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NCT02448537 · ClinicalTrials.gov registry record · Phase 2
A Phase II Multi-Strata Study of PM01183 as a Single Agent or in Combination With Conventional Chemotherapy in Metastatic and/or Unresectable Sarcomas
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT02448537: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT02448537 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02448537, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
This research study is investigating a drug called PM01183 alone and in combination with chemotherapy drugs called gemcitabine or doxorubicin as a possible treatment for metastatic or unresectable Sarcoma.
Primary Outcome
The number of participants that achieved either Stable Disease (SD) or a Partial Response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) at 24 weeks. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on stud
Interventions
- DRUG Doxorubicin
- DRUG Gemcitabine
- DRUG PM01183
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2015-08 |
| Est. Completion | 2019-04-01 |
| Phase | Phase 2 |
What the finished NCT02448537 record still lists
NCT02448537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Doxorubicin is the first listed.
NCT02448537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02448537 about?
NCT02448537 is a clinical study titled "A Phase II Multi-Strata Study of PM01183 as a Single Agent or in Combination With Conventional Chemotherapy in Metastatic and/or Unresectable Sarcomas". This research study is investigating a drug called PM01183 alone and in combination with chemotherapy drugs called gemcitabine or doxorubicin as a possible treatment for metastatic or unresectable Sarcoma.
What is the current status of trial NCT02448537?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2015-08. Estimated completion is 2019-04-01.
What interventions are being tested in trial NCT02448537?
The interventions under investigation include: Doxorubicin (DRUG), Gemcitabine (DRUG), PM01183 (DRUG).
Who is sponsoring clinical trial NCT02448537?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02448537's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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