- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04998760
A Study to Evaluate Dual mTORC1/2 Inhibitor (ATG 008) or Selective Inhibitor of Nuclear Export Compound (ATG-010) in Combination With Chemotherapy in Patients With Relapsed or Metastatic Ovarian Cancer, Endometrial Cancer, and Cervical Cancer ( PORCH ) (PORCH)
A Multi-center Clinical Study to Evaluate Dual mTORC1/2 Inhibitor (ATG 008) or Selective Inhibitor of Nuclear Export Compound (ATG-010) in Combination With Chemotherapy in Patients With Relapsed or Metastatic Ovarian Cancer, Endometrial Cancer, and Cervical Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Chongqing
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Chongqing, Chongqing, China, 400030
- Chongqing Cancer Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Understand and voluntarily sign informed consent (ICF).
- Age 18 to 70 (including 18 and 70).
- Histopathological or clinical diagnosis of high grade relapsed or metastatic serous ovarian cancer (including fallopian tube cancer and peritoneal cancer), endometrial cancer (including endometrial carcinosarcoma) and cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma); received ≤1 line treatment after recurrence.
- At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or
1. 6. Life expectancy >3 months. 7. Women of childbearing potential must agree to use effective contraceptives from signing the informed consent until 180 days after the last dose of study drug. Women of childbearing age include premenopausal women and women within 2 years after menopause. Women of childbearing age must have a negative blood pregnancy test at screening
Exclusion Criteria:
1. Histopathological diagnosis of sarcoma, carcinosarcoma (except endometrial carcinosarcoma). 2. Low-grade serous carcinoma, clear cell carcinoma, and mucinous carcinoma. 3. Symptomatic central nervous system metastases (except those who have been previously treated for brain metastases but have been keeping stable of disease status for 4 weeks prior to screening). 4. Participated in other clinical trials within 4 weeks prior to screening. 5. Received major surgery within 4 weeks prior to screening or expect to proceed a major surgical treatment during the study period. 6. Received systemic chemotherapy, radiotherapy, traditional Chinese medicine with anti tumor indications within 4 weeks prior to screening, or plan to receive therapeutic radiotherapy during the study period. 7. Received live attenuated vaccine within 4 weeks before screening, or plan to receive live attenuated vaccine during screening. 8. Using systemic immunosuppressive drugs currently or used within two weeks before screening with the following exceptions:
- Intranasal, inhaled, topical steroid or topical steroid injection (eg, intraarticular),
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/ day of prednisone or equivalent, OR
Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication). 9. Suffer from swallowing dysfunction, active gastrointestinal diseases or other diseases or disorders that affect the absorption, distribution, metabolism, and excretion of ATG-008 or ATG 010. 10. Hepatitis B virus (HBV) infection (Hepatitis B surface antigen [HBsAg] positive) or active hepatitis C virus (HCV) infection (HCVRNA positive at screening).
11. Subjects with a history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome. 12. Hypersensitive or known to be allergic to ATG-008, ATG-010 or chemotherapeutic agents or to active or inactive ingredients of drugs with similar chemical structures. 13. Have a history of organ transplantation (eg, liver transplantation or autologous stem cell transplantation). 14. Known as alcohol or drug dependent. 15. Female subjects who are pregnant or lactating. 16. Judgment by the investigator that the subject should not participate in the study by consideration of the complications or other conditions which might affect their adherence to the protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ATG-008 + Chemotherapeutics
ATG-008: Oral, 30 mg QD+Paclitaxel: 175 mg/m2, intravenous infusion >3 h, Day 1, Q3W; ATG-008: Oral, 30 mg QD+Carboplatin: AUC = 5, intravenous infusion >1 h, Day 1, Q3W or Cisplatin: 75 mg/m2, intravenous infusion >1h, Day 2, Q3W ; ATG-008: Oral, 30 mg QD+Doxorubicin hydrochloride liposome, 40 mg/m2, Day 1; Q4W;
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ATG-008 will be orally administered at 30 mg QD combined with chemotherapies.
And about 8-12 subjects plan in each cohort.
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Experimental: ATG-010 + Chemotherapeutics
perimental: ATG-010 + Chemotherapeutics ATG-010: Oral, 80 mg QW, Day 1/week of treatment cycles +Paclitaxel: 175 mg/m2, intravenous infusion >3 h, Day 1, Q3W; ATG-010: Oral, 80 mg QW, Day 1/week of treatment cycles +Carboplatin: AUC = 5, intravenous infusion >1 h, Day 1, Q3W or Cisplatin: 75 mg/m2, intravenous infusion >1h, Day 2, Q3W ; ATG-010: Oral, 80 mg QW, Day 1/week of treatment cycles +Doxorubicin hydrochloride liposome, 40 mg/ m2, Day 1; Q4W; |
ATG-010 will be orally administered at 30 mg QD and 80 mg QW combined with chemotherapies.
And about 8-12 subjects plan in each cohort.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate(ORR)
Time Frame: 26 months
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Objective response rate(ORR)
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26 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to response(TTR)
Time Frame: 26 months
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Evaluated by investigators according to RECIST 1.1
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26 months
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Duration of Response(DOR)
Time Frame: 26 months
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Evaluated by investigators according to RECIST 1.1
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26 months
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Disease control rate(DCR)
Time Frame: 26 months
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Evaluated by investigators according to RECIST 1.1
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26 months
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Overall Survival(OS)
Time Frame: 26 months
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The estimates of Kaplan-Meier
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26 months
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Progression-Free Survival(PFS)
Time Frame: 26 months
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Evaluated by investigators according to RECIST 1.1
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26 months
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The incidence,severity,and causality of AE,SAE
Time Frame: 26 months
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To evaluate the safety and tolerability of ATG-008 or ATG-010 in
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26 months
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EORTC-QLQ-C30
Time Frame: 26 months
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To evaluate the safety and tolerability of ATG-008 or ATG-010 in
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26 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Uterine Cervical Neoplasms
- Ovarian Neoplasms
- Endometrial Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- CQGOG0401
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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