Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05912075

Preoperative Radiotherapy And ASTX660 in Rectum Cancer

Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2024-02-08

78

Participants Needed

2

Research Sites

262 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Preoperative Radiotherapy And ASTX660 in Rectum Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Locally advanced rectal cancer unlikely to be fully removed by surgery alone
  • Tumor or lymph node within 2 mm of mesorectal fascia on pelvic MRI or N2 disease
  • No metastatic disease on chest and abdomen CT scan
  • Age 18 years or older at consent
  • For LCRT arm, completion of at least 4 cycles of mFOLFIRINOX chemotherapy
  • ECOG performance status of 0 or 1
  • Adequate organ function as shown by specific laboratory test limits for liver, kidney, blood counts, enzymes, and coagulation
  • Negative pregnancy test for women of childbearing potential before first treatment
  • Use of effective contraception or surgical sterilization for women and men of childbearing potential during and 6 months after study
  • Ability and willingness to comply with study procedures and visits
  • Affiliation to a social security system or beneficiary status
Not Eligible

You will not qualify if you...

  • Contraindications to MRI such as pacemakers, claustrophobia, or excessive weight
  • Participation in another investigational study within 3 months
  • Any anticancer therapy during this study participation period
  • Hypersensitivity to tolinapant or components including 5-FU, capecitabine, oxaliplatin, irinotecan, or known enzyme deficiencies
  • Prior pelvic radiotherapy
  • Conditions preventing radiotherapy like fistulas, severe ulcerative colitis, active Crohn's disease, or prior adhesions
  • Conditions preventing chemotherapy such as pneumonitis, pulmonary fibrosis, or vitamin B12-deficiency anemias
  • Previous rectal surgery or investigational treatment for rectal cancer
  • Poor medical risk from other systemic diseases
  • Life-threatening illnesses or conditions compromising safety or drug metabolism
  • History or risk of serious cardiac disease as defined by specific heart function tests and conditions
  • Severe nausea/vomiting, chronic gastrointestinal diseases, or major bowel function disturbances
  • Known active HIV, hepatitis B or C infection
  • Peripheral sensory neuropathy grade above 2
  • Pregnancy or breastfeeding
  • Legal incapacity or inability to consent
  • Contraindication to live vaccines such as yellow fever vaccine

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Centre Léon Bérard

Lyon, Rhöne, France, 69373

Not Yet Recruiting

2

Gustave Roussy

Villejuif, Val De Marne, France, 94805

Actively Recruiting

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Research Team

E

Eric DEUTSCH, MD, PhD

CONTACT

C

Catherine RICHON

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Preoperative Radiotherapy And ASTX660 in Rectum Cancer | DecenTrialz