720 Participants Needed

Targeted Cancer Drugs for Cancer

(CAPTUR Trial)

Recruiting at 12 trial locations
JD
Overseen ByJanet Dancey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests targeted therapies, which are cancer drugs designed to attack specific abnormal gene changes in cancer cells. The aim is to observe how these drugs affect both the patient and their cancer. Multiple drugs, including Axitinib, Bosutinib, Crizotinib, Dasatinib, Erlotinib, Nivolumab plus Ipilimumab, Olaparib, Palbociclib, Sunitinib, Temsirolimus, Trastuzumab plus Pertuzumab, Tucatinib, Vemurafenib plus Cobimetinib, and Vismodegib, are tested across different groups, each focusing on specific gene changes. This trial seeks patients with incurable metastatic solid tumors or certain types of lymphoma who lack standard treatment options known to extend life. Participants should be willing to undergo genetic testing to identify actionable gene changes in their tumors. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot be on any other anti-cancer therapy, except for certain supportive care medications that may have an anti-cancer effect, which must have been started at least one month before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments in this trial have different safety profiles. Here are some key points:

Axitinib has been studied in several trials and can cause liver issues in about 39% of patients, with serious liver problems in 20% of cases.

Bosutinib is generally well-tolerated in patients with chronic myeloid leukemia, though almost all patients experience some side effects.

Crizotinib is used for certain lung cancers and is linked to a good survival rate, but its safety in very young patients remains unknown.

Dasatinib can cause serious side effects, including high blood pressure in the lungs and other blood-related issues.

Erlotinib is usually well-tolerated for lung cancer, with mild to moderate side effects like rash and diarrhea.

Nivolumab plus Ipilimumab can cause serious immune-related side effects in a small percentage of patients, some of which can be fatal.

Olaparib, used for ovarian cancer, can cause serious reactions like blood disorders in about 31% of patients.

Palbociclib often leads to low white blood cell counts, which is common but manageable.

Sunitinib has been safely used for kidney cancer, though it's not approved for lung cancer.

Temsirolimus is generally well-tolerated, with manageable side effects.

Trastuzumab plus Pertuzumab can cause serious side effects, but these are expected and manageable with proper care.

Tucatinib has shown serious side effects in about 26% of patients, including diarrhea and nausea.

Vemurafenib plus Cobimetinib can lead to a higher rate of serious side effects, but these are similar to other treatments.

Vismodegib is considered safe for advanced skin cancer, though its safety in children is not known.

Overall, these treatments have known safety profiles, with common side effects that are usually manageable. Discussing these with healthcare providers is important to understand the risks and benefits.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they each target specific genetic mutations or pathways in cancer cells, offering a more personalized approach than many current options. Unlike traditional chemotherapy, which can affect both healthy and cancerous cells, these drugs, such as Nivolumab plus Ipilimumab, focus on boosting the immune system to recognize and attack cancer cells. Other treatments like Olaparib and Palbociclib target specific proteins or enzymes involved in cancer cell growth and repair, which may lead to better outcomes with fewer side effects. This tailored approach allows for more precise interventions, potentially improving effectiveness and reducing harm to healthy cells.

What evidence suggests that this trial's treatments could be effective for cancer?

Research shows that each treatment in this trial can target specific genetic changes in certain cancers. For instance, crizotinib, one of the treatments under study, has proven effective for patients with advanced non-small cell lung cancer, particularly those with ALK-positive mutations, showing a high response rate. Studies have shown that dasatinib significantly improves survival rates in patients with chronic myeloid leukemia. The combination of nivolumab and ipilimumab, also part of this trial, has demonstrated long-term survival benefits in cancers like melanoma. Vemurafenib with cobimetinib has helped patients with BRAF mutation-positive melanoma live longer without cancer progression. Lastly, vismodegib has shown good results in treating basal cell carcinoma by targeting the Hedgehog signaling pathway, which is involved in tumor growth. Each of these drugs targets specific genetic changes, offering a more precise treatment approach for cancer patients.36789

Who Is on the Research Team?

LS

Lillian Siu

Principal Investigator

Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada

DJ

Daniel J Renouf

Principal Investigator

BCCA - Vancouver Cancer Centre, Vancouver BC, Canada

Are You a Good Fit for This Trial?

Adults with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma without standard life-prolonging treatment options. Participants must be over 18, have an ECOG performance status of 0-2, normal organ function and measurable disease. They should agree to use effective contraception and not have other conditions that could affect the trial's safety or results.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.
I am an adult with an incurable cancer (not brain cancer) and no life-prolonging treatment options or have refused them.
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, Patient consent (Main Study Consent for the screening step) must be appropriately obtained in accordance with applicable local and regulatory requirements, Patients must be accessible for treatment and follow-up, Women/men of childbearing potential must have agreed to use a highly effective contraceptive method

Exclusion Criteria

I do not have severe side effects from previous cancer treatments, except for manageable nerve pain or corrected thyroid issues.
I am not on any cancer treatments except for supportive care or ongoing hormone therapy for prostate cancer.
I have not had a stroke or heart attack in the last 3 months.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive targeted therapy drugs specific to identified genetic changes in their cancer

Variable, based on individual response

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

What Are the Treatments Tested in This Trial?

Interventions

  • Axitinib
  • Bosutinib
  • Crizotinib
  • Dasatinib
  • Erlotinib
  • Nivolumab plus Ipilimumab
  • Olaparib
  • Palbociclib
  • Sunitinib
  • Temsirolimus
  • Trastuzumab plus Pertuzumab
  • Tucatinib
  • Vemurafenib plus Cobimetinib
  • Vismodegib
Trial Overview The CAPTUR study is testing targeted therapy drugs on patients with specific abnormal gene changes in their cancer. These therapies aim at the genetic level to block cancer growth and spread. The trial includes a variety of drugs like Erlotinib and Nivolumab plus Ipilimumab among others.
How Is the Trial Designed?
14Treatment groups
Experimental Treatment
Group I: Group 9 Arm CLOSEDExperimental Treatment1 Intervention
Group II: Group 8 - Arm CLOSEDExperimental Treatment1 Intervention
Group III: Group 7 - Arm CLOSEDExperimental Treatment1 Intervention
Group IV: Group 6 - Arm CLOSEDExperimental Treatment1 Intervention
Group V: Group 5 - Arm CLOSEDExperimental Treatment1 Intervention
Group VI: Group 4 - Arm CLOSED, no patients recruitedExperimental Treatment1 Intervention
Group VII: Group 3 - Arm CLOSEDExperimental Treatment1 Intervention
Group VIII: Group 2 - Arm CLOSED, no patients recruitedExperimental Treatment1 Intervention
Group IX: Group 14Experimental Treatment1 Intervention
Group X: Group 13 - Arm CLOSEDExperimental Treatment1 Intervention
Group XI: Group 12 - Arm CLOSEDExperimental Treatment1 Intervention
Group XII: Group 11 - Arm CLOSEDExperimental Treatment1 Intervention
Group XIII: Group 10 Arm CLOSEDExperimental Treatment1 Intervention
Group XIV: Group 1 - Arm CLOSED, no patients recruitedExperimental Treatment1 Intervention

Axitinib is already approved in European Union, United States, United Kingdom for the following indications:

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Approved in European Union as Inlyta for:
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Approved in United States as Inlyta for:
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Approved in United Kingdom as Inlyta for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials
135
Recruited
70,300+

Hoffmann-La Roche

Industry Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

AstraZeneca

Industry Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Seagen Inc.

Industry Sponsor

Trials
212
Recruited
73,800+
Founded
1997
Headquarters
Bothell, USA
Known For
Antibody-Drug Conjugates
Top Products
Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)
Dr. Roger Dansey profile image

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein profile image

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University

Published Research Related to This Trial

In a study of 170 patients with advanced non-squamous non-small-cell lung cancer, axitinib combined with pemetrexed and cisplatin showed a higher objective response rate (45.5% and 39.7%) compared to chemotherapy alone (26.3%).
While the combination therapy did not significantly improve progression-free survival compared to chemotherapy alone, it was generally well tolerated, with hypertension being the most common serious side effect in the axitinib groups.
Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer.Belani, CP., Yamamoto, N., Bondarenko, IM., et al.[2021]
Recent advancements in antibody therapies, such as monoclonal antibodies and bispecific T cell engagers, have made cancer treatments more effective while reducing toxicity, enhancing the safety profile of these therapies.
The discovery of immune checkpoints like PD1 and PD-L1 has transformed cancer immunotherapy, allowing for the development of immune checkpoint inhibitors that can effectively treat previously hard-to-treat cancers, such as stage IV lung cancer.
CAR-T "the living drugs", immune checkpoint inhibitors, and precision medicine: a new era of cancer therapy.Liu, D.[2023]
In a subgroup analysis of 94 Japanese patients with metastatic renal cell carcinoma, the combination of pembrolizumab and axitinib showed improved overall survival and progression-free survival compared to sunitinib, consistent with results from the larger global study.
The safety profile was also favorable, with fewer grade ≥3 treatment-related adverse events in the pembrolizumab-axitinib group (70%) compared to sunitinib (78%), and no deaths from treatment-related adverse events were reported.
Pembrolizumab plus axitinib versus sunitinib in metastatic renal cell carcinoma: outcomes of Japanese patients enrolled in the randomized, phase III, open-label KEYNOTE-426 study.Tamada, S., Kondoh, C., Matsubara, N., et al.[2022]

Citations

INLYTA® (axitinib) Clinical Trial Results | Safety Info70 of 361 patients taking INLYTA saw their tumors shrink compared to 34 of 362 patients taking Nexavar. This includes patients whose tumors shrank 30% or more ...
Axitinib: A Review of its Safety and Efficacy in the ...This paper reviews the mechanism of action of axitinib, its metabolism, and its pharmacokinetic profile. Clinical data of efficacy and safety is also detailed.
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36470258/
Real-World Study Evaluating Safety and Effectiveness of ...Axitinib dose reduction was required in 20% of the adverse events and discontinuation in 8%. Median progression-free survival was 12.4 months (95% confidence ...
Outcome after treatment with axitinib in children, young ...Similar to the KEYNOTE-426 trial, the combination of axitinib and avelumab led to a PFS of 13.9 months compared to 8.5 months with sunitinib (HR 0.67; 95 % CI ...
Real world experience with axitinib (Inlyta)The article suggests that the real world efficacy data for axitinib is similar to that seen in clinical trials, with a median overall survival of 16.4 months ...
Safety Profile For INLYTA® (axitinib) | 1st-LineHepatotoxicity (all grades) occurred in 39% of patients taking INLYTA in combination with pembrolizumab · Grade 3/4 hepatotoxicity occurred in 20% of patients ...
INLYTA® (axitinib) Important Safety InformationFind important safety information for INLYTA® (axitinib) for advanced RCC when 1 prior drug treatment regimen has not worked. See risks & benefits.
Inlyta (axitinib) tablets Label - accessdata.fda.govThe safety of INLYTA has been evaluated in 715 patients in monotherapy studies, which ... The population pharmacokinetic analysis pooled data from 17 trials in ...
Axitinib (oral route) - Side effects & dosageAxitinib is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are eventually destroyed. This ...
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