C2321001 Patient Summary – Metastatic Castration Resistant

This trial is no longer actively recruiting.

Prostate cancer is one of the most common types of cancer.  Unfortunately, prostate cancer can often become resistant to hormone therapy and continue to progress despite ongoing treatment.  When this occurs, it is called Castration Resistant Prostate Cancer (CRPC).

Patient Summary

The primary objective of this study is to evaluate if an investigational oral medicine is safe and effective for the treatment of metastatic castration resistant prostate cancer (mCRPC) and if it is effective in preventing further resistance to current standard-of-care medications for prostate cancer.  Participants may be eligible if they have been diagnosed with mCRPC that has progressed despite treatment with abiraterone.  In the study, patients will also receive Standard of Care (SoC) and supportive care.

What is the Purpose?

Pfizer C2321001 is a randomized, open-label, multi-center dose escalation and dose expansion study to evaluate if an PF-06821497, an investigational oral medicine, is safe and effective for the treatment of metastatic castration resistant prostate cancer (mCRPC). The information obtained from this study will assist in the design of future PF-06821497 clinical trials in patients with advanced prostate cancer.

What Type of Therapy is Used?

The investigational drug PF-06821497 is administered orally in adult patients in combination with an oral standard-of-care (SOC) treatment for mCRPC (enzalutamide).  Some participants are administered enzalutamide alone and may be eligible to add PF-06821497 to their regimen at the time of progression.

Who can Participate?

• Male adults ≥ 18 years of age
• Adults diagnosed with metastatic castration resistant prostate cancer that has progressed by PCWG3 criteria
• Participants must not have received prior treatment with enzalutamide, apalutamide or darolutamide.
• Participants must have received abiraterone in any setting
• Participants must not have completed more than 1 round of chemotherapy in any setting
• These are not the only eligibility criteria for this study

Some key exclusion criteria include:

• QTcF interval >480 msec at screening.
• Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy).
• Known or suspected hypersensitivity to PF-06821497 or any components or enzalutamide
• Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.

The above is not an exhaustive list, for further information or please speak to the study doctor.

What’s Involved?

Participants will receive:

• Participants will be randomly assigned in a 1:1 ratio to receive either enzalutamide (standard of care) or enzalutamide and the study medication.
• The oral investigational medication is a tablet taken twice a day for multiple 21-day cycles. Enzalutamide is an oral capsule taken once per day.
• Participants not initially assigned to receive the study drug will be given the option to begin taking the study medicine in addition to enzalutamide if their cancer is confirmed to have progressed during their time in the study.
• Participants may continue taking the study drug until disease progression or unacceptable toxicity occurs. Participants may remain in the study for as long as clinical benefit is demonstrated.
• Participants will need to attend regular visits during each treatment cycle as well as a follow-up 1-month post-treatment. These visits will include health assessments, questionnaires, blood samples, ECGs, CT/MRI scans, and biopsies.
• Participants will be asked to track their dose schedule in a diary.

Possible Patient Benefits:

There may be no direct benefit to you.

• Your prostate cancer and your health will be monitored regularly.
• The information gained from your participation in this study will contribute to the understanding of metastatic castration resistant prostate cancer.
• Your participation in this study may help others who have metastatic castration resistant prostate cancer in the future

Possible Patient Risks:

• The use of PF-06821497 investigational drug may provide no benefit for preventing disease progression in patients with metastatic castration resistant prostate cancer
• The use of PF-06821497 may also cause side effects

If you are interested in this trial, you can find additional information and see if you are eligible to participate at the links below:

Organization:

Pfizer

Clinicaltrials.gov Information:

• CT Number: NCT03460977
• Title: PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma

Use the “clinical trials glossary” and “dictionary” for words, phrases and treatments that you may not understand.

Register your interest or comments about this trial with PHEN

Please Note: This information is provided for educational and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.