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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04294160
Registration number
NCT04294160
Ethics application status
Date submitted
2/03/2020
Date registered
3/03/2020
Titles & IDs
Public title
A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer
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Scientific title
A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Drug Combinations in Adult Patients With Advanced or Metastatic BRAF V600 Colorectal Cancer
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Secondary ID [1]
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CADPT01C12101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
BRAF V600 Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dabrafenib
Treatment: Drugs - LTT462
Treatment: Drugs - Trametinib
Treatment: Drugs - LXH254
Treatment: Drugs - TNO155
Treatment: Other - Spartalizumab
Treatment: Other - Tislelizumab
Experimental: Dabrafenib + LTT462 backbone arm 1 - dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
Experimental: Dabrafenib + LTT462 + trametinib triplet arm 1 - dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
Experimental: Dabrafenib + LTT462 + LXH254 triplet arm 2 - dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer - Arm is closed for further enrollment.
Experimental: Dabrafenib + LTT462 + TNO155 triplet arm 3 - dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
Experimental: Dabrafenib + LTT462 + spartalizumab triplet arm 4 - dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer - Arm is closed for further enrollment.
Experimental: Dabrafenib + trametinib + TNO155 triplet arm 5 - dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
Experimental: Dabrafenib + LTT462 + Tislelizumab triplet arm 6 - dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
Treatment: Drugs: Dabrafenib
Capsule for oral use
Treatment: Drugs: LTT462
Capsule for oral use
Treatment: Drugs: Trametinib
Tablet for oral use
Treatment: Drugs: LXH254
Tablet for oral use
Treatment: Drugs: TNO155
Capsule for oral use
Treatment: Other: Spartalizumab
Liquid in vial (Concentrate for solution for infusion) for intravenous use
Treatment: Other: Tislelizumab
Liquid in vial (Concentrate for solution for infusion) for intravenous use
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence and nature of dose limiting toxicities (DLTs) in the first cycle
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Assessment method [1]
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To characterize safety and tolerability of each treatment arm tested and identify recommended doses (RD) and regimens for future studies
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Timepoint [1]
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30 months
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Primary outcome [2]
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Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, and ECGs
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Assessment method [2]
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To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future studies
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Timepoint [2]
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34 months
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Primary outcome [3]
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Frequency of dose interruptions
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Assessment method [3]
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To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future studies
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Timepoint [3]
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30 months
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Primary outcome [4]
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Frequency of dose reductions
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Assessment method [4]
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To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future studies
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Timepoint [4]
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30 months
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Primary outcome [5]
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Dose intensity
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Assessment method [5]
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To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future studies
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Timepoint [5]
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30 months
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Secondary outcome [1]
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AUClast derived from Serum/plasma concentration of individual investigational drugs within combination treatments
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Assessment method [1]
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To characterize the PK of each investigational drug within each treatment arm
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Timepoint [1]
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30 months
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Secondary outcome [2]
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Best overall response (BOR)
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Assessment method [2]
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To evaluate preliminary anti-tumor activity of each treatment arm per RECIST v1.1.
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Timepoint [2]
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34 months
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Secondary outcome [3]
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Progression free survival (PFS)
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Assessment method [3]
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To evaluate preliminary anti-tumor activity of each treatment arm per RECIST v1.1.
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Timepoint [3]
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34 months
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Secondary outcome [4]
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Overall response rate (ORR)
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Assessment method [4]
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To evaluate preliminary anti-tumor activity of each treatment arm per RECIST v1.1.
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Timepoint [4]
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34 months
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Secondary outcome [5]
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Duration of response (DOR)
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Assessment method [5]
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To evaluate preliminary anti-tumor activity of each treatment arm per RECIST v1.1.
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Timepoint [5]
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34 months
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Secondary outcome [6]
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Disease control rate (DCR)
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Assessment method [6]
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To evaluate preliminary anti-tumor activity of each treatment arm per RECIST v1.1.
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Timepoint [6]
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34 months
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Secondary outcome [7]
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Change from baseline of the PD marker DUSP6 in tumor tissue (dose escalation only)
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Assessment method [7]
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To evaluate PD effect in their respective combinations in tumor
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Timepoint [7]
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30 months
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Secondary outcome [8]
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AUCtau derived from Serum/plasma concentration of individual investigational drugs within combination treatments
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Assessment method [8]
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To characterize the PK of each investigational drug within each treatment arm
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Timepoint [8]
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30 months
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Secondary outcome [9]
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Cmax derived from Serum/plasma concentration of individual investigational drugs within combination treatments
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Assessment method [9]
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To characterize the PK of each investigational drug within each treatment arm
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Timepoint [9]
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30 months
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Secondary outcome [10]
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Tmax derived from Serum/plasma concentration of individual investigational drugs within combination treatments
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Assessment method [10]
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To characterize the PK of each investigational drug within each treatment arm
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Timepoint [10]
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30 months
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Eligibility
Key inclusion criteria
Key
* Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at baseline and during on study therapy. Exceptions may be considered after documented discussion with Novartis.
* All patients must have a BRAF V600 mutation confirmed by local assessment.
* Patients with unresectable advanced/metastatic BRAF V600 cancer of the colon or rectum with measurable disease as determined by RECIST v1.1
* Patients must have documented disease progression following, or are intolerant to, 1 or 2 lines of chemotherapy for advanced/metastatic disease
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in-situ cervical cancer, or other tumors that will not affect life expectancy
* Impairment of gastrointestinal function or gastrointestinal disease that may signficantly alter the absorption of study drugs
* History of or current evidence/risk of retinal verin occlusion or serous retinopathy
* History of or current interstitial lung disease or non-infectious pneumonitis
* Patients with a known history of testing positive for HIV
* Clinically significant cardiac disease at screening
* Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
* Pregnant or lactating women
Other protocol-defined inclusion/exclusion may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
11/10/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
122
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Novartis Investigative Site - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Massachusetts
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Country [3]
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United States of America
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State/province [3]
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Tennessee
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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Belgium
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State/province [5]
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Bruxelles
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Country [6]
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Belgium
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State/province [6]
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Leuven
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Country [7]
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Canada
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State/province [7]
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Ontario
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Country [8]
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Germany
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State/province [8]
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Dresden
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Country [9]
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Germany
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State/province [9]
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Essen
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Country [10]
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Germany
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State/province [10]
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Ulm
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Country [11]
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Israel
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State/province [11]
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Tel Aviv
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Country [12]
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Netherlands
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State/province [12]
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Amsterdam
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Country [13]
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Singapore
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State/province [13]
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Singapore
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Country [14]
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Spain
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State/province [14]
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Catalunya
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Country [15]
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Spain
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State/province [15]
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Comunidad Valenciana
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Country [16]
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Spain
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State/province [16]
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Madrid
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Country [17]
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United Kingdom
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State/province [17]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.
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Trial website
https://clinicaltrials.gov/study/NCT04294160
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04294160