1. Relapsed Ovarian Cancer 2. Metastatic Ovarian Cancer 3. Endometrial Cancer 4. Cervical CancerPhase 2PORCHNCT04998760
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 )
A Phase 2 study testing ATG-008 and ATG-010 in people with 1. Relapsed Ovarian Cancer 2. Metastatic Ovarian Cancer 3. Endometrial Cancer 4. Cervical Cancer, run by Qi Zhou at 1 site in China.
Trial summary
1. This is 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- 1. Relapsed Ovarian Cancer 2. Metastatic Ovarian Cancer 3. Endometrial Cancer 4. Cervical Cancer
- What is being tested?
- ATG-008 and ATG-010
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2021to 9 Apr 2024
- Phase
- Phase 2
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- This is 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.
Read the detailed description
This is 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. And two cohorts of ATG-008 30 mg QD or ATG-010 80 mg QW in combination with chemotherapy will enroll subjects with platinum-sensitive ovarian cancer, platinum-resistant ovarian cancer, endometrial cancer, and cervical cancer, with about 8-12 subjects in either cohort. A total of about 64-96 subjects plan to be enrolled.
- Conditions
- 1. Relapsed Ovarian Cancer 2. Metastatic Ovarian Cancer 3. Endometrial Cancer 4. Cervical Cancer
- Being tested
- ATG-008, ATG-010
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-008Drug
ATG-008 will be orally administered at 30 mg QD combined with chemotherapies. And about 8-12 subjects plan in each cohort.
ATG-010Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| ATG-008 + Chemotherapeutics | Experimental | 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; Receives: Drug: ATG-008 |
| ATG-010 + Chemotherapeutics | Experimental | 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; Receives: Drug: ATG-010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate(ORR)
Objective response rate(ORR)
Measured: 26 months
Secondary outcomes (7)
Time to response(TTR)
Evaluated by investigators according to RECIST 1.1
Measured: 26 months
Duration of Response(DOR)
Evaluated by investigators according to RECIST 1.1
Measured: 26 months
Disease control rate(DCR)
Evaluated by investigators according to RECIST 1.1
Measured: 26 months
Overall Survival(OS)
The estimates of Kaplan-Meier
Measured: 26 months
Progression-Free Survival(PFS)
Evaluated by investigators according to RECIST 1.1
Measured: 26 months
The incidence,severity,and causality of AE,SAE
To evaluate the safety and tolerability of ATG-008 or ATG-010 in
Measured: 26 months
EORTC-QLQ-C30
To evaluate the safety and tolerability of ATG-008 or ATG-010 in
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start3 Aug 2021 (estimated)
- Primary completion9 Jan 2024 (estimated)
- Study completion9 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 1. Relapsed Ovarian Cancer 2. Metastatic Ovarian Cancer 3. Endometrial Cancer 4. Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qi Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qi Zhou, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998760
- Sponsor's protocol ID
- CQGOG0401
- Acronym
- PORCH
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04998760
- Acronym / sponsor ID
- PORCH / CQGOG0401
- Conditions
- 1. Relapsed Ovarian Cancer 2. Metastatic Ovarian Cancer 3. Endometrial Cancer 4. Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Qi ZhouUniversity, hospital or other
- Study start
- 3 Aug 2021 (estimated)
- Primary completion
- 9 Jan 2024 (estimated)
- Study completion
- 9 Apr 2024 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- This is 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.
Detailed description
This is 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. And two cohorts of ATG-008 30 mg QD or ATG-010 80 mg QW in combination with chemotherapy will enroll subjects with platinum-sensitive ovarian cancer, platinum-resistant ovarian cancer, endometrial cancer, and cervical cancer, with about 8-12 subjects in either cohort. A total of about 64-96 subjects plan to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATG-008 + Chemotherapeutics | Experimental | Drug: ATG-008ATG-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; |
| ATG-010 + Chemotherapeutics | Experimental | Drug: ATG-010perimental: 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; |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATG-008ATG-008 will be orally administered at 30 mg QD combined with chemotherapies. And about 8-12 subjects plan in each cohort. | Drug | ATG-008 + Chemotherapeutics |
| ATG-010ATG-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. | Drug | ATG-010 + Chemotherapeutics |
Primary outcome
Objective response rate(ORR)
Time frame: 26 months
Objective response rate(ORR)
7 secondary outcomes
Time to response(TTR)
Time frame: 26 months
Duration of Response(DOR)
Time frame: 26 months
Disease control rate(DCR)
Time frame: 26 months
Overall Survival(OS)
Time frame: 26 months
Progression-Free Survival(PFS)
Time frame: 26 months
The incidence,severity,and causality of AE,SAE
Time frame: 26 months
EORTC-QLQ-C30
Time frame: 26 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATG-008 and ATG-010 in people with 1. Relapsed Ovarian Cancer 2. Metastatic Ovarian Cancer 3. Endometrial Cancer 4. Cervical Cancer, run by Qi Zhou at 1 site in China.
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 6 inclusion and 5 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 10 Aug 2021. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: 26 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2021.