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NCT01976169 · ClinicalTrials.gov registry record · Phase 1
Phase 1b Study of PD-0332991 in Combination With T-DM1(Trastuzumab-DM1)
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT01976169: Completed Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT01976169 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01976169, a Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
Standard of care: Treatment with Trastuzumab Experimental: 21-Day Cycle of Combination therapy with T-DM1 intravenously on Day 1 and oral PD-0332991 on Days 5-18 Study Design and Methodology: This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with T-DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior trastuzumab or other HER2-directed therapies. The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how well the subject tolerates the treatment. A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle. Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral) Cohort 3 : PD-0332991 - 200 mg daily (oral) The 3+3 design entails that if one patient out of the first three patients has a DLT, up to three additional patients will be entered at that dose level Treatment cycles will continue until disease progression or withdrawal from study.
Primary Outcome
A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle. Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral) Cohort 3 : PD-0332991 - 200 mg daily (oral)
Interventions
- DRUG PD-0332991 and T-DM1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2014-01-24 |
| Est. Completion | 2021-05-19 |
| Phase | Phase 1 |
What the finished NCT01976169 record still lists
NCT01976169 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which PD-0332991 and T-DM1 is the first listed.
NCT01976169 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01976169 about?
NCT01976169 is a clinical study titled "Phase 1b Study of PD-0332991 in Combination With T-DM1(Trastuzumab-DM1)". Standard of care: Treatment with Trastuzumab Experimental: 21-Day Cycle of Combination therapy with T-DM1 intravenously on Day 1 and oral PD-0332991 on Days 5-18 Study Design and Methodology: This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with T-DM1 in patie...
What is the current status of trial NCT01976169?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2014-01-24. Estimated completion is 2021-05-19.
What interventions are being tested in trial NCT01976169?
The interventions under investigation include: PD-0332991 and T-DM1 (DRUG).
Who is sponsoring clinical trial NCT01976169?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01976169's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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