Trial record 2 of 5 for:
pfizer | Recruiting, Not yet recruiting Studies | bladder cancer
A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03854227 |
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Recruitment Status :
Recruiting
First Posted : February 26, 2019
Last Update Posted : July 1, 2021
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Brief Summary:
This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Solid Tumors Metastatic Solid Tumors | Drug: PF-06939999 dose escalation Drug: PF-06939999 monotherapy Drug: PF-06939999 in combination with docetaxel | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 140 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | Dose Escalation |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06939999 (PRMT5 INHIBITOR) IN PARTICIPANTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER, HEAD AND NECK SQUAMOUS CELL CARCINOMA, ESOPHAGEAL CANCER, ENDOMETRIAL CANCER, CERVICAL CANCER AND BLADDER CANCER |
| Actual Study Start Date : | March 14, 2019 |
| Estimated Primary Completion Date : | October 13, 2024 |
| Estimated Study Completion Date : | April 14, 2026 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Dose Escalation
Participants will receive PF-06939999 orally at escalating doses in 28 day cycles on a continuous basis
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Drug: PF-06939999 dose escalation
PF-06939999 orally at escalating doses on a continuous basis
Other Name: PRMT5 inhibitor |
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Experimental: Non small cell lung cancer monotherapy
Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
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Drug: PF-06939999 monotherapy
PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
Other Name: PRMT5 inhibitor |
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Experimental: Urothelial carcinoma
Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
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Drug: PF-06939999 monotherapy
PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
Other Name: PRMT5 inhibitor |
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Experimental: Head and neck squamous cell carcinoma
Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
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Drug: PF-06939999 monotherapy
PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
Other Name: PRMT5 inhibitor |
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Experimental: Non small cell lung cancer PF-06939999 plus docetaxel
Participants will receive PF-06939999 on a continuous basis in combination with docetaxel
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Drug: PF-06939999 in combination with docetaxel
PF-06939999 orally on a continuous basis in combination with docetaxel
Other Name: PRMT5 inhibitor |
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Experimental: Non small cell lung cancer dose finding
Participants will receive PF-06939999 on a continuous basis at escalating doses in combination with docetaxel
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Drug: PF-06939999 in combination with docetaxel
PF-06939999 orally on a continuous basis in combination with docetaxel
Other Name: PRMT5 inhibitor |
Primary Outcome Measures :
- Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Baseline through day 28 ]DLTs will be evaluated during the first cycle. The number of DLTs will be used to determine the maximum tolerated dose (MTD)
- Number of participants with treatment emergent adverse events (AEs) [ Time Frame: Baseline through up to 2 years or until disease progression ]Adverse events as characterized by type, frequency, severity, timing, seriousness and relationship to study therapy
- Number of participants with laboratory abnormalities [ Time Frame: Baseline through up to 2 years or until disease progression ]Laboratory abnormalities as characterized by type, frequency, severity, and timing.
- Objective Response Rate [ Time Frame: Baseline through up to 2 years or until disease progression ]Best Overall Response by RECIST 1.1
Secondary Outcome Measures :
- Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24 ]Single dose PK will be calculated including Maximum Observed Plasma Concentration (Cmax).
- Pharmacokinetic Parameters: Time to reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24 ]Single dose PK will be calculated including Time to reach Maximum Observed Plasma Concentration (Tmax).
- Pharmacokinetic Parameters: Area Under the Curve from time 0 to the last sampling time point within the dose interval (AUClast) [ Time Frame: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24 ]Single dose PK will be calculated including Area Under the Curve from time 0 to the last sampling time point within the dose interval (AUClast)
- Pharmacokinetic Parameters: Terminal elimination half life (t1/2) [ Time Frame: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24 ]Single dose PK will be calculated including, as data permit, terminal elimination half life (t1/2)
- Pharmacokinetic Parameters: AUC from time 0 extrapolated to infinity (AUCinf) [ Time Frame: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24 ]Single dose PK will be calculated including, as data permit, Area Under the Curve from time 0 extrapolated to infinity (AUCinf)
- Pharmacokinetic Parameters: Apparent oral plasma clearance (CL/F) [ Time Frame: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24 ]Single dose PK will be calculated including, as data permit, apparent oral plasma clearance (CL/F)
- Pharmacokinetic Parameters: Apparent volume of distribution (Vz/F) [ Time Frame: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24 ]Single dose PK will be calculated including, as data permit, apparent volume of distribution (Vz/F)
- Pharmacokinetic Parameters: Maximum Observed Steady State Plasma Concentration (Css,max) [ Time Frame: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24 ]Multiple dose PK will be calculated including Maximum Observed Steady State Plasma Concentration (Css,max).
- Pharmacokinetic Parameters: Time to reach Maximum Observed Steady State Plasma Concentration (Tss,max) [ Time Frame: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24 ]Multiple dose PK will be calculated including Time to reach Maximum Observed Steady State Plasma Concentration (Tss,max).
- Pharmacokinetic Parameters: Area Under the Curve within one dose interval (AUCss,t) [ Time Frame: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24 ]Multiple dose PK will be calculated including Area Under the Curve within one dose interval (AUCss,t)
- Pharmacokinetic Parameters: Steady state apparent oral plasma clearance (CL/F) [ Time Frame: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8. 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24 ]Multiple dose PK will be calculated including, as data permit, steady state apparent oral plasma clearance (CL/F)
- Pharmacokinetic Parameters: Steady state apparent volume of distribution (Vss/F) [ Time Frame: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24 ]Multiple dose PK will be calculated including, as data permit, steady state apparent volume of distribution (Vss/F)
- Pharmacokinetic Parameters: Accumulation ratio (Rac) [ Time Frame: Cycle 1 Days 1 and 15, predose, 0.5, 1, 2, 4, 6 and 12 hours post dose; predose on Cycle 1 Days 2, 8, 16 and 22 and predose on Day 1 of every Cycle (each cycle is 28 days) thereafter until month 24 ]Multiple dose PK will be calculated including, as data permit, accumulation ratio (Rac)
- Duration of response (DOR) [ Time Frame: Baseline through up to 2 years or until disease progression ]DOR as assessed using RECIST 1.1
- Progression free survival (PFS) [ Time Frame: Baseline through up to 2 years or until disease progression ]PFS as assessed using RECIST 1.1.
- Time to progression (TTP) [ Time Frame: Baseline through up to 2 years or until disease progression ]TTP as assessed using RECIST 1.1.
- Overall Survival (OS) [ Time Frame: Baseline through up to 2 years ]Proportion of participants alive at 6 months, 1 year and 2 years.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC, urothelial carcinoma or HNSCC
- Progressed after at least 1 line of treatment and no more than 3 lines of treatment
- At least one measurable lesion as defined by RECIST version 1.1
- ECOG Performance Status 0 or 1
- Adequate Bone Marrow Function
- Adequate Renal Function
- Adequate Liver Function
- Resolved acute effects of any prior therapy
Exclusion Criteria:
- Known active uncontrolled or symptomatic CNS metastases.
- Major surgery, radiation therapy, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry.
- Active, uncontrolled infection, including COVID-19
- Known or suspected hypersensitivity to PF-06939999
- Inability to consume or absorb study drug
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854227
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Locations
Show 42 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT03854227 |
| Other Study ID Numbers: |
C3851001 |
| First Posted: | February 26, 2019 Key Record Dates |
| Last Update Posted: | July 1, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Neoplasms Docetaxel Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |