Locally-advanced Rectal CancerPhase 1PRAAR1NCT05912075
Preoperative Radiotherapy And ASTX660 in Rectum Cancer
A Phase 1 study testing mFOLFIRINOX, Pelvic radiotherapy LCRT and Capecitabine in people with Locally-advanced Rectal Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally-advanced Rectal Cancer
- What is being tested?
- mFOLFIRINOX, Pelvic radiotherapy LCRT and Capecitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Dec 2023to Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced rectum cancer where primary resection without chemoradiotherapy is unlikely to achieve clear margins as defined by:
- a distance between the tumor or its lymph node and the mesorectal fascia ≤ 2 mm on the pelvic MRI at diagnosis.
- *and/or N2
- No evidence of metastatic disease on CT-scan (chest and abdomen), including resectable metastases
- Age : ≥ 18 years old at the time of informed consent
- Successfully received at least 4 cycles and up to 6 cycles of mFOLFIRINOX (LCRT arm only)
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- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 or 1
- Acceptable organ functions, as evidenced by the following laboratory data:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0×upper limit of normal (ULN)
- Total serum bilirubin ≤1.5×ULN
- Absolute neutrophil count (ANC): ≥2,000 cells/mm^3
- Platelet count: ≥100,000 cells/mm^3
- Hemoglobin: ≥ 9.0 g/dL
- Serum creatinine levels ≤1.5×ULN, or calculated (by Cockcroft-Gault formula or other accepted formula) or measured creatinine clearance ≥50 mL/min
- Amylase and lipase ≤1.5xULN
- Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) ≤ 1.5.
- Women of childbearing potential must have a negative serum β-HCG pregnancy test within 3 days prior to the administration of the first study treatment and/or urine pregnancy 12 hours prior to the administration of the first study treatment.
- Female subjects of childbearing potential should be willing to use a highly effective method of contraception or be surgically sterile, or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy.
- Also, it is recommended that women of childbearing potential partner use a highly effective method of contraception.
- Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient must be able and willing to comply with study visits and procedures as per protocol.
- Patient must be affiliated to a social security system or beneficiary of the same.
Who cannot join
- Any contraindications to MRI (e.g. subjects with pacemakers, claustrophobia, excessive weight, etc).
- Participation in another clinical study with an investigational product during the last 3 months.
- No other anticancer therapy during study participation. (however, informed consent can be signed during mFOLFIRINOX for patients willing to enter the LCRT arm).
- Hypersensitivity to tolinapant (ASTX660) or excipients of the drug product, or to any other component of the study treatment regimen, including:
- 5-FU, capecitabine and known dihydropyrimidine dehydrogenase (DPD) deficiency, or
- Oxaliplatin, or
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- Irinotecan and known Gilbert disease or genotype UGT1A1 (LCRT arm only)
- Previous radiotherapy in the pelvic region
- Preexisting condition that would deter radiotherapy, e.g. fistulas, severe ulcerative colitis (including subjects currently taking sulphasalazine), active Crohn's disease, prior adhesions
- Preexisting condition that would deter chemotherapy, e.g. pneumonitis, pulmonary fibrosis, pernicious anemia or other anemias caused by vitamin B12 deficiency
- Prior rectal surgery
- Prior investigational treatment for rectal cancer
- Poor medical risk because of systemic diseases (e.g., uncontrolled infections, uncontrolled diabetes) in addition to the qualifying disease under study
- Life-threatening illness, significant organ system dysfunction, or other condition that, in the investigator's opinion, could compromise subject safety or the integrity of the study outcomes, or interfere with the absorption or metabolism of tolinapant (ASTX660)
- A history of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions:
- Abnormal left ventricular ejection fraction (LVEF; <50%) on echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
- Congestive cardiac failure of ≥ Grade 3 severity according to New York Heart Association (NYHA) functional classification defined as subjects with marked limitation of activity and who are comfortable only at rest
- Unstable cardiac disease including unstable angina or hypertension as defined by the need for overnight hospital admission within the last 3 months (90 days)
- History or presence of complete left bundle branch block, third-degree heart block, cardiac pacemaker, or clinically significant arrhythmia
- Concurrent treatment with any medication that prolongs QT interval and may induce torsades de pointes and which cannot be discontinued at least 2 weeks before treatment with tolinapant (ASTX660)
- Personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy
- Screening 12-lead ECG with measurable QTc interval (according to either Fridericia's or Bazett's correction) of ≥470 msec)
- Any other condition that, in the opinion of the investigator, could put the subject at increased cardiac risk
- Refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease and/or bowel obstruction), or significant bowel resection that may impair adequate absorption and bioavailability of study drug. Major disturbance of bowel function (e.g. gross fecal incontinence or requiring > 6 mg loperamide each day).
- Known history of human immunodeficiency virus (HIV) infection; or seropositive results consistent with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
- Peripheral sensory neuropathy grade >2
- Pregnancy or ongoing breastfeeding
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
- Yellow fever vaccine and live attenuated vaccines are contraindicated due to risk of severe vaccine-induced infection.
- NB :
- The currently authorized COVID-19 vaccines are not live vaccines and therefore can be safely administered.
- For patients registered in LCRT, all eligibility criteria will be fulfilled during mFOLFIRINOX (until 2 weeks after the end of mFOLFIRINOX).
- For patients registered in SCRT, all eligibility criteria will be fulfilled before any treatment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Centre Léon Bérard
Lyon, Rhöne, 69373
Jessica SERRAND, MD, Jessica.SERRAND@lyon.unicancer.fr
Alexandra LAURET, Alexandra.LAURET@lyon.unicancer.fr
- Recruiting
Gustave Roussy
Villejuif, Val De Marne, 94805
Eric DEUTSCH, Md, PhD, Eric.DEUTSCH@gustaveroussy.fr
Catherine RICHON, catherine.richon@gustaveroussy.fr
About this study
Official title: An Open-Label Multicenter Phase 1b Study of Tolinapant (ASTX660) in Combination With Radiotherapy/Chemoradiotherapy (RT/CRT) in Preoperative Treatment of Patients With Rectum Cancer (PRAAR 1: Preoperative Radiotherapy And ASTX660 in Rectum Cancer)
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.
Read more
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
- Being tested
- mFOLFIRINOX, Pelvic radiotherapy LCRT, Capecitabine, TOLINAPANT (ASTX660), Pelvic radiotherapy SCRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFIRINOXDrug
prior to tolinapant (ASTX660) for 6 cycles over 12 weeks
Pelvic radiotherapy LCRTRadiation
50-Gy total dose in 25 daily fractions of 2 Gy (5 days per week from Monday to Friday) for 5 weeks
CapecitabineDrug
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
TOLINAPANT (ASTX660)Drug
starting from 14 days before the first dose of radiotherapy, for 10 weeks.
Pelvic radiotherapy SCRTRadiation
total dose of 25 Gy, in 5 daily fractions of 5 Gy for 1 week (5 days from Monday-Friday)
FOLFOX4Drug
given every 2 weeks for 9 cycles, starting 10 days after the last session of short course radiotherapy
CAPOXDrug
Also called Capecitabine + Oxaliplatine
every 3 weeks for 6 cycles, starting 10 days after the last session of short course radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| LCRT | Experimental | LCRT: Long-course pelvic radiotherapy given concomitantly with capecitabine chemotherapy and TOLINAPANT (ASTX660):
* mFOLFIRINOX will be given prior to tolinapant (ASTX660) for 6 cycles over 12 weeks;
* Pelvic radiotherapy to a planned volume at a 50-Gy total dose in 25 daily fractions of 2 Gy (5 days per week from Monday to Friday) for 5 weeks;
* Chemotherapy (capecitabine) at 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;
* TOLINAPANT (ASTX660) starting from 14 days before the first dose of radiotherapy, for 10 weeks. Tolinapant (ASTX660) will be given concomitantly with RT and chemotherapy for 5 weeks. Receives: Drug: mFOLFIRINOX; Radiation: Pelvic radiotherapy LCRT; Drug: Capecitabine; Drug: TOLINAPANT (ASTX660) |
| SCRT | Experimental | SCRT: Short course pelvic radiotherapy followed by chemotherapy in combination with TOLINAPANT (ASTX660):
* Pelvic radiotherapy will be given to a planned volume at a total dose of 25 Gy, in 5 daily fractions of 5 Gy for 1 week (5 days from Monday-Friday)
* Chemotherapy (FOLFOX4): given every 2 weeks for 9 cycles, starting 10 days after the last session of short course radiotherapy. Alternative: CAPOX given every 3 weeks for 6 cycles, starting 10 days after the last session of short course radiotherapy.
* Tolinapant (ASTX660) starting from 14 days before the first dose of radiotherapy, for 10 weeks. Tolinapant (ASTX660) will be given concomitantly with RT for 5 days. Receives: Drug: TOLINAPANT (ASTX660); Radiation: Pelvic radiotherapy SCRT; Drug: FOLFOX4; Drug: CAPOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs)
ASTX660-related toxicities graded using NCI CTCAE V5.0
Measured: during the 10 weeks of tolinapant (ASTX660) treatment
Secondary outcomes (4)
Overall survival
Measured: 2 years after surgery
Disease-free survival (DFS)
Measured: 2 years after surgery
Local recurrence-free survival
Measured: 2 years after surgery
Distant metastasis-free survival
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start19 Dec 2023
- Primary completion1 Jan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally-advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative phase 1b trial with randomization
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912075
- Sponsor's protocol ID
- 2021-005363-43
- Other IDs
- 2021/3339
- Acronym
- PRAAR1
- Status last verified
- Feb 2024
- First submitted
- 12 Jun 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Multicenter Phase 1b Study of Tolinapant (ASTX660) in Combination With Radiotherapy/Chemoradiotherapy (RT/CRT) in Preoperative Treatment of Patients With Rectum Cancer (PRAAR 1: Preoperative Radiotherapy And ASTX660 in Rectum Cancer)
- ClinicalTrials.gov ID
- NCT05912075
- Acronym / sponsor ID
- PRAAR1 / 2021-005363-43
- Conditions
- Locally-advanced Rectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 22 Jun 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative phase 1b trial with randomization
| Arm | Type | Receives |
|---|---|---|
| LCRT | Experimental | Drug: mFOLFIRINOX, Radiation: Pelvic radiotherapy LCRT, Drug: Capecitabine, Drug: TOLINAPANT (ASTX660)LCRT: Long-course pelvic radiotherapy given concomitantly with capecitabine chemotherapy and TOLINAPANT (ASTX660): * mFOLFIRINOX will be given prior to tolinapant (ASTX660) for 6 cycles over 12 weeks; * Pelvic radiotherapy to a planned volume at a 50-Gy total dose in 25 daily fractions of 2 Gy (5 days per week from Monday to Friday) for 5 weeks; * Chemotherapy (capecitabine) at 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; * TOLINAPANT (ASTX660) starting from 14 days before the first dose of radiotherapy, for 10 weeks. Tolinapant (ASTX660) will be given concomitantly with RT and chemotherapy for 5 weeks. |
| SCRT | Experimental | Drug: TOLINAPANT (ASTX660), Radiation: Pelvic radiotherapy SCRT, Drug: FOLFOX4, Drug: CAPOXSCRT: Short course pelvic radiotherapy followed by chemotherapy in combination with TOLINAPANT (ASTX660): * Pelvic radiotherapy will be given to a planned volume at a total dose of 25 Gy, in 5 daily fractions of 5 Gy for 1 week (5 days from Monday-Friday) * Chemotherapy (FOLFOX4): given every 2 weeks for 9 cycles, starting 10 days after the last session of short course radiotherapy. Alternative: CAPOX given every 3 weeks for 6 cycles, starting 10 days after the last session of short course radiotherapy. * Tolinapant (ASTX660) starting from 14 days before the first dose of radiotherapy, for 10 weeks. Tolinapant (ASTX660) will be given concomitantly with RT for 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Locally advanced rectum cancer where primary resection without chemoradiotherapy is unlikely to achieve clear margins as defined by:
- a distance between the tumor or its lymph node and the mesorectal fascia ≤ 2 mm on the pelvic MRI at diagnosis.
- No evidence of metastatic disease on CT-scan (chest and abdomen), including resectable metastases
- Age : ≥ 18 years old at the time of informed consent
- Successfully received at least 4 cycles and up to 6 cycles of mFOLFIRINOX (LCRT arm only)
Key exclusion criteria (33 listed)
- Any contraindications to MRI (e.g. subjects with pacemakers, claustrophobia, excessive weight, etc).
- Participation in another clinical study with an investigational product during the last 3 months.
- No other anticancer therapy during study participation. (however, informed consent can be signed during mFOLFIRINOX for patients willing to enter the LCRT arm).
- Hypersensitivity to tolinapant (ASTX660) or excipients of the drug product, or to any other component of the study treatment regimen, including:
- Previous radiotherapy in the pelvic region
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 |
|---|---|---|
| mFOLFIRINOXprior to tolinapant (ASTX660) for 6 cycles over 12 weeks | Drug | LCRT |
| Pelvic radiotherapy LCRT50-Gy total dose in 25 daily fractions of 2 Gy (5 days per week from Monday to Friday) for 5 weeks | Radiation | LCRT |
| Capecitabine800 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 | LCRT |
| TOLINAPANT (ASTX660)starting from 14 days before the first dose of radiotherapy, for 10 weeks. | Drug | LCRT, SCRT |
| Pelvic radiotherapy SCRTtotal dose of 25 Gy, in 5 daily fractions of 5 Gy for 1 week (5 days from Monday-Friday) | Radiation | SCRT |
| FOLFOX4given every 2 weeks for 9 cycles, starting 10 days after the last session of short course radiotherapy | Drug | SCRT |
| CAPOXAlso: Capecitabine + Oxaliplatineevery 3 weeks for 6 cycles, starting 10 days after the last session of short course radiotherapy. | Drug | SCRT |
Primary outcome
Dose-limiting toxicities (DLTs)
Time frame: during the 10 weeks of tolinapant (ASTX660) treatment
ASTX660-related toxicities graded using NCI CTCAE V5.0
4 secondary outcomes
Overall survival
Time frame: 2 years after surgery
Disease-free survival (DFS)
Time frame: 2 years after surgery
Local recurrence-free survival
Time frame: 2 years after surgery
Distant metastasis-free survival
Time frame: 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mFOLFIRINOX, Pelvic radiotherapy LCRT and Capecitabine in people with Locally-advanced Rectal Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 2 sites in France.
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 22 inclusion and 33 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: looking for participants now, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric DEUTSCH, MD, PhD (+33 (0)1 42 11 65 73, Eric.DEUTSCH@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (DLTs) (time frame: during the 10 weeks of tolinapant (ASTX660) treatment). 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 8 Feb 2024.