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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Antineoplastic Agents

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Paclitaxel

Albumin-Bound Paclitaxel

Xylometazoline

Tubulin Modulators

Antimitotic Agents

Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.

Elesclomol Sodium

Bradley J Monk

This phase II trial studies how well elesclomol sodium and paclitaxel work in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that has returned after a period of improvement (recurrent) or is persistent. Drugs used in chemotherapy, such as elesclomol sodium and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Elesclomol sodium may also help paclitaxel work better by making tumor cells more sensitive to the drug.

PRIMARY OBJECTIVES:

I. To estimate the antitumor activity of elesclomol (elesclomol sodium) and paclitaxel in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer primarily through the frequency of objective tumor responses.

II. To determine the nature and degree of toxicity of elesclomol and paclitaxel in this cohort of patients.

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival and overall survival of patients treated with elesclomol and paclitaxel.

OUTLINE:

Patients receive paclitaxel intravenously (IV) over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

A Phase II Evaluation of Elesclomol Sodium and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Proportion of Participants with Object Response (per response evaluation criteria in solid tumors criteria (RECIST V1.1) for target lesions as assessed by MRI: Complete Response (CR), disappearance of all target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

The frequency of patients who experienced at least one adverse effect (with a grade of 1 or higher). Adverse effects are defined as any unfavorable and unintended sign, symptom, or disease that occurs in a patient administered a medical treatment, whether the event is considered related or unrelated to the medical treatment.

The number of participants who experienced at least one grade three (or higher) adverse effect. The severity of observed adverse effects is graded using the NCI CTCAE version 4.0.

Progression-free survival (median, in months) will be analyzed by Kaplan-Meier analysis (progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (also a 5 mm absolute increase is also required), or a measurable increase in a non-target lesion, or the appearance of new lesions.

Overall survival (median, in months) will be analyzed by Kaplan-Meier analysis.

National Cancer Institute (NCI)

GOG Foundation

Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.

Elesclomol Sodium: Given IV

Paclitaxel: Given IV

Treatment (Paclitaxel, Elesclomol Sodium)

20-29 years

30-39 years

40-49 years

50-59 years

60-69 years

70-79 years

>= 80 years

Age, Customized

Sex: Female, Male

Adenocarcinoma, nos

Clear cell

Endometrioid

Serous

Cell Type

Christopher Purdy on behalf of James Kauderer

Proportion of Participants With Objective Response

Duration of Objective Response

Number of Participants Who Experienced at Least One Adverse Event

The Number of Participants Who Experienced at Least One Grade 3 Adverse Event

Progression-free Survival (Median)

Overall Survival (Median)

Overall Study

The aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose). This study will also characterize the pharmacokinetics of elesclomol and evaluate its anti-tumor activity in advanced solid tumors that are metastatic and unresectable.

A Safety Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium in Patients With Solid Tumors

A Phase 1 Multi-Dose Dose-Escalation Study of Elesclomol Sodium, Administered Once Weekly to Subjects With Solid Tumors

Synta Pharmaceuticals Corp.

David Hynds, Clinical Trials Manager

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer	NCT00888615	Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Ovarian Brenner... Ovarian Clear C... Ovarian Endomet... Ovarian Mucinou... Ovarian Seromuc... Ovarian Serous ... Ovarian Transit... Ovarian Undiffe... Primary Periton... Recurrent Fallo... Recurrent Ovari... Recurrent Prima...	Elesclomol Sodi... Paclitaxel	18 Years -	GOG Foundation
A Safety Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium in Patients With Solid Tumors	NCT00827203	Metastatic Soli...	Elesclomol Sodi...	18 Years -	Synta Pharmaceuticals Corp.
Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer	NCT00888615	Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Ovarian Brenner... Ovarian Clear C... Ovarian Endomet... Ovarian Mucinou... Ovarian Seromuc... Ovarian Serous ... Ovarian Transit... Ovarian Undiffe... Primary Periton... Recurrent Fallo... Recurrent Ovari... Recurrent Prima...	Elesclomol Sodi... Paclitaxel	18 Years -	GOG Foundation

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