Clinical Trial of PM00104 (Zalypsis®) in Patients With Advanced and/or Metastatic Endometrial or Cervical Cancer Previously Treated With One Line of Systemic Chemotherapy

NCT00900562 | Terminated Phase 2 Results

• 1 other identifier: PM104-B-001-09
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

Brief Summary

This study is a phase II clinical and pharmacokinetic trial of PM00104 (Zalypsis®) in patients with advanced and/or metastatic endometrial or cervical cancer previously treated with one line of systemic chemotherapy to evaluate the antitumor activity and to determine the safety profile, the pharmacokinetic profile and the pharmacogenomic profile.

Conditions

Uterine Cervical Cancer; Endometrial Cancer

Keywords

Zalypsis; Cancer; Endometrial; Uterine Cervical; PharmaMar

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Overall Response Rate defined as the percentage of patients with either complete response (CR) or partial response (PR) according to RECIST v.1.0. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation Criteria in Solid Tumors

  At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years

Secondary Outcomes (8)

• Best Tumor Response

  At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years

• Progression Free Survival

  From the date of first infusion of study treatment to the date of progression or death, up to 2 years

• Progression Free Survival Rate at 4 Months

  At 4 months

• Overall Survival

  From the date of first infusion to the date of death, up to 2 years

• PM00104 Plasma PK Parameters (Cmax) at First Infusion

  0 (Pre-infusion) and 1, 1.5, 3, 7, 24, 48, 168 hours after the end of first infusion (Day 1)

Study Arms (1)

Arm 1

EXPERIMENTAL

Zalypsis (PM00104)

Drug: Zalypsis ( PM00104)

Interventions

Zalypsis ( PM00104) DRUG

Zalypsis (PM00104) (2.5 mg/vial) is provided as a powder for concentrate for solution for infusion

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written informed consent, obtained from the patient before the beginning of any specific study procedures.
• Group 1 (endometrial cancer):
• Histologically confirmed advanced and/or metastatic endometrial cancer (any grade, including endometrioid, clear cell, serous and mixed types) with documented disease progression as per RECIST at study entry.
• Patients must have failed one prior systemic chemotherapy line for advanced/metastatic disease (excluding chemosensitizing chemotherapy); prior hormone therapy and biological therapy are allowed.
• Group 2 (cervical cancer):
• Histologically confirmed advanced and/or metastatic cervical cancer with documented disease progression as per RECIST at study entry.
• Patients must have failed one prior systemic chemotherapy line for advanced/metastatic disease (excluding chemosensitizing chemotherapy); prior hormone therapy and biological therapy are allowed.
• Complete recovery from the effects of prior radiotherapy and from any drug-related adverse events (AEs) derived from previous treatments, excluding alopecia and grade 1 peripheral neuropathy according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE, v.3.0).
• At least one measurable lesion ("target lesion" according to the RECIST), located in a non-irradiated area and adequately measured less than four weeks before study entry. Tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is clearly documented or biopsy proven.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1.
• Life expectancy ≥ 3 months.
• Appropriate bone marrow reserve, renal and hepatic functions:
• Platelet count ≥ 100 x 109/l, hemoglobin ≥ 9 g/dl and absolute neutrophil count (ANC) ≥ 1.5 x 109/l.
• Alkaline phosphatase (AP) ≤ 2.5 x upper limit of normality (ULN) (≤ 5 x ULN in case of extensive bone metastases).

You may not qualify if:

• Prior therapy with PM00104.
• Uterine sarcomas, adenosarcoma, and malignant Mullerian tumors.
• Cervical neuroendocrine or small cell carcinomas, nonepithelial cervical neoplasms such as sarcomas.
• Patients who have isolated recurrences (vaginal, pelvic or paraaortic) potentially curative with radiation therapy or surgery.
• Pregnant or lactating women, or in case of childbearing potential, women not using an appropriate contraceptive method.
• Less than three weeks from prior radiation therapy, biological therapy or chemotherapy, AND
• Less than six weeks from prior nitrosourea, mitomycin C, high-dose chemotherapy or radiotherapy involving the whole pelvis or over 50% of the spine, provided that acute effects of radiation treatment have resolved.
• Hormonal therapy and palliative radiation therapy (i.e., for control of pain from bone metastases) must be discontinued before study entry.
• Group 1 (endometrial cancer): more than one line of prior systemic chemotherapy for advanced/metastatic disease (excluding chemosensitizing chemotherapy), but not less than three weeks before.
• Group 2 (cervical cancer): more than one line of prior systemic chemotherapy for advanced/metastatic disease (excluding chemosensitizing chemotherapy, but not less than three weeks before.
• Patients with a prior invasive malignancy (except nonmelanoma skin cancer) who have had any evidence of disease within the last five years or whose prior malignancy treatment contraindicates the current protocol therapy.
• Patients with serious non-healing wound, ulcer, or bone fracture.
• This includes history of: abdominal fistula, gastrointestinal perforation or intra-abdominal abscess for which an interval of three to six months must pass before study entry.
• In addition, the patient must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
• Patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations.

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (4)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114-2617, United States

Location

UNM (University of New Mexico) Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

OU Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Neoplasms

Interventions

PM 00104

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.
• Organization: Pharma Mar S.A.

clinicaltrials@pharmamar.com

0034 91846 60 00

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 13, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 28, 2021
• Results First Posted: October 28, 2021

Record last verified: 2021-07

Locations

US (4)