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Non-metastatic Breast CancerPhase 2NCT02650193

A Study Of The Safety And Effects Of One Or More Doses Of HSP-130 Injected Under The Skin In Women With Breast Cancer That Has Not Spread To Distant Sites In The Body.

A Phase 2 study testing HSP-130 in people with Non-metastatic Breast Cancer, run by Pfizer at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a study of how one or more injections of HSP-130 under the skin effect the white blood cell counts and drug levels in women with breast cancer that has not spread to distant sites in the body (non-metastatic). This will be studied in women before breast surgery or while receiving chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Non-metastatic Breast Cancer
What is being tested?
HSP-130
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
7 sitesin 2 countries
Study dates
Dec 2015to Oct 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A subject will be eligible for study participation if all of the following criteria are met at Screening:
  • Is informed, has been given ample time and opportunity to read about participation in the study and has signed and dated the written informed consent form approved by an Independent Ethics committee (IEC) prior to any study related activities
  • Females ≥ 18 years
  • Histologically confirmed and documented invasive breast cancer
  • Breast cancer without evidence of distant metastases (Stage 4) based on staging work-up
  • Chemotherapy naive, who have not received chemotherapy in the neoadjuvant setting and who are candidates for chemotherapy in the adjuvant setting of taxane/cyclophosphamide-based regimen, e.g., TAC, as background chemotherapy
Show all 22Show fewer
  • Zubrod/WHO/ECOG performance status ≤ 2
  • Adequate bone marrow, hepatic, and renal function reserve as evidenced by:
  • Hemoglobin ≥ 10 mg/dl
  • ANC ≥ 1.5 x 10^9/L
  • Platelet count of ≥ 100 x 10^9/L
  • Total bilirubin ≤ 2 mg/dl
  • Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 x the upper limit of normal (ULN) of the reference lab
  • Serum creatinine of ≤ 1.5 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of ≥ 60 mg/min
  • Body mass index (BMI) of 19 to 40 kg/m^2 , inclusive
  • Subjects of childbearing potential, and their partners, agree to pregnancy prevention throughout the duration of the study (through the Follow-up Visit). Specific type of pregnancy prevention should be discussed with, and acceptable to, the treating oncologist in the context of the tumoral hormone receptor status. Subjects and their partners must agree to use of an effective method of contraception, to avoid impregnation of females throughout the course of the study
  • Medically acceptable forms of birth control can include, with approval of the treating physician:
  • Barrier methods (condom or diaphragm with spermicide)
  • Intrauterine device (IUD)
  • Hormone contraceptives (such as oral [pill], injection, skin patch, implant, cervical ring)
  • Subjects using oral contraceptives must be on a stable regimen for at least 3 months prior to Screening. Sexually active subjects must use contraception while on HSP-130 from admission to the final Follow-up Visit
  • Able to understand verbal or written instructions and comply with all study requirements, to communicate effectively with study personnel and is available for the planned duration of the study

Who cannot join

  • A subject will NOT be eligible for study participation if any of the following criteria are met at Screening:
  • Previous G-CSF exposure, including filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim, granulocyte/macrophage colony stimulating growth factor (GM-CSF), or any other branded or biosimilar G-CSF
  • Prior autologous stem cell harvest of any type
  • Drug sensitivity, allergic reaction, or known hypersensitivity or idiosyncratic reaction to E. coli - derived proteins, filgrastim, other G-CSFs, or pegylated agents
  • Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin
  • For subjects receiving doxorubicin, no concurrent use of inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp or with trastuzumab due to increased risk of cardiac dysfunction
Show all 21Show fewer
  • Chemotherapy other than that included in this study (taxane/cyclophosphamide-based regimen, e.g., TAC or TC) or neoadjuvant chemotherapy; or known immunosuppressive agents including chronic oral corticosteroid use, or radiation therapy within 4 weeks of first dose of HSP-130, prior bone marrow or stem cell transplantation, or malignancy within 5 years
  • Known HER2 + ( overexpressing breast cancer)
  • Known triple negative (estrogen receptor-negative, progesterone receptor-negative and HER2-negative) breast cancer
  • ≥ Grade 2 underlying neuropathy
  • Current diagnosis of active tuberculosis or other severe infection, such as sepsis, abscesses or opportunistic infections
  • Treatment with systemically active antibiotics within 72 hours before chemotherapy
  • Known infection with HIV
  • Known sickle cell disease
  • Known severe persistent drug-induced myelosuppression
  • New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina, clinically significant ECG abnormalities) or MI within the previous 6 months before the first administration of HSP-130
  • Any malignancy other than breast cancer, with exception of adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ, within 5 years before the first administration of the HSP-130
  • Current or recent treatment (within 30 days before the first administration of the HSP-130) with any other investigational medicinal product
  • Pregnancy or lactation; Subjects planning to be pregnant or to breastfeed before, during, or within 12 months after administration of the HSP-130 are not permitted to enroll in the study
  • Received a live, live-attenuated, or non-live vaccine within 4 weeks before the first administration of the HSP-130
  • Patient has evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding or clinical lab finding giving reasonable suspicion of a disease or condition that contraindicated the use of an HSP-130, or patient is high risk for treatment complication

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Spain4 sites

  • Hospital Universitario de Fuenlabrada, Servicio de oncologia

    Fuenlanbrada, Madrid, 28942

  • Hospital Universitario Arnau de Vilanova

    Lleida, Catalonia, 25198

  • START Madrid - CIOCC, Unidad de fases 1 planta 3, Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Arnau de Vilanova. planta 6, unidad de Oncología

    Valencia, 46015

Other trials in Spain

Hungary3 sites

  • Országos Onkológiai Intézet

    Budapest, 1122

  • Debreceni Egyetem Klinikai Központ, ÁOK, Onkológiai Klinika

    Debrecen, Hajdú-bihar Megye, 4032

  • CRU Hungary Kft.,CRU Early Phase Unit, Miskolci Semmelweis Kórház és Egyetemi Oktató Kórház

    Miskolc, BAZ Megye, 3529

Other trials in Hungary

About this study

Official title: A Phase 1-2 Ascending Dose Study To Assess The Pharmacodynamics, Pharmacokinetics, And Safety Of Hsp-130 In Subjects With Non-metastatic Breast Cancer Following Single-dose And Multiple-dose Administration By Subcutaneous Injection

This is a study of how one or more injections of HSP-130 under the skin effect the white blood cell counts and drug levels in women with breast cancer that has not spread to distant sites in the body (non-metastatic). This will be studied in women before breast surgery or while receiving chemotherapy. Safety will also be studied.

Additionally, the purpose of this study is to evaluate the effects and safety of single and multiple doses of HSP-130 in subjects with non-metastatic breast cancer. This study will determine the dose to move forward for future clinical trials.

Read the detailed description

This is an open-label, sequential enrollment study characterizing the pharmacodynamic (PD), pharmacokinetic (PK) and safety of HSP-130 in subjects with non-metastatic breast cancer who have not previously received chemotherapy at any point prior to enrollment in this study (ZIN-130-1504).

The purpose of this study is to evaluate the effects and safety of single and multiple doses of HSP-130 in subjects with non-metastatic breast cancer. This study will determine the dose to move forward for future clinical trials.

There are two aspects of the study. In the initial part of the study, 6 subjects will be sequentially enrolled to receive HSP-130 treatment (3 mg , or 6 mg by subcutaneous injection) during the period between biopsy and definitive surgery. This will determine whether 3 mg and 6 mg have similar or different effects on the PD variables (absolute neutrophil counts and CD34+ cell counts). This part of the study is referred to as Cycle 0 since study subjects will receive no chemotherapy while receiving HSP-130 until the effect of HSP-130 on the PD variables is known. A total of 12 subjects may be enrolled in Cycle 0.

The objective of Cycle 1-4 is to determine the dose to be taken forward to Phase 3 clinical trials. Cycles 1-4 subjects will receive HSP-130 after their definitive breast surgery at the time they receive TAC chemotherapy (docetaxel, doxorubicin, and cyclophosphamide). Subjects will receive up to 4 cycles of every 3 week TAC chemotherapy with HSP-130 given on Day 2 of the chemotherapy regimen.

  • If the 3 mg dose is found to be inferior (potentially subtherapeutic) to the 6 mg dose in Cycle 0, only the 6 mg dose will be studied in Cycles 1-4 (n=12), when subjects receive concomitant chemotherapy.
  • If the 3 mg dose is found to be comparable to the PD results obtained in Cycle 0 with 6 mg, the 3 mg dose (n=12) will also be studied in women receiving TAC chemotherapy.

Data from the HSP-130 6 mg regimen (plus 3 mg, as appropriate) will be analysed, discussed with the FDA and determination if a dose greater than 6 mg is appropriate to study (e.g., 12 mg). If all three doses are studied, a total enrollment of up to 36 subjects is projected for Cycles 1-4.

Being tested
HSP-130
Keywords
HSP-130 Phase 1-2 Study in patients with Breast cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSP-130Drug

    Also called Pegylated filgrastim

    Dosage will vary per each cohort: (Five independent cohorts) Cycle 0 Regimen A - 3 mg Cycle 0 Regimen B - 6 mg Cycles 1-4 Regimen B - 6 mg Cycles 1-4 Regimen A (Potential)- 3 mg Cycles 1-4 Regimen C (Conditional)- 12 mg

Study groups in NCT02650193
Study groupRoleWhat they receive
HSP-130ExperimentalCycle 0: Regimen A: HSP 130, 3 mg, single SC injection in the deltoid region (n = 6) Regimen B: HSP 130, 6 mg, single SC injection in the deltoid region (n = 6) Cycles 1-4: Regimen B (n = 12): HSP 130, 6 mg, single SC injection in the deltoid region, at least 24 hours after administration of chemotherapy in Cycle 1, Cycle 2, Cycle 3, and Cycle 4. Potential Regimen A (n = 12): 3 mg with background chemotherapy: Inclusion of this cohort will be based on assessment of comparability between Regimens A and B in Cycle 0 for ANC and CD34+ as defined above. If performed, this regimen will be HSP 130, 3 mg, single SC injection in the deltoid region, at least 24 hours after administration of chemotherapy in Cycle 1, Cycle 2, Cycle 3, and Cycle 4, as appropriate. Conditional Regimen C (12 mg):This cohort will not be initiated until data from cycle 0 for 3 mg and 6 mg and Cycles 1-4 for 6 mg has been reviewed and analyzed.
Receives: Drug: HSP-130

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Effect Curve for Absolute Neutrophil Count (AUECANC): Cycle 0

    Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

    Measured: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

  2. Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0

    AUCinf = Area under the serum concentration of HSP-130 versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf).

    Measured: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  3. Maximum Observed Serum Concentration (Cmax): Cycle 0

    Measured: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  4. Duration of Severe Neutropenia (DSN): Cycle 1

    Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9 per liter. DSN was defined as the days with grade 4 neutropenia (ANC < 0.5 x10^9/L).

    Measured: Cycle 1: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

  5. Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4

    AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).

    Measured: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  6. Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4

    Measured: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Secondary outcomes (31)

  1. Maximum Effect for Absolute Neutrophil Count (ANC_Emax): Cycle 0

    ANC was a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

    Measured: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

  2. Time of Maximum Effect for Absolute Neutrophil Count (ANC_Tmax): Cycle 0

    ANC was a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

    Measured: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

  3. Area Under the Effect Curve for CD34+ (AUECCD34+): Cycle 0

    Measured: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

  4. Maximum Effect for CD34+ Count (CD34+_Emax): Cycle 0

    Measured: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

  5. Time of Maximum Effect for CD34+ Count (CD34+ Tmax): Cycle 0

    Measured: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

  6. Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 0

    ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

    Measured: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

  7. Area Under the Effect Curve From Time of Dose Administration to Time Infinity for CD34 + (AUEC_CD34+ Inf): Cycle 0

    Measured: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

  8. Area Under the Serum Concentration Time Curve From the Time of Dose Administration to the Time of Last Measurable Concentration (AUCt): Cycle 0

    AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).

    Measured: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  9. Time To Achieve Maximum Serum Concentration (Tmax): Cycle 0

    Measured: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  10. Elimination Half-Life (t1/2): Cycle 0

    t1/2 is the time taken for plasma concentration of HSP 130 to reduce by 50 percent (%) of its initial value.

    Measured: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  11. Elimination Rate Constant (λz): Cycle 0

    Elimination rate constant was defined as the rate at which the drug was removed from the body.

    Measured: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  12. Apparent Clearance (CL/F): Cycle 0

    Clearance of a drug was defined as the rate at which a drug was metabolized or eliminated by normal biological processes.

    Measured: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  13. Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0

    The protein-content correction was conducted for AUCinf parameter: Protein-content corrected AUCinf = Nominal Protein-content AUCinf / (Actual protein concentration/10.0 mg/mL).

    Measured: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  14. Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 0

    The protein-content correction was conducted for AUCt parameter: Protein-content corrected AUCt= Nominal Protein-content AUCt / (Actual protein concentration/10.0 mg/mL).

    Measured: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  15. Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 0

    The protein-content correction was conducted for Cmax parameter: Protein-content corrected Cmax = Nominal Protein-content Cmax / (Actual protein concentration/10.0 mg/mL).

    Measured: Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  16. Duration of Severe Neutropenia (DSN): Cycle 4

    Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9/L. DSN was defined as the days with grade 4 neutropenia (ANC < 0.5 x10^9/L).

    Measured: Cycle 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

  17. Absolute Neutrophil Count Nadir Concentration: Cycle 1 and Cycle 4

    Nadir was defined as the lowest count for ANC concentration reported after first dose of study treatment.

    Measured: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose

  18. Time of ANC Nadir Concentration: Cycle 1 and Cycle 4

    Time of ANC Nadir (in hours) was defined as the time from the first dose of study treatment on Day 2 of Cycle 1 and 4 to the time the lowest value was recorded.

    Measured: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose

  19. Area Under the Effect Curve (AUEC_ANCt): Cycle 1 and Cycle 4

    ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

    Measured: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose

  20. Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 1 and Cycle 4

    Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.

    Measured: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

  21. Incidence of Febrile Neutropenia: Cycle 1 and Cycle 4

    Febrile Neutropenia was defined as tympanic or axillary body temperature greater than (>) 38.5 °C for >1 hour and ANC less than (<) 1.0 *10^9/L.

    Measured: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

  22. Incidence of Severe Neutropenia: Cycle 1 and Cycle 4

    Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9/L.

    Measured: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose

  23. Time to ANC Recovery: Cycle 1 and Cycle 4

    Time to ANC recovery was defined as the time from documentation of the first day with ANC greater than equal to (>=) 2.0 x10^9/L after any day with ANC <2.0 x10^9/L.

    Measured: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose

  24. Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4

    AUC0-inf = Area under the serum concentration versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf).

    Measured: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  25. Time To Achieve Maximum Serum Concentration (Tmax): Cycle 1 and Cycle 4

    Measured: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  26. Elimination Half-Life (t1/2): Cycle 1 and Cycle 4

    t1/2 is the time taken for plasma concentration of a drug to reduce by 50% of its initial value.

    Measured: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  27. Elimination Rate Constant (λz): Cycle 1 and Cycle 4

    Elimination rate constant was defined as the rate at which the drug was removed from the body.

    Measured: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  28. Apparent Clearance (CL/F): Cycle 1 and Cycle 4

    CL/F was defined as a quantitative measure of the rate at which a drug substance is removed from the body.

    Measured: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  29. Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4

    The protein-content correction was conducted for AUCt parameter: Protein-content corrected AUCt= Nominal Protein-content AUCt / (Actual protein concentration/10.0 mg/mL).

    Measured: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  30. Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4

    The protein-content correction was conducted for AUCinf parameter: Protein-content corrected AUCinf = Nominal Protein-content AUCinf / (Actual protein concentration/10.0 mg/mL).

    Measured: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

  31. Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4

    The protein-content correction was conducted for Cmax parameter: Protein-content corrected Cmax = Nominal Protein-content Cmax / (Actual protein concentration/10.0 mg/mL).

    Measured: Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionOct 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02650193
Sponsor's protocol ID
ZIN-130-1504
Other IDs
C1221002, 2015-002057-35, 2015
Status last verified
Sep 2018
First submitted
4 Jan 2016
Last updated
23 Oct 2018
Data monitoring committee
No

Publications

  • Yao HM, Jones SR, Morales S, Moosavi S, Zhang J, Freyman A, Ottery FD. Phase I/II study to assess the clinical pharmacology and safety of single ascending and multiple subcutaneous doses of PF-06881894 in women with non-distantly metastatic breast cancer. Cancer Chemother Pharmacol. 2021 Dec;88(6):1033-1048. doi: 10.1007/s00280-021-04355-6. Epub 2021 Oct 7.

    PubMed 34618197

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HSP-130 in people with Non-metastatic Breast Cancer, run by Pfizer at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Effect Curve for Absolute Neutrophil Count (AUECANC): Cycle 0 (time frame: Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02650193, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.

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