Home/Loved One/NCT03297606

PHASE2RECRUITING

Comparing 14 approaches for non-hodgkin lymphoma

Official title: Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR): A Phase II Basket Trial

Condition: Lymphoma, Non-HodgkinSponsor: Canadian Cancer Trials GroupTarget enrollment: 720

Interventions

DRUG

Olaparib

300mg taken twice daily

DRUG

Dasatinib

100mg administered orally once daily

DRUG

Nivolumab plus Ipilimumab

* Combination Phase - 3mg/kg nivolumab administered as an intravenous infusion over 30 minutes every 3 weeks for the first 4 doses in combination with ipilmumab 1mg/kg administered intravenously over 30 minutes, followed by the single-agent phase. * Single-Agent Phase - 480mg nivolumab administered as an intravenous infusion over 30 minutes every 4 weeks.

DRUG

Axitinib

5mg orally twice daily

DRUG

Bosutinib

500mg orally once daily

DRUG

Crizotinib

250mg orally twice daily

DRUG

Palbociclib

125mg orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days

DRUG

Sunitinib

50mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off

DRUG

Temsirolimus

25mg infused over a 30-60 minute period once a week

DRUG

Erlotinib

150mg orally, once daily

DRUG

Trastuzumab plus Pertuzumab

Trastuzumab = 3-weekly dose schedule. The recommended initial loading dose is 8mg/kg administered as a 90-minute infusion followed by 3-weekly maintenance dose of 6mg/kg administered as 90-minute infusion. Pertuzumab = 840mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420mg administered over a period of 30-60 minutes.

DRUG

Vemurafenib plus Cobimetinib

Vemurafenib = 960 mg orally every 12 hours. Cobimetinib = 60 mg orally once daily for 21 days, followed by 7 days of rest

DRUG

Vismodegib

150mg taken orally, once daily

DRUG

Tucatinib

300mg taken orally, twice daily

Canadian Sites (10)

Cross Cancer Institute

Edmonton, Alberta, Canada

RECRUITING

BCCA - Kelowna

Kelowna, British Columbia, Canada

RECRUITING

BCCA - Vancouver

Vancouver, British Columbia, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, Canada

RECRUITING

London Health Sciences Centre Research Inc.

London, Ontario, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

RECRUITING

University Health Network

Toronto, Ontario, Canada

RECRUITING

The Jewish General Hospital

Montreal, Quebec, Canada

RECRUITING

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

RECRUITING

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

RECRUITING

See who this study is looking for26 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

+Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.
+(screening step - non-drug specific)
+Adult (≥ 18 yrs) patient with a histologically-proven incurable metastatic solid tumour (excluding primary brain tumours), multiple myeloma or B cell non-Hodgkin lymphoma (excluding CLL, SLL and HCL), for whom there is no standard treatment known to prolong life, or who has refused such treatment.
+Patients must have normal organ function as follows:
+Absolute neutrophil count: ≥ 1.5 x 10\^9/L for solid tumours; ≥ 1.0 x 10\^9/L for neurologic malignancies
+Platelets ≥ 75 x 10\^9/L (or ≥ 50 x 10\^9/L if bone marrow involvement by myeloma or lymphoma).
+Total bilirubin ≤ 1.5 x UNL.
+AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal value unless liver metastases are present in which case they must be \< 5 x ULN;
+Serum creatinine ≤ 1.5 x UNL or calculated or measured creatinine clearance ≥ 50mg/min/1.73µ\^2
+Patients must have measurable disease
+Results must be available from tumour genomic or protein expression testing (if used to identify genetic variants), from one of the initiatives / groups listed in protocol Appendix VII. The test may have been performed on the primary tumour or a metastatic deposit (including bone marrow), or blood, in a diagnostic or research laboratory and must reveal a potentially actionable variant.
+Patient consent (Main Study Consent for the screening step) must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to the screening step to document their willingness to participate
+Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre or a CCTG IND site. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial.
+ECOG performance status 0-2.

Exclusion

−Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within one month prior to screening. All patients with previously treated brain metastases must be stable (clinically and radiologically) for at least one month after completion of treatment and either off steroid treatment or only taking physiological doses of steroids prior to the screening step.
−(screening step - non-drug specific)
−Patients with prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
−Patients with ongoing toxicity ≥ CTCAE grade 2, other than peripheral neuropathy or asymptomatic, corrected biochemical toxicities (e.g. hypothyroidism corrected by thyroid replacement), related to prior anti-tumour treatment. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.
−Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.
−Patients with known left ventricular ejection fraction (LVEF) \< 40%.
−Patients with stroke (including TIA) or acute myocardial infarction within three months prior to the screening step.
−Patients with acute gastrointestinal bleeding within one month prior to the screening step.
−Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations.
−Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician.
−Lactating and nursing women
−Patients concurrently receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g. megestrol acetate, bisphosphonates) or ongoing castration-intent therapy for prostate cancer. These medications must have been started ≥ one month prior to enrollment on this study. Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific ineligibility criteria.

5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning

What this study is

This study is testing a treatment for a condition.

Phase 2 — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effects.

What is being given or done in this study: Olaparib, Dasatinib, Nivolumab plus Ipilimumab, Axitinib, and 10 more.

From the trial registry

Built from these fields:

designModule.designInfo.primaryPurpose
designModule.phases
armsInterventionsModule.interventions[].name

How the study is run

Groups are assigned by the study team using set rules, rather than by chance.

This study is open-label: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

designModule.designInfo.allocation
designModule.designInfo.maskingInfo.masking

Is there a placebo?

This study does not list a placebo group.

There are 14 groups in this study.

From the trial registry

Built from this field:

armsInterventionsModule.armGroups[].type

Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteers.

These are the criteria the study lists. Only the trial site can decide whether someone can take part.

From the trial registry

Built from these fields:

eligibilityModule.minimumAge
eligibilityModule.sex
eligibilityModule.healthyVolunteers

How big and how long

The study aims to enrol about 720 people.

The study is currently expected to finish around January 2027.

The main measurement is taken over: 4 years.

From the trial registry

Built from these fields:

designModule.enrollmentInfo.count
statusModule.completionDateStruct.date
outcomesModule.primaryOutcomes[].timeFrame

What the study measures

Objective response rate defined as the number of patients with complete response or partial response — measured over 4 years.

From the trial registry

Built from these fields:

outcomesModule.primaryOutcomes[].measure
outcomesModule.primaryOutcomes[].timeFrame

Source: NCT03297606 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?