PF-07104091 monotherapy dose expansion (ovarian) for Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Small Cell Lung Cancer+4 MorePF-07104091 monotherapy dose expansion (ovarian) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new drug to see if it is safe and how well it works against different types of cancer.

Eligible Conditions
  • Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • Ovarian Cancer
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

6 Primary · 7 Secondary · Reporting Duration: From baseline and every 8 weeks through disease progression or study completion (approximately 2 years)

28 days
Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle
Day 28
Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07104091
Maximum plasma concentration (Cmax) of PF-07104091 after a single dose and multiple dose
Time to maximum plasma concentration (Tmax) of PF-07104091 after a single dose and multiple dose
Year 2
To document any preliminary evidence of antitumor activity of PF-07104091 as a single agen and in combination with palbociclib and in combination with letrozole by objective response rate (ORR) in dose escalation
Year 2
Letrozole
Year 2
Area under the curve of PF-07104091 with or without food
Maximum plasma concentration of PF-07104091 with or without food
To document any preliminary evidence of antitumor activity of PF-07104091 by time to event endpoints
Year 2
Evaluate blood pressure that is out of normal range and changes in blood pressure as compared to baseline
Evaluate pulse rate that is out of normal range and changes in pulse rate as compared to baseline
To evaluate heart rate corrected QT interval and changes in corrected QT interval as compared to baseline
To evaluate incidence of treatment emergent adverse events and laboratory abnormalities

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Trial Design

9 Treatment Groups

PF-07104091 + palbociclib + fulvestrant
1 of 9
PF-07104091
1 of 9
PF-07104091 monotherapy dose expansion (ovarian)
1 of 9
PF-07104091 + palbociclib + fulvestrant (CDK4/6 naive)
1 of 9
PF-07104091 monotherapy dose expansion (TNBC)
1 of 9
PF-07104091 + palbociclib + letrozole (CDK4/6 naive)
1 of 9
PF-07104091 + palbociclib + letrozole
1 of 9
PF-07104091 + palbociclib + fulvestrant (post CDK4/6)
1 of 9
PF-07104091 monotherapy dose expansion (SCLC)
1 of 9

Experimental Treatment

240 Total Participants · 9 Treatment Groups

Primary Treatment: PF-07104091 monotherapy dose expansion (ovarian) · No Placebo Group · Phase 2

PF-07104091 + palbociclib + fulvestrant
Drug
Experimental Group · 1 Intervention: PF-07104091 + palbociclib + fulvestrant · Intervention Types: Drug
PF-07104091
Drug
Experimental Group · 1 Intervention: PF-07104091 monotherapy dose escalation · Intervention Types: Drug
PF-07104091 monotherapy dose expansion (ovarian)
Drug
Experimental Group · 1 Intervention: PF-07104091 monotherapy dose expansion (ovarian) · Intervention Types: Drug
PF-07104091 + palbociclib + fulvestrant (CDK4/6 naive)
Drug
Experimental Group · 1 Intervention: PF-07104091 + palbociclib + fulvestrant (CDK4/6 naive) · Intervention Types: Drug
PF-07104091 monotherapy dose expansion (TNBC)
Drug
Experimental Group · 1 Intervention: PF-07104091 monotherapy dose expansion (TNBC) · Intervention Types: Drug
PF-07104091 + palbociclib + letrozole (CDK4/6 naive)
Drug
Experimental Group · 1 Intervention: PF-07104091 + palbociclib + letrozole (CDK4/6 naive) · Intervention Types: Drug
PF-07104091 + palbociclib + letrozole
Drug
Experimental Group · 1 Intervention: PF-07104091 + palbociclib + letrozole · Intervention Types: Drug
PF-07104091 + palbociclib + fulvestrant (post CDK4/6)
Drug
Experimental Group · 1 Intervention: PF-07104091 + palbociclib + fulvestrant (post CDK4/6) · Intervention Types: Drug
PF-07104091 monotherapy dose expansion (SCLC)
Drug
Experimental Group · 1 Intervention: PF-07104091 monotherapy dose expansion (SCLC) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline and every 8 weeks through disease progression or study completion (approximately 2 years)

Who is running the clinical trial?

PfizerLead Sponsor
4,310 Previous Clinical Trials
7,111,378 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,281 Previous Clinical Trials
4,820,649 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
were randomized in a 1:1:1 ratio to receive: Participants with HR-positive HER2-negative advanced or metastatic breast cancer (received at least two prior lines in the advanced or metastatic setting including one prior line of combined CDK4/6 inhibitor and endocrine therapy and no more than two prior lines of cytotoxic chemotherapy) were randomized in a 1:1:1 ratio to receive: The participants were randomly divided into three groups, each receiving a different type of treatment.
To make sure that the effects of any prior therapy are not still present, the acute effects will be resolved to baseline severity.
People who are joining the expansion cohort for the study must have at least one measurable lesion according to the RECIST version 1.1 guideline, which has not been previously irradiated.
A person with performance status 0 or 1 is completely unable to carry out usual activities
are needed for patients who are to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT)
People who have advanced or metastatic triple-negative breast cancer (TNBC) and have received up to 2 prior lines of chemotherapy in the advanced or metastatic setting are eligible to participate in this study.
You have HER2-negative advanced or metastatic breast cancer (second line plus setting).
You have cytological diagnosis of advanced/metastatic NSCLC.
You have cytological diagnosis of advanced/metastatic SCLC.