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ThrombocytopeniaPhase 2NCT00771810

Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer

A Phase 2 study testing TXA127 in people with Thrombocytopenia and Neutropenia, run by Tarix Pharmaceuticals at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study will investigate the safety and effectiveness of two different dose levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine and carboplatin or gemcitabine and cisplatin prescribed to women for the treatment of ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Thrombocytopenia, Neutropenia, Lymphopenia
What is being tested?
TXA127
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
6 sitesUnited States
Study dates
Oct 2008to Dec 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

  • Females at least 18 years of age with ovarian carcinoma who are one of the following:
  • Newly diagnosed with ovarian cancer and chemotherapy naïve, or
  • Post a single previous course of chemotherapy, with a 3-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit, or
  • Post two or more previous courses of chemotherapy with a 6-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit.
  • Must be scheduled for a course of combination chemotherapy consisting of gemcitabine and cisplatin or gemcitabine and carboplatin to be administered in 21-day cycles
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Adequate bone marrow, renal, and hepatic functions as measured by standard chemistry and hematology blood tests
  • Adequate blood coagulation parameters as measured by standard blood tests for coagulation

Who cannot join

  • Any clinical or laboratory abnormality greater than Grade 2 toxicity (NCI criteria), with the exception of laboratory parameters specified in the inclusion criteria
  • Significant unstable cardiovascular disease
  • Uncontrolled high blood pressure
  • Current use of an angiotensin converting enzyme (ACE) inhibitor or angiotensin II antagonists
  • Evidence of metastatic disease to the bone
  • Metastatic disease to the CNS requiring treatment or radiation therapy
Show all 9Show fewer
  • Uncontrolled infection(s)
  • Radiation therapy or chemotherapy (except as specified in the inclusion criteria) within the previous 5 years
  • Concurrent use of hematopoietic or erythropoietic agents

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Schwartz Gynecologic Oncology, PLLC

    Brightwaters, New York, 11718

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • USC - LAC Medical Center

    Los Angeles, California, 90033

  • University of Southern Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • University of California - Irvine, Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Associates in Women's Health

    Wichita, Kansas, 67208

Other trials in United States

About this study

Official title: Ph IIb Study Evaluating the Safety & Efficacy of TXA127 in the Reduction of Incidence and Severity of Thrombocytopenia in Patients Receiving Combination Gemcitabine and Platinum Therapy for Ovarian, Fallopian Tube, or Peritoneal Carcinoma

This research study will investigate the safety and effectiveness of two different dose levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine and carboplatin or gemcitabine and cisplatin prescribed to women for the treatment of ovarian cancer. This experimental drug is called TXA127 and is being tested for effectiveness to see if it will help reduce some of the side effects of the chemotherapy, primarily low blood platelet levels that lead to excess bleeding. This study also intends to test the safety of TXA127 when given as an injection under the skin on a daily basis concurrently with up to 6 cycles of the prescribed chemotherapy.

Read the detailed description

This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study comparing safety and efficacy of two dose levels of TXA127 when administered during 6 cycles of combination gemcitabine and platinum-based chemotherapy. This study intends to investigate the effectiveness of TXA127 for the mitigation of severity and/or incidence of thrombocytopenia, as well as safety when administered as a self-injected, subcutaneous solution.

Females 18 years of age or older with a confirmed diagnosis of ovarian carcinoma who are scheduled to undergo combination chemotherapy with gemcitabine and carboplatin or gemcitabine and cisplatin will be considered for this study. Subjects may be chemotherapy naïve, newly diagnosed, or post a single course of chemotherapy followed by a progression- and treatment-free interval of at least 3 months, or post 2 or more previous courses of chemotherapy after a progression- and treatment-free interval of at least 6 months.

Subjects will be randomized in a 1:1:1 ratio to one of the following three blinded treatment groups: placebo, 100 ug/kg/day TXA127 and 300 ug/kg/day TXA127.

Treatment will be concurrent with up to six consecutive 21-day cycles of one of the following gemcitabine and platin regimens:

Regimen A

  • Intravenous cisplatin therapy at a dose of 30-50 mg/m2 given on Day 1 of the cycle
  • Intravenous gemcitabine at a dose of 800 mg/m2 given on Day 1 after cisplatin and on Day 8 of the cycle.

Regimen B

  • Intravenous gemcitabine at a dose of 1000 mg/m2 given on Days 1 and 8 of the cycle
  • Intravenous carboplatin AUC 4 given after gemcitabine on Day 1 of the cycle

TXA127 will be self-administered as a subcutaneous injection by the subject once daily on Days 2-6 and 9-15 during each cycle of chemotherapy. Blood specimens will be drawn for hematologic analysis on Days 1, 8 and 15 of each treatment cycle.

Being tested
TXA127, Placebo
Keywords
Ovarian Cancer, Thrombocytopenia, Cytopenia, Chemotherapy
Medical subject headings
Thrombocytopenia, Neutropenia, Lymphopenia, Anemia, Ovarian Neoplasms, Cytopenia

What participants receive

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

  • TXA127Drug

    Also called Angiotensin 1-7

    Once daily subcutaneous injection of 100 ug/kg

  • TXA127Drug

    Also called Angiotensin 1-7

    Once daily subcutaneous injection of 300 ug/kg

  • PlaceboDrug

    Once daily subcutaneous injection of placebo

Study groups in NCT00771810
Study groupRoleWhat they receive
PlaceboPlacebo comparatorCombination gemcitabine and platinum-based chemotherapy with concurrent placebo
Receives: Drug: Placebo
TXA127 100 ug/kgExperimentalCombination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
Receives: Drug: TXA127
TXA127 300 ug/kgExperimentalCombination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Receives: Drug: TXA127

What is being measured

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

  1. Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3

    Mean percentage of cycles with platelet counts below 50,000/mm3

    Measured: During a maximum of six 3-week chemotherapy cycles

Secondary outcomes (9)

  1. Subjects With Platelet Counts Below 50,000/mm3

    Number of subjects who experienced a platelet count below 50,000/mm3

    Measured: During a maximum of six 3-week chemotherapy cycles

  2. Treatment Cycles With Platelets Counts Below 25,000/mm3

    Mean percentage of treatment cycles where platelets counts were below 25,000/mm3

    Measured: During a maximum of six 3-week chemotherapy cycles

  3. Chemotherapy Dose Intensity and Dose Density

    Mean percentage of cycles where projected (target) chemotherapy dose was maintained

    Measured: During a maximum of six 3-week chemotherapy cycles

  4. Lymphopenia as Determined by Lymphocyte Count

    Number of subjects with a treatment emergent adverse event of lymphopenia

    Measured: During a maximum of six 3-week chemotherapy cycles

  5. Neutropenia

    Number of subjects with a treatment emergent adverse event of neutropenia

    Measured: During a maximum of six 3-week chemotherapy cycles

  6. Anemia

    Number of subjects with a treatment emergent adverse event of anemia

    Measured: During a maximum of six 3-week chemotherapy cycles

  7. Mucositis

    Number of subjects with a treatment emergent adverse event of mucositis

    Measured: During a maximum of six 3-week chemotherapy cycles

  8. Alopecia

    Number of subjects with a treatment emergent adverse event of alopecia

    Measured: During a maximum of six 3-week chemotherapy cycles

  9. Rescue Treatment for Hematopoiesis and Mucositis

    Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:

    1. Transfusions
    2. Filgrastim or Pegfilgrastim
    3. Erythropoietin
    4. Palifermin

    Measured: During a maximum of six 3-week chemotherapy cycles

Timeline

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

  1. First posted13 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionDec 2011
  4. Study completionDec 2011

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00771810
Sponsor's protocol ID
TXA127-2007-002
Status last verified
Oct 2017
First submitted
9 Oct 2008
Last updated
13 Nov 2017
Data monitoring committee
No

Publications

  • Rodgers KE, Oliver J, diZerega GS. Phase I/II dose escalation study of angiotensin 1-7 [A(1-7)] administered before and after chemotherapy in patients with newly diagnosed breast cancer. Cancer Chemother Pharmacol. 2006 May;57(5):559-68. doi: 10.1007/s00280-005-0078-4. Epub 2005 Aug 12.

    PubMed 16096787

  • Ellefson DD, diZerega GS, Espinoza T, Roda N, Maldonado S, Rodgers KE. Synergistic effects of co-administration of angiotensin 1-7 and Neupogen on hematopoietic recovery in mice. Cancer Chemother Pharmacol. 2004 Jan;53(1):15-24. doi: 10.1007/s00280-003-0710-0. Epub 2003 Oct 16.

    PubMed 14569417

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TXA127 in people with Thrombocytopenia and Neutropenia, run by Tarix Pharmaceuticals at 6 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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. Some participants in this study may receive a placebo. 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 7 Jun 2013). 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?

Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3 (time frame: During a maximum of six 3-week chemotherapy cycles). 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 NCT00771810, which also lists 2 linked publications.

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 13 Nov 2017.

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