MedTrace Logo

Preoperative Radiotherapy And ASTX660 in Rectum Cancer

NCT05912075 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-02-08

No results posted yet for this study

Summary

Compare two arms:

* Chemotherapy followed by tolinapant (ASTX660) in combination with Long-Course Radio Chemotherapy (LCRT), and
* Tolinapant (ASTX660) in combination with Short-Course Radiotherapy (SCRT) followed by chemotherapy For each patient, the treatment arm will be allocated on the following basis: patients will be allocated to the chemotherapy followed by LCRT arm unless they present at least one of the following criteria: contraindication to receive mFOLFIRINOX (including intolerance to irinotecan and UGT1A1\*28 polymorphism), age \> 75, general condition incompatible with the radiotherapy schedule of LCRT. In such case, patients will be allocated to the SCRT arm.

Tolinapant (ASTX660) will be administered orally once a day for 7 consecutive days every other week during 10 weeks (One week On / One week Off during 10 weeks).

Both treatment arms will have a dose escalation part to determine the MTD and/or RP2D, followed by an expansion part where up to 21 subjects will be dosed at the RP2D. Both arms will enroll simultaneously.

Conditions

  • Locally-advanced Rectal Cancer

Interventions

DRUG

mFOLFIRINOX

prior to tolinapant (ASTX660) for 6 cycles over 12 weeks

RADIATION

Pelvic radiotherapy LCRT

50-Gy total dose in 25 daily fractions of 2 Gy (5 days per week from Monday to Friday) for 5 weeks

DRUG

Capecitabine

800 mg/m2 bid for 5 days per week (From Monday to Friday) for 25 days will be given concomitantly during the 5 weeks of radiotherapy

DRUG

TOLINAPANT (ASTX660)

starting from 14 days before the first dose of radiotherapy, for 10 weeks.

RADIATION

Pelvic radiotherapy SCRT

total dose of 25 Gy, in 5 daily fractions of 5 Gy for 1 week (5 days from Monday-Friday)

DRUG

FOLFOX4

given every 2 weeks for 9 cycles, starting 10 days after the last session of short course radiotherapy

DRUG

CAPOX

every 3 weeks for 6 cycles, starting 10 days after the last session of short course radiotherapy.

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2028-01-01
Completion
2029-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05912075 on ClinicalTrials.gov