Rifampin + Divarasib for Drug Interaction Study

No longer recruiting at 1 trial location

Overseen By Reference Study ID Number: GP45718 https://forpatients.roche.com/

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Genentech, Inc.

Disqualifiers: Metabolic, Hepatic, Renal, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the interaction between two drugs, divarasib and rifampin, in healthy individuals. The goal is to understand how rifampin, an antibiotic, affects the movement and safety of divarasib in the body. Participants will first take divarasib alone, then with rifampin, to observe any changes. This trial suits individuals with a healthy medical history who fall within a certain weight range. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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. It's best to discuss this with the trial team or your doctor.

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

Research has shown that divarasib generally has a manageable safety profile. Studies have identified it as a treatment option for certain cancers, with most participants tolerating it well. The most common side effects included mild tiredness and nausea, which were neither severe nor life-threatening.

Rifampin, a medication used for many years primarily to treat bacterial infections like tuberculosis, has a well-known safety profile. Common side effects include upset stomach and skin rashes. This trial specifically examines how rifampin interacts with divarasib.

As an early-phase trial, the main goal is to assess how these drugs work together in the body and to evaluate their safety. Although much remains to be learned, early results are promising for the safety of both treatments when used separately. Participants should be aware that the combined effects are still under study. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Rifampin and Divarasib because it offers a fresh approach to drug interactions. Unlike standard treatments that individually target specific symptoms or conditions, this study looks at how Divarasib, a novel cancer drug, interacts with Rifampin, a well-known antibiotic used to treat infections like tuberculosis. The unique aspect here is understanding how these drugs influence each other's effectiveness and safety when used together, which could pave the way for safer and more effective combination therapies in the future. This trial is crucial because it explores potential synergies that could optimize treatment outcomes, particularly for patients needing both types of medication.

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

Research has shown that divarasib effectively treats various tumors with the KRAS G12C mutation. One study found that, when combined with cetuximab, a cancer treatment, it achieved a confirmed response rate of 62%. Other studies have found that divarasib performs comparably to other drugs targeting the same mutation, making it a promising option. In this trial, participants in Treatment A will receive a single oral dose of divarasib. Treatment B will explore the interaction between divarasib and rifampin, with participants receiving both drugs on specific days. Although specific data on divarasib's effectiveness with rifampin is lacking, studies are investigating their interaction in the body. This combination might enhance divarasib's effectiveness, but further research is needed to confirm this. ^{1 2 6 7 8}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy men and women who can't have children. Participants must have a body mass index (BMI) between 18.0 to 32.0 kg/m2.

Inclusion Criteria

My BMI is between 18.0 and 32.0.

I cannot become pregnant or get someone pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Period A

Participants receive a single oral dose of Divarasib on Day 1

1 day

1 visit (in-person)

Treatment Period B

Participants receive Rifampin once daily on Days 1 to 7 and Days 9 to 13, with Divarasib followed by Rifampin on Day 8

13 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Divarasib
• Rifampin

Trial Overview The study is testing how rifampin, an antibiotic, affects the levels and safety of divarasib, a new drug, in the bodies of healthy people.

How Is the Trial Designed?

Group I: Treatment B Experimental Treatment 2 Interventions

Participants will receive Rifampin once daily (QD) on Days 1 to 7 and Days 9 to 13. Participants will receive Divarasib followed by Rifampin on Day 8.

Group II: Treatment A Experimental Treatment 1 Intervention

Participants will receive a single oral dose of Divarasib on Day 1.

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2303810

Single-Agent Divarasib (GDC-6036) in Solid Tumors with a ... In this phase 1 study, treatment with divarasib resulted in clinical responses across tumor types with the KRAS G12C mutation.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05789082

NCT05789082 | A Study Evaluating the Safety, Activity, and ... The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of divarasib combined with other anti-cancer therapies in participants ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11111488/

Divarasib in the Evolving Landscape of KRAS G12C Inhibitors ... In recently reported phase I results, divarasib showed a similar efficacy as other KRAS G12C inhibitors.

4. cancernetwork.com cancernetwork.com/view/divarasib-combo-appears-promising-in-pretreated-kras-g12c-nsclc

Divarasib Combo Appears “Promising” in Pretreated KRAS ... The divarasib combination particularly demonstrated “promising” activity in a cohort of patients who received prior KRAS G12C inhibitors.

5. onclive.com onclive.com/view/divarasib-plus-cetuximab-demonstrates-promising-clinical-activity-and-manageable-safety-in-kras-g12c-mutant-crc

Divarasib Plus Cetuximab Demonstrates Promising ... Results from a phase 1b study (NCT04449874) demonstrated that patients (n = 29) experienced a confirmed overall response rate (ORR) of 62%.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05789082

NCT05789082 | A Study Evaluating the Safety, Activity, and ... The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of divarasib combined with other anti-cancer therapies.

7. go.drugbank.com go.drugbank.com/drugs/DB17488

Divarasib: Uses, Interactions, Mechanism of Action Access detailed drug and target data for your pharmaceutical research. ... Drug-Drug Interaction Checker · Drug Allergy · US Drug Labels · For ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00040

Single-Agent Divarasib in Patients With <i>KRAS G12C</i> Divarasib (GDC-6036), an oral, highly potent and selective next-generation KRAS G12C inhibitor, has demonstrated a manageable safety profile and promising ...