Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Gemcitabine

Doxorubicin

Liposomal doxorubicin

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.

* PM01183 predetermined dose daily via IV per cycle
* Doxorubicin predetermined dose daily via IV per cycle

Prior anthracycline exposure and without prior gemcitabine exposure

* PM01183 predetermined dose given twice via IV per cycle
* Gemcitabine predetermined dose given twice via IV per cycle

Patients who have received at least both prior anthracycline and prior gemcitabine

-PM01183 predetermined dose once via IV per cycle

PM01183

Gregory Cote, MD PhD

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.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

PM01183 is a new drug that is believed to bind DNA cause double strands of DNA to break. This drug has been studied in previous research studies, and these suggest that it may slow or stop the growth of cancers. The FDA (the U.S. Food and Drug Administration) has not approved PM01183 as a treatment for any disease.

In this research study, the investigators are trying to assess the effects, good or bad, that PM01183, administered either alone or in combination with gemcitabine or doxorubicin has on metastatic or unresectable sarcoma.

A Phase II Multi-Strata Study of PM01183 as a Single Agent or in Combination With Conventional Chemotherapy in Metastatic and/or Unresectable Sarcomas

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 study.

The overall response rate is the number of participants that achieved either Stable Disease (SD), a Partial Response (PR), or a Complete Response (CR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). The overall response rate is the best response recorded from the start of treatment until disease progression/recurrence.

* Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
* 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 study.

Summary of the serious adverse events (SAE) experienced by participants that were deemed to be at least possibly related to PM01183 when administered alone or with Doxorubicin or Gemcitabine. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE v4).

Dana-Farber Cancer Institute

PharmaMar

Massachusetts General Hospital

MD PhD

Anthracycline-naïve patients will receive combination of PM01183 and Doxorubicin per cycle.

* PM01183 predetermined dose daily via IV per cycle
* Doxorubicin predetermined dose daily via IV per cycle

PM01183

Doxorubicin

Stratum A

Prior anthracycline exposure and without prior gemcitabine exposure

* PM01183 predetermined dose given twice via IV per cycle
* Gemcitabine predetermined dose given twice via IV per cycle

PM01183

Gemcitabine

Stratum B

Patients who have received at least both prior anthracycline and prior gemcitabine

-PM01183 predetermined dose once via IV per cycle

PM01183

Stratum C

PM01183 and Doxorubicin

PM01183 and Gemcitabine

Single Agent PM01183

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black or African-American

Asian

More Than One Race

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

Gregory Cote, M.D., Ph.D

Two participants (one from the PM01183 and Doxorubicin arm and one from the PM01183 alone arm) were not able to be evaluated for response.

Spots Global Cancer Trial Database for A Phase II Multi-Strata Study of PM01183 as a Single Agent or in Combination With Conventional Chemotherapy in Metastatic and/or Unresectable Sarcomas

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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