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Uterine Cervical CancerPhase 2NCT00900562

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

A Phase 2 study testing Zalypsis ( PM00104) in people with Uterine Cervical Cancer and Endometrial Cancer, run by PharmaMar at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uterine Cervical Cancer, Endometrial Cancer
What is being tested?
Zalypsis ( PM00104)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
4 sitesUnited States
Study dates
Aug 2009to Sep 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN in case of hepatic metastases).
  • Total bilirubin ≤ 1.5 x ULN, unless due to Gilbert's syndrome.
  • Renal function: patients with calculated creatinine clearance (using Cockcroft and Gault formula) ≥ 30 ml/min.
  • Albumin ≥ 2.5 g/dl.
  • Left ventricular ejection fraction (LVEF) within normal limits (LVEF of at least 50%).
  • Women of childbearing potential must have a negative serum pregnancy test before study entry. In case of childbearing potential, the patients and their partners must agree to use a medically acceptable method of contraception.

Who cannot join

  • 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
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  • 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.
  • Evidence of progressive or symptomatic central nervous system (CNS) metastases or leptomeningeal metastases.
  • Other diseases or serious conditions:
  • Increased cardiac risk as defined by:
  • Unstable angina or myocardial infarction within 12 months before inclusion in the study.
  • New York Heart Association (NYHA) grade II or greater congestive heart failure.
  • Symptomatic arrhythmia or any arrhythmia requiring ongoing treatment.
  • Abnormal electrocardiogram (ECG), i.e., patients with the following are excluded: QT prolongation - QTc > 480 msec; signs of cardiac enlargement or hypertrophy; bundle branch block; partial blocks;signs of ischemia or necrosis, and Wolff Parkinson White patterns.
  • History or presence of valvular heart disease.
  • Uncontrolled arterial hypertension despite optimal medical therapy.
  • Previous mediastinal radiotherapy.
  • Previous treatment with doxorubicin at cumulative doses exceeding 400 mg/m2.
  • History of significant neurological or psychiatric disorders.
  • Active infection requiring systemic treatment.
  • Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis).
  • Immunocompromised patients, including those known to be infected with the human immunodeficiency virus (HIV).
  • Uncontrolled (i.e., requiring relevant changes in medication within the last month or hospital admission within the last three months) endocrine diseases (e.g., diabetes mellitus, hypo- or hyperthyroidism, adrenal disorder).
  • Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in the study. The investigator should feel free to consult the Study Coordinator or the Sponsor for uncertainty in this regard.
  • Limitation of the patient's ability to comply with the treatment or to follow-up at a participating center. Patients enrolled into this trial must be treated and followed at a participating center.
  • Treatment with any investigational product within 30 days prior to inclusion in the study.
  • Known hypersensitivity to any component of PM00104.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • UNM (University of New Mexico) Cancer Center

    Albuquerque, New Mexico, 87131

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114-2617

  • OU Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

Other trials in United States

About this study

Official title: 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

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.

Being tested
Zalypsis ( PM00104)
Keywords
Zalypsis, Cancer, Endometrial, Uterine Cervical, PharmaMar
Medical subject headings
Uterine Cervical Neoplasms, Endometrial Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zalypsis ( PM00104)Drug

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

Study groups in NCT00900562
Study groupRoleWhat they receive
Arm 1ExperimentalZalypsis (PM00104)
Receives: Drug: Zalypsis ( PM00104)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (8)

  1. Best Tumor Response

    Best tumor response was defined as the best response achieved during the study according to RECIST v1.0 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

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

  2. Progression Free Survival

    Progression-free survival (PFS) was defined as the time from the date of first infusion of study treatment to the date of progression or death (due to any cause). If progression or death had not occurred at the time of the analysis, PFS was censored on the date of last tumor evaluation.

    PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density

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

  3. Progression Free Survival Rate at 4 Months

    Progression-free survival rate at 4 months was defined as the percentage of patients who did not progress and were alive at 4 months.

    PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density

    Measured: At 4 months

  4. Overall Survival

    Overall survival (OS) was defined as the time from the date of first infusion of study treatment to the date of death (due to any cause). Patients with no documented death were censored at the last date they were known to be alive

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

  5. PM00104 Plasma PK Parameters (Cmax) at First Infusion

    Cmax Maximum plasma concentration, directly determined from the experimental data

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

  6. PM00104 Plasma PK Parameters (AUC) at First Infusion

    AUC Area under the plasma concentration-time curve from time zero to infinity.

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

  7. PM00104 Plasma PK Parameters (Cmax) at Second Infusion

    Cmax Maximum plasma concentration, directly determined from the experimental data

    Measured: 0 (Pre-infusion) and 1, 1.5, 3, 7, 24, 48, 168 hours after the end of second infusion (Day 8)

  8. PM00104 Plasma PK Parameters (AUC) at Second Infusion

    AUC Area under the plasma concentration-time curve from time zero to infinity

    Measured: 0 (Pre-infusion) and 1, 1.5, 3, 7, 24, 48, 168 hours after the end of second infusion (Day 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionSep 2011
  4. Study completionSep 2011

Why it stopped: Slow and poor recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00900562
Sponsor's protocol ID
PM104-B-001-09
Status last verified
Jul 2021
First submitted
12 May 2009
Last updated
28 Oct 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zalypsis ( PM00104) in people with Uterine Cervical Cancer and Endometrial Cancer, run by PharmaMar at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00900562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.

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