to assess PK, and tumor response assessment to explore efficacy will be performed.

After the EOT of PHI-101, the EOT visit will take place. Survival of subjects and initiation of new antineoplastic therapy will be periodically checked until the EOS. The follow-up will be performed for 1 year after the EOS to obtain such information.

Being tested
PHI-101 administration
Keywords
PHI-101, Chk2 inhibitor, antineoplastic, Platinum-resistant Ovarian Cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PHI-101 administrationDrug

    Also called PHI-101

    Escalated doses of PHI-101 will be administered to each cohort.

Study groups in NCT04678102
Study groupRoleWhat they receive
Cohort 1 (PHI-101 40mg/day)ExperimentalIn the starting dose cohort 1 subject will be administered 40mg/day PHI-101 and will be assessed for DLT ('single subject cohort'), and until an ADR ≥ [CTCAE version 5.0] grade 2 occurs, higher doses will be explored in single subject cohorts in a stepwise fashion. If an ADR ≥ [CTCAE version 5.0] grade 2 occurs, the accelerated 3+3 design will be immediately switched to the standard 3+3 scheme.
Receives: Drug: PHI-101 administration
Cohort 2 (PHI-101 80mg/day)ExperimentalIn cohort 2, the subject will be administered 80mg/day PHI-101.
Receives: Drug: PHI-101 administration
Cohort 3 (PHI-101 120mg/day)ExperimentalIn cohort 3, the subject will be administered 120mg/day PHI-101.
Receives: Drug: PHI-101 administration
Cohort 4 (PHI-101 160mg/day)ExperimentalIn cohort 4, the subject will be administered 160mg/day PHI-101.
Receives: Drug: PHI-101 administration
Cohort 5 (PHI-101 200mg/day)ExperimentalIn cohort 5, the subject will be administered 200mg/day PHI-101.
Receives: Drug: PHI-101 administration
Cohort 6 (PHI-101 240mg/day)ExperimentalIn cohort 6, the subject will be administered 240mg/day PHI-101.
Receives: Drug: PHI-101 administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with dose-limiting toxicity (DLT)

    The frequency and percentage of DLT that occurs during 1 cycle (28 days) after administration of the IP will be presented by the cohort.

    Measured: Subjects will be treated and observed for DLT through the end of the first cycle (Days 1-28)

  2. Maximum tolerated dose

    The dose of PHI-101 will be escalated until an MTD is determined, and if the MTD is not determined at the MPD, dose escalation will be ended at that dose

    Measured: Through the first cycle (Day1-28)

Secondary outcomes (23)

  1. Dose interruption (temporary discontinuation) percent (%)

    Dose interruption percent (temporary discontinuation) of the IP due to adverse events (AEs) in each cohort will be presented using frequency and percentage, and 95% exact confidence intervals (CIs).

    Measured: Through the first cycle (Day1-28)

  2. Dose reduction percent (%)

    Dose reduction percent (%) of the IP due to adverse events (AEs) in each cohort will be presented using frequency and percentage, and 95% exact confidence intervals (CIs).

    Measured: Through the first cycle (Day1-28)

  3. Dose termination (permanent discontinuation) percent (%)

    Dose termination percent (%) of the IP due to adverse events (AEs) in each cohort will be presented using frequency and percentage, and 95% exact confidence intervals (CIs).

    Measured: Through the first cycle (Day1-28)

  4. Cmax

    Maximum plasma concentration after administration

    Measured: Cycle1Day1, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle3Day1, Cycle6day1, and then, every 12 weeks until end of the study, up until 24 months (each cycle is 28 days)

  5. AUCt

    Area under the plasma concentration-time curve to the last measurable blood sampling time point, calculated by the trapezoidal method. AUC of the interval with increasing plasma concentration is calculated by a linear trapezoidal method, and AUC of the interval with decreasing plasma concentration is calculated by the log-linear trapezoidal summation. Concentrations below lower limit of quantification (LLOQ) will be excluded from calculation.

    Measured: Cycle1Day1, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle3Day1, Cycle6day1, and then, every 12 weeks until end of the study, up until 24 months (each cycle is 28 days)

  6. AUCτ

    Area under the plasma concentration-time curve from time of administration to τ (AUCτ) (τ: dosing interval)

    Measured: Cycle1Day1, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle3Day1, Cycle6day1, and then, every 12 weeks until end of the study, up until 24 months (each cycle is 28 days)

  7. AUCinf

    Area under the plasma concentration-time curve extrapolated from the time of a single dose to infinity. AUCinf = AUClast + Clast /λz

    Measured: Cycle1Day1, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle3Day1, Cycle6day1, and then, every 12 weeks until end of the study, up until 24 months (each cycle is 28 days)

  8. Tmax

    Time to maximum plasma concentration after administration

    Measured: Cycle1Day1, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle3Day1, Cycle6day1, and then, every 12 weeks until end of the study, up until 24 months (each cycle is 28 days)

  9. Tmax,ss

    Time to maximum plasma concentration at steady state

    Measured: Cycle1Day1, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle3Day1, Cycle6day1, and then, every 12 weeks until end of the study, up until 24 months (each cycle is 28 days)

  10. t1/2

    Half-life obtained by calculating ln(2)/λz, where λz is the elimination rate constant obtained from the linear regression analysis of log-linear plot at the terminal phase of the plasma concentration-time curve

    Measured: Cycle1Day1, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle3Day1, Cycle6day1, and then, every 12 weeks until end of the study, up until 24 months (each cycle is 28 days)

  11. PTF

    Fluctuation (%) between the maximum and minimum plasma concentrations at steady state

    Measured: Cycle1Day1, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle3Day1, Cycle6day1, and then, every 12 weeks until end of the study, up until 24 months (each cycle is 28 days)

  12. AR

    Ratio of systemic exposure of the drug at steady state to systemic exposure of the drug after a single dose

    Measured: Cycle1Day1, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle3Day1, Cycle6day1, and then, every 12 weeks until end of the study, up until 24 months (each cycle is 28 days)

  13. CL/F

    Apparent clearance CL/F = Dose/AUCinf

    Measured: Cycle1Day1, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle3Day1, Cycle6day1, and then, every 12 weeks until end of the study, up until 24 months (each cycle is 28 days)

  14. CLss/F

    Apparent clearance at steady state

    Measured: Cycle1Day1, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle3Day1, Cycle6day1, and then, every 12 weeks until end of the study, up until 24 months (each cycle is 28 days)

  15. Vdz/F

    Volume of distribution in the terminal phase

    Measured: Cycle1Day1, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle3Day1, Cycle6day1, and then, every 12 weeks until end of the study, up until 24 months (each cycle is 28 days)

  16. Objective response rate (ORR)

    ORR = complete response (CR) + partial response (PR)

    : For subjects who have best overall response (BOR) of complete response (CR) or partial response (PR), frequency and percentage, and 95% exact CIs will be presented by cohort evaluated according to the RECIST criteria by CT imaging.

    Measured: Until the end of the study or death, which may be up to 24 months

  17. Disease control rate (DCR)

    DCR=CR+PR+SD For subjects with BOR of CR, PR, or stable disease (SD), frequency and percentage, and 95% exact CIs will be presented by cohort and evaluated according to the RECIST criteria by CT imaging.

    Measured: Until the end of the study or death, which may be up to 24 months

  18. Duration of response (DOR)

    The time interval from response to progression or death

    Measured: Until the end of the study or death, which may be up to 24 months

  19. Progression-free survival (PFS)

    The time interval from enrollment to progression or death

    Measured: Until the end of the study or death, which may be up to 24 months

  20. Overall survival (OS)

    The time interval from enrollment to death

    Measured: Until the end of the study or death, which may be up to 24 months

  21. Time to progression (TTP)

    the time interval from enrollment date to disease recurrence or progression except death

    Measured: Until the end of the study or death, which may be up to 24 months

  22. presence of genetic variation

    homologous recombination deficiency [HRD] related genetic variation such as BRCA mutation

    Measured: at the time of enrollment

  23. Number of of adverse events

    The investigator should review the measurement, examination, and assessment results of vital signs, physical examination, laboratory tests, ECG, etc. performed for the safety assessment, and assess and record the clinical significance of abnormal results. Any clinically significant abnormal findings (medical condition or abnormal values) should be collected as AEs.

    Measured: Up to 24 months from the start of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2020
  2. Study start17 Dec 2020
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
According to the accelerated 3+3 design, the accelerated dose escalation scheme, which assesses DLT in 1 subject in each cohort, is applied until an adverse drug reaction (ADR) ≥ \[CTCAE version 5.0\] grade 2 occurs. If an ADR ≥ grade 2 occurs in a specific cohort, the accelerated 3+3 design will be immediately switched to the standard 3+3 scheme, and 3 to 6 subjects will be enrolled in each cohort. If a DLT is observed in \> 1 out of 6 subjects in a specific cohort (χ) and a DLT is observed in ≤ 1 out of 6 subjects in the cohort (χ-1) that is one level lower than the specific cohort, the one level lower cohort (χ-1) will be considered as the MTD. The dose of PHI-101 will be escalated until an MTD is determined. If the MTD is not determined at the MPD, dose escalation will be ended at that dose.
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04678102
Sponsor's protocol ID
PHI-101-002
Acronym
CREATIVE
Status last verified
Jun 2023
First submitted
29 Nov 2020
Last updated
26 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Suh DH, Chang SJ, Song T, Lee S, Kang WD, Lee SJ, Roh JW, Joo WD, Yoon JH, Jeong DH, Kim HS, Lee SJ, Ji YI, Kim HJ, Lee JW, Kim JW, Bae DS. Practice guidelines for management of ovarian cancer in Korea: a Korean Society of Gynecologic Oncology Consensus Statement. J Gynecol Oncol. 2018 Jul;29(4):e56. doi: 10.3802/jgo.2018.29.e56. Epub 2018 Mar 10.

    PubMed 29770626

  • Stover EH, Konstantinopoulos PA, Matulonis UA, Swisher EM. Biomarkers of Response and Resistance to DNA Repair Targeted Therapies. Clin Cancer Res. 2016 Dec 1;22(23):5651-5660. doi: 10.1158/1078-0432.CCR-16-0247. Epub 2016 Sep 27.

    PubMed 27678458

  • Gadducci A, Guarneri V, Peccatori FA, Ronzino G, Scandurra G, Zamagni C, Zola P, Salutari V. Current strategies for the targeted treatment of high-grade serous epithelial ovarian cancer and relevance of BRCA mutational status. J Ovarian Res. 2019 Jan 28;12(1):9. doi: 10.1186/s13048-019-0484-6.

    PubMed 30691488

  • Scambia G, Ferrandina G. A turning point in the fight against ovarian cancer? Lancet Oncol. 2018 Feb;19(2):154-156. doi: 10.1016/S1470-2045(18)30005-6. Epub 2018 Jan 18. No abstract available.

    PubMed 29361471

  • Obeidat B, Latimer J, Crawford R. Can optimal primary cytoreduction be predicted in advanced stage epithelial ovarian cancer? Role of preoperative serum CA-125 level. Gynecol Obstet Invest. 2004;57(3):153-6. doi: 10.1159/000076236. Epub 2004 Jan 15.

    PubMed 14726621

  • Smith J, Tho LM, Xu N, Gillespie DA. The ATM-Chk2 and ATR-Chk1 pathways in DNA damage signaling and cancer. Adv Cancer Res. 2010;108:73-112. doi: 10.1016/B978-0-12-380888-2.00003-0.

    PubMed 21034966

  • Jung KW, Won YJ, Kong HJ, Lee ES. Cancer Statistics in Korea: Incidence, Mortality, Survival, and Prevalence in 2016. Cancer Res Treat. 2019 Apr;51(2):417-430. doi: 10.4143/crt.2019.138. Epub 2019 Mar 18.

    PubMed 30913865

  • McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, Clarke-Pearson DL, Davidson M. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med. 1996 Jan 4;334(1):1-6. doi: 10.1056/NEJM199601043340101.

    PubMed 7494563

  • Park SJ, Chang SJ, Suh DH, Kong TW, Song H, Kim TH, Kim JW, Kim HS, Lee SJ. A phase IA dose-escalation study of PHI-101, a new checkpoint kinase 2 inhibitor, for platinum-resistant recurrent ovarian cancer. BMC Cancer. 2022 Jan 3;22(1):28. doi: 10.1186/s12885-021-09138-z.

    PubMed 34980026

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PHI-101 administration in people with Platinum-resistant Ovarian Cancer and Platinum-refractory Ovarian Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hee Seung Kim, MD (+82-2-2072-4863, bboddi0311@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with dose-limiting toxicity (DLT) (time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 1-28)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04678102, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.

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