Axitinib for Renal Cell Carcinoma

(PADRES Trial)

Not currently recruiting at 1 trial location

Overseen By William Brocklehurst

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Diego

Must be taking: Axitinib

Disqualifiers: Metastatic disease, Non-clear cell histology, Prior RCC treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8-10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests axitinib, a medication, to determine if it can shrink kidney tumors in patients with localized clear cell renal carcinoma (a type of kidney cancer). The goal is to enable partial nephrectomy (a kidney-sparing surgery) for those currently unable to undergo it due to the tumor's size or location. Suitable candidates for this trial include individuals with clear cell renal carcinoma who require kidney-sparing surgery but cannot have it yet due to tumor complexity or kidney function issues. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have uncontrolled hypertension or need more than three blood pressure medications, you may not be eligible to participate.

Is there any evidence suggesting that axitinib is likely to be safe for humans?

Research has shown that axitinib is safe and effective in treating renal cell carcinoma, a type of kidney cancer. In previous studies, axitinib was associated with some side effects. For instance, 83% of patients in one study experienced side effects, most of which were related to the drug. However, the FDA has approved axitinib for treating advanced kidney cancer, indicating that its safety is generally well understood and manageable. Prospective trial participants should discuss possible side effects with a healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for renal cell carcinoma?

Axitinib is unique because it specifically targets vascular endothelial growth factor receptors (VEGFR), which play a crucial role in the blood supply to tumors. Unlike many standard treatments for renal cell carcinoma, which may have broader mechanisms, axitinib's precise action can potentially result in fewer side effects and more effective tumor shrinkage. Researchers are excited about axitinib because its targeted approach may offer improved outcomes for patients, particularly those who have not responded well to other therapies.

What evidence suggests that axitinib might be an effective treatment for renal cell carcinoma?

Research has shown that axitinib, which participants in this trial will receive, can help shrink tumors in people with kidney cancer. In one study, about 19% of patients taking axitinib experienced significant tumor shrinkage, compared to 9% of patients taking a different cancer drug. Another study found that 27% of patients had smaller tumors, and 41% maintained stable disease, preventing progression. These findings suggest that axitinib can help control tumor size and growth, which is important for patients considering complex surgeries like partial nephrectomy. ^{2 6 7 8 9}

Who Is on the Research Team?

Ithaar H Derweesh, MD

Principal Investigator

UC San Diego Moores Cancer Center

Brian I Rini, MD

Principal Investigator

Vanderbilt-Ingram Cancer Center

Steven C Campbell, MD, PhD

Principal Investigator

The Cleveland Clinic

Ithaar H Derweesh, MD

Principal Investigator

UC San Diego Moores Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with localized clear cell renal carcinoma who can't have partial nephrectomy due to anatomical challenges or concerns about remaining kidney function. They should not have distant metastases, must need kidney-sparing surgery, and may already have some level of chronic kidney disease.

Inclusion Criteria

Hemoglobin ≥9.0 g/dL

Absolute neutrophil count (ANC) ≥1,000/μL

Platelets ≥100,000/μL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive axitinib 5 mg PO BID for 8-10 weeks to evaluate tumor downsizing and facilitate partial nephrectomy

8-10 weeks

Surgery

Feasibility of partial nephrectomy is assessed, with the goal of achieving successful surgery with negative margins

1 week

Follow-up

Participants are monitored for safety, tumor response, and renal function outcomes post-treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Axitinib

Trial Overview The study tests if taking Axitinib (Inlyta) before surgery can make complex kidney-sparing surgeries more doable by shrinking the tumor. It's a phase II trial involving 50 participants to see if this approach is safe and effective.

How Is the Trial Designed?

Group I: Axitinib Oral Tablet [Inlyta] Experimental Treatment 1 Intervention

Axitinib 5 mg PO BID for 8-10 weeks

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Citations

1. inlyta.com inlyta.com/axitinib/clinical-trial-results

INLYTA® (axitinib) Clinical Trial Results | Safety Info 70 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7265645/

Axitinib as a third or further line of treatment in renal cancer The majority of patients (13/68%) had clinical benefit from axitinib therapy resulting in 6 (27%) partial responses and 9 (41%) stabilizations of disease by ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11376413/

Real-world experience of second-line axitinib in metastatic ... The median OS (95% CI) for all patients who received second-line axitinib was 12.2 (7.7–14.2) months; 28 (25.5%) patients remained censored at the time of ...

4. actionkidneycancer.org actionkidneycancer.org/real-world-experience-with-axitinib-inlyta/

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 ...

5. keytruda.com keytruda.com/kidney-cancer/combination-therapy-clinical-trial-results/

Results from a clinical trial of KEYTRUDA + axitinib Half of the patients receiving KEYTRUDA with axitinib were alive without their cancer spreading, growing, or getting worse at 15 months, compared to 11 months ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3825605/

Axitinib: A Review of its Safety and Efficacy in the ... This agent has demonstrated promising activity in phase II trials for the treatment of various solid tumors in addition to RCC, including metastatic melanoma, ...

7. e-crt.org e-crt.org/journal/view.php?number=3426

Real-World Study Evaluating Safety and Effectiveness of ... Ninety-two patients (83%) experienced 338 adverse events, 71% (264/338) of which were evaluated to be related to axitinib.

8. inlyta.com inlyta.com/

INLYTA® (axitinib) Home Page | Safety Info INLYTA is a prescription medicine used to treat kidney cancer that has spread or cannot be removed by surgery (advanced renal cell carcinoma or RCC)

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078143923002867

Efficacy and safety of axitinib for metastatic renal cell ... Limited information is currently available on the efficacy and safety of axitinib for metastatic renal cell carcinoma (mRCC) patients with renal impairment.