A Phase 1 interventional study of Poziotinib and T-DM1 in Breast Cancer, sponsored by Spectrum Pharmaceuticals, Inc. Terminated at 2 sites in United States. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-01-15.
Sponsored by Spectrum Pharmaceuticals, Inc (part of Zydus Lifesciences Limited) · Phase 1, Interventional, and Treatment
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Among 10 studies in Breast Neoplasms by Zydus Lifesciences Limited — none open to participants now, none under way, none of them phase 3. Breast Neoplasms · Zydus Lifesciences Limited.
Among the 10 studies in Breast Neoplasms by Zydus Lifesciences Limited, this one is the 9th largest by enrollment, is one of 2 that started in 2018, is one of 3 in phase 1, and was the 6th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →None of the 10 studies in Breast Neoplasms by Zydus Lifesciences Limited is open now. The open studies under Breast Neoplasms, anywhere →
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years to 90 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 is below the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 63 across the 10 interventional studies. Of the 10 that completed or were terminated, 5 (50%) have results posted.
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This study is registered under Spectrum Pharmaceuticals, Inc, one of the names counted as Zydus Lifesciences Limited. Under that name alone:
Spectrum Pharmaceuticals, Inc is the lead sponsor of 60 studies on the registry; 1 is open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 12 (67%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Breast Neoplasms by Zydus Lifesciences Limited, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a Phase 1b, open-label, multicenter study to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of poziotinib when administered with standard dosing of T-DM1 (3.6 mg/kg IV on Day 1 of each 21-day cycle) in women with advanced or metastatic HER2+ breast cancer. The poziotinib dose identified in Part 1 of the study will be used in combination with standard dose of T-DM1 in Part 2 of the study to confirm the poziotinib dose and evaluate the preliminary efficacy of the combination therapy.
In Part 1, the dose of poziotinib, in combination with the standard dose of T-DM1 (3.6 mg/kg IV) on Day 1 of each cycle will be determined using a "3+3" design with up to 3 dose levels tested beginning with 8 mg/day.
Poziotinib dose escalation/de-escalation for the next dose cohort will proceed based on the occurrence of dose-limiting toxicities (DLTs) during Cycle 1 of the dose cohort. Patients in the dose cohort, if not discontinued, will continue treatment until discontinuation.
In Part 2 of the study, approximately 10 patients will be treated at the MTD/MAD to confirm dose for safety of the combination and to evaluate preliminary efficacy. Treatment for all patients will continue until disease progression, unacceptable toxicity, or continuation of study treatment is not in the best interest of the patient.
The Screening period (Day -30 to Day -1) will last up to 30 days prior to Cycle 1, Day 1.
During each 21-day cycle, eligible patients will receive poziotinib at the assigned dose, orally, once daily. T-DM1 3.6 mg/kg IV will be administered on Day 1 of each treatment cycle.
All treated patients will be followed for response until disease progression or the start of new treatment and then for survival (3 year study duration).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Part 1: Dose Finding The MTD/MAD of poziotinib in combination with the standard dose of T-DM1 will be determined by using a "3+3" design. At least 3 patients may be enrolled in each cohort before a decision is made to proceed to the next cohort. * Part 2: MTD/MAD Expansion An additional 10 patients will be treated at the dose identified during Part 1 to further evaluate the combination at the MTD or the MAD.
Drug: Poziotinib · Drug: T-DM1
Poziotinib is a tablet for oral administration.
T-DM1 (ado-trastuzumab emtansine) is a HER2-targeted therapy for I.V. administration.
Also known as: ado-trastuzumab emtansine
Objective Response Rate (ORR)
Evaluate the Objective Response Rate (ORR) in patients treated with daily poziotinib in combination with T-DM1 (every 3 weeks) in women with advanced or metastatic HER2 positive breast cancer.
Time frame: 3 Years
Disease Control Rate (DCR)
Evaluate the Disease Control Rate (DCR) at 9, 18, and 27 weeks in patients treated at the MTD/MAD.
Time frame: 27 weeks
Progression-free Survival (PFS)
Evaluate Progression-free Survival (PFS) in patients treated with MTD/MAD.
Time frame: 3 years
Ran from Jul 2018 to primary completion in Apr 2019, 9 months.
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This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Poziotinib
Spectrum Pharmaceuticals, Inc →