Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, Serabelisib With Paclitaxel, and Paclitaxel Alone in Patients With Advanced/Recurrent Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

A Randomized, Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, Serabelisib With Paclitaxel, and Paclitaxel Alone in Patients With Advanced or Recurrent Endometrial Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06463028
• Other study ID #: FTH-PIK-201
• Secondary ID: GOG-3111
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 30, 2024
• Est. completion date: September 2029

Study information

• Verified date: June 2024
• Source: Faeth Therapeutics
• Contact: Medical Monitor
• Phone: (708)406-9282
• Email: clinicaltrials[@]faeththerapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel and the efficacy and safety of serabelisib with paclitaxel versus paclitaxel alone in participants with advanced or recurrent endometrial cancer.

Description:

This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel and the efficacy and safety of serabelisib with paclitaxel versus paclitaxel alone in participants with advanced or recurrent endometrial cancer who have failed prior systemic therapies, including a platinum-based therapy and an immune checkpoint inhibitor, either separately or together.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 2029
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of endometrioid endometrial carcinoma.

• Documented evidence of advanced or recurrent endometrial cancer that is not amenable to surgery/radiation for curative intent.

• Participant has received at least 1 but not more than 3 prior systemic therapies.

• PI3K/AKT/mTOR pathway gene alteration status available

• At least 1 measurable target lesion according to RECIST v1.1

• Eastern Cooperative Oncology Group (ECOG) performance status of = 1 at Screening.

• Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods..

Exclusion Criteria:

• Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study

• Active malignancy (except for endometrial cancer, definitively treated in-situ carcinomas [e.g., breast, cervix, bladder], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible.

• Gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment.

• Clinically significant hemoptysis or tumor bleeding.

• Significant cardiovascular impairment.

• Active, uncontrolled (requiring systemic antimicrobial therapy) infection.

• Concurrent participation in another therapeutic clinical trial.

• Prior radiation therapy within 21 days prior to start of study treatment.

• Strong CYP3A4 inhibitors, strong CYP1A2 inhibitors or CYP1A2 inducers, or clinically significant CYP3A4 inducers within 7 days before the first dose of study intervention, or participants who require treatment with strong CYP3A4 inhibitors or inducers during the study.

• Participants who require PPIs during the study.

• Prolongation of QTc interval to >480 ms.

• HbA1c = 7.0%, fasting serum glucose > 130 mg/dL, or fasting triglycerides > 300 mg/dL.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• Sapanisertib
Oral
• Serabelisib
Oral
• Paclitaxel
Infusion

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Faeth Therapeutics	GOG Foundation

References & Publications (1)

Starks DC, Rojas-Espaillat L, Meissner T, Williams CB. Phase I dose escalation study of dual PI3K/mTOR inhibition by Sapanisertib and Serabelisib in combination with paclitaxel in patients with advanced solid tumors. Gynecol Oncol. 2022 Sep;166(3):403-409. doi: 10.1016/j.ygyno.2022.07.005. Epub 2022 Jul 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	Defined as the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR).	Up to 2 years
Secondary	Progression free survival (PFS)	Defined as the time from randomization until the date of disease progression (per RECIST 1.1) or death.	Up to 5 years.
Secondary	Overall survival (OS)	Defined as the time from randomization to death.	Up to 5 years.
Secondary	Clinical benefit rate (CBR)	Defined as the percentage of participants who achieve confirmed complete response (CR), confirmed partial response (PR), or have stable disease (SD) of at least 16 or 24 weeks.	Up to 5 years.
Secondary	Duration of response (DoR)	Defined as time from the date of first documented response until date of documented progression or death.	Up to 5 years.
Secondary	Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs)	Graded according to the National Cancer Institute (NCI CTCAE V5.0).	Up to 2 years.

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