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Trial record 53 of 602 for:    Recruiting, Not yet recruiting, Available Studies | Ovarian cancer

PTC-596 in Women With Ovarian Cancer Receiving Neoadjuvant Chemotherapy

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ClinicalTrials.gov Identifier: NCT03206645
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
PTC Therapeutics
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
This is an open-label Phase Ib dose-escalation study to determine the safety, tolerability, and pharmacokinetics of PTC-596 when combined with and following conventional chemotherapy and as maintenance therapy as a capsule (weight based dosing) and a tablet (fixed dosing) in women with epithelial ovarian, fallopian tube or primary peritoneal cancer which is previously untreated.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: PTC596 Phase 1

Detailed Description:
For all cohorts, the study drug PTC-596 will be orally administered prior to chemotherapy (paclitaxel and carboplatin), twice a week of each 21-day cycle. Chemotherapy will be administered on day 1 of each cycle by vein. Dose escalation levels for PTC-596 will occur per protocol and doses may be de-escalated for management of toxicity. Patients will receive a total of 3 cycles of PTC-596 and chemotherapy. Surgery will be performed within 6 weeks after the last dose of Cycle 3. An additional 3-7 cycles of PTC-596 and chemotherapy (carboplatin and paclitaxel) may be given as maintenance therapy for up to two years at the discretion of the treating physician.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This trial will utilize a traditional 3+ 3 design with dose escalation.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1B Trial With PTC-596 in High-Grade Serous Ovarian Cancer: a Targeted Approach Toward Chemoresistant Stem-Like Cancer Cells
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : February 1, 2024


Arm Intervention/treatment
Experimental: Carboplatin/Paclitaxel + PTC596
Carboplatin AUC 6mg/L IV on day 1; Paclitaxel 175mg/m2 IV on day 1; PTC596 PO, twice a week, on day 1, 4, 8, 11, 15 and 18 per 21-day cycle for the first 3 cycles.
Drug: PTC596
PTC596 will be given in combination with carboplatin and paclitaxel for up to 7 cycles depending on which cohort the patient is in.




Primary Outcome Measures :
  1. Maximum tolerated dose and dose limiting toxicities [ Time Frame: 42 days ]
    To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of PTC596 in combination with and following conventional chemotherapy and as maintenance as a capsule (weight-based dosing) and a tablet (fixed dosing). Standard chemotherapy will be comprised of carboplatin and weekly paclitaxel. The DLTs will be based on adverse events that occur during administration of the first 2 cycles of combination PTC596 and chemotherapy (a cycle = 21 days).

  2. Number of patients able to tolerate drug combination [ Time Frame: 3 years ]
    To examine the tolerability of the combination at the MTD of PTC596 assessed in combination with standard neoadjuvant chemotherapy.

  3. Phase 2 Dose [ Time Frame: 3 years ]
    To determine the recommended phase II dose (RP2D) of PTC596 in combination with standard neoadjuvant chemotherapy.


Secondary Outcome Measures :
  1. Evaluate clinical response [ Time Frame: 3 years ]
    Evaluate clinical response by measuring serum CA-125. If CA-125 is initially above the upper normal limit, it must normalize for patients to be considered in complete clinical response.

  2. Evaluate pharmacokinetic Area Under the Curve (AUC) [ Time Frame: 3 months ]
    To evaluate pharmacokinetic parameters of PTC596 in patients with stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer receiving neoadjuvant chemotherapy with carboplatin/paclitaxel

  3. Evaluate pharmacokinetic Maximum Concentration observed (Cmax) [ Time Frame: 3 months ]
    To evaluate pharmacokinetic parameters of PTC596 in patients with stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer receiving neoadjuvant chemotherapy with carboplatin/paclitaxel

  4. Evaluate pharmacokinetic Time of Maximum Concentration observed (Tmax) [ Time Frame: 3 months ]
    To evaluate pharmacokinetic parameters of PTC596 in patients with stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer receiving neoadjuvant chemotherapy with carboplatin/paclitaxel

  5. Evaluate pharmacokinetic half life (t1/2) [ Time Frame: 3 months ]
    To evaluate pharmacokinetic parameters of PTC596 in patients with stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer receiving neoadjuvant chemotherapy with carboplatin/paclitaxel

  6. Progression free survival [ Time Frame: one year ]
    The duration of time (one year) that patients are alive and their cancer is progression-free.

  7. Progression free survival [ Time Frame: two years ]
    The duration of time (two years) that patients are alive and their cancer is progression-free.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy.
  • Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
  • Adequate bone marrow function, renal function, hepatic function, and neurologic function per protocol.
  • Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
  • Patients must have a performance status score of 0, 1, or 2 by Eastern Cooperative Group (ECOG) criteria.
  • Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.
  • Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.
  • Patients must have pre-treatment tumor tissue available or agree for tissue collection from IR guided biopsy.
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Prior treatment with PTC596 or standard of care drugs (cis- or carboplatin or paclitaxel.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to PTC596 or other agents used in this study.
  • Have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.
  • Receiving treatment for active autoimmune disease.
  • History of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies within the last three years.
  • Prior radiotherapy to any portion of the abdominal cavity or pelvis.
  • Prior chemotherapy for any abdominal or pelvic tumor.
  • Known active hepatitis, ongoing systemic bacterial, fungal, or viral infection; known human immunodeficiency virus (HIV) infection or acquired-immunodeficiency syndrome (AIDS)-related illness.
  • Have concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study.
  • Have childbearing potential but not practicing adequate contraception.
  • History or active CNS disease.
  • Concomitant therapy with any of the following: other non-study cytotoxic chemotherapy; other investigational therapies.
  • Prior bone marrow/hematopoietic stem cell transplantation
  • History of solid organ, bone marrow, or progenitor cell transplantation
  • History of major surgical procedure within 28 days prior to start of study treatment
  • Presence or history of moderate to severe pulmonary dysfunction.
  • Use of an investigational drug within 4 weeks of dosing in the current study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206645


Contacts
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Contact: Ingrid Block, RN 405 271-8777 ingrid-block@ouhsc.edu

Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kathleen Moore, MD         
Sponsors and Collaborators
University of Oklahoma
PTC Therapeutics
Investigators
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Study Chair: Kathleen Moore, MD University of Oklahoma

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03206645     History of Changes
Other Study ID Numbers: PTC-001
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action