Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Doxorubicin

Liposomal doxorubicin

Tubulin Modulators

Antimitotic Agents

Dose of 50 mg/m2 by i.v. infusion over 1 hour every 28 days for up to 1 year

CAELYX

Dose of 175 mg/m2 by i.v. infusion over 3 hours starting on Day 1 of a 21-day cy

Paclitaxel HCl

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

The objective of this study is to compare the efficacy and safety of CAELYX versus Paclitaxel HCl in patients with epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy. The primary endpoint is time to progression (TTP) following treatment with either CAELYX or Paclitaxel HCl; the secondary endpoints are response rates, time to response, duration of response,quality of life assessment, and survival following treatment with either CAELYX or Paclitaxel HCl. Up to a total of 438 protocol-eligible patients with epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy will be enrolled in order to obtain 350 evaluable patients.

This is a randomized, open-label, comparative study of CAELYX versus Paclitaxel HCl in the treatment of patients with epithelial ovarian carcinoma following failure of first line chemotherapy with a platinum-based regimen. Patients entering the trial will be stratified prospectively for platinum-sensitivity and bulky disease and analyzed retrospectively for prior anthracycline therapy. Protocol-eligible patients, with measurable disease, who have received no more than one prior regimen, which was platinum-based, will be randomized to receive either a one-hour intravenous infusion of CAELYX, 50 mg/m2 every 28 days, or Paclitaxel HCl, 175 mg/m2 as a 3 hour infusion every 21 days. Patients will be treated for up to one year. It is suggested that responding patients receive at least 6 cycles of treatment. Patients with ongoing clinical benefit may continue study drug upon approval of the sponsor as long as it is in the patient's interest and in the absence of severe toxicity. It is suggested that patients exhibiting a complete response (CR) receive 2 subsequent cycles of treatment. Patients exhibiting partial response (PR) may continue to receive study drug as long as therapeutic benefit is being derived but it is suggested that they receive at least 3 subsequent cycles of study drug. Patients will undergo appropriate radiological imaging (x-ray, CT scan, MRI) to document baseline disease, as well as a chest x-ray and an assessment of left ventricular ejection fraction (LVEF) by MUGA scan within 30 days prior to the first dose of study drug. Patients will be followed weekly for hematological toxicities. Radiological imaging will be repeated every 7-8 weeks to assess disease status. Patients who achieve complete or partial response will be reevaluated 4 weeks later to confirm the initial observation of response. All patients will be followed for a minimum of one year for disease progression and survival. LVEF will be assessed by MUGA scan at baseline, when the cumulative anthracycline dose reaches 300 mg/m2 (500 mg/m2 epirubicin), and after every 2 cycles of CAELYX thereafter. Endomyocardial biopsy is recommended for patients who have received \> 400 mg/m2 of CAELYX alone or a cumulative anthracycline dose of \> 550 mg/m2 (including CAELYX; 900 mg/m2 if epirubicin). \[NOTE: This study was initiated on 7-May-1997. Due to poor accrual, the study enrollment was terminated on 31-Aug-1999. Patients were followed until study completion on 12-Apr-2000. During the preparation of the study report (beginning in May 2003), the sites were re-queried for clarification of safety and survival data.\]

DOXIL, dose of 50 mg/m2 by i.v. infusion over 1 hour every 28 days for up to 1 year. Paclitaxel, dose of 175 mg/m2 by i.v. infusion over 3 hours starting on Day 1 of a 21-day cycle for up to 1 year.

CAELYX Versus Paclitaxel HCl in Patients With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy

A Phase 3, Randomized, Open-Label, Comparative Study of CAELYX Versus Paclitaxel HCl in Patients With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy

Sequus Pharmaceuticals

ALZA

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

DIRECTOR MEDICAL LEADER

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Micronutrients

Antirheumatic Agents

Bone Density Conservation Agents

Anti-Infective Agents

Hematinics

Other Dietary Supplements

Amino Acids

Vitamins

Leucovorin

Fluorouracil

Vaccines

Cyclophosphamide

Avelumab

Calcium

Calcium, Dietary

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antimetabolites

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Antineoplastic Agents, Immunological

Brewer's Yeast

Glutamic Acid

Folate

Vitamin B9

NANT Neoadjuvant Triple Negative Breast Cancer Vaccine

A combination of agents will be administered to subjects in this study:

cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, avelumab, aldoxorubicin HCl, ALT-803, haNK, GI-4000, GI-6207, GI-6301, ETBX-011, ETBX-051 and ETBX-061

Standard treatment with a combination of doxorubicin, cyclophosphamide and paclitaxel.

L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt

5-Fluorouracil

albumin-binding prodrug of doxorubicin HCl

Aldoxorubicin HCl

Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin

nab-Paclitaxel

ETBX-011

ETBX-051

ETBX-061

Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins

GI-4000

GI-6207

GI-6301

Recombinant human super agonist interleukin-15 (IL-15) complex

ALT-803

haNK

2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

Doxorubicin HCL

paclitaxel

This is a randomized open-label phase 2 study to evaluate the efficacy and safety (as assessed by pCR) of the NANT Neoadjuvant TNBC Vaccine regimen (experimental arm) compared to the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm).

Treatment will be administered in 2 phases, a neoadjuvant phase and a postoperative phase. The neoadjuvant phase will be 18 weeks for patients enrolled in the experimental arm and 16 weeks for those enrolled in the control arm.

Following the neoadjuvant phase, all subjects will undergo determination of their current response status and appropriate breast surgery and node dissection after which assessment for pCR will be conducted following completion of neoadjuvant systemic therapy. Pathologists interpreting surgical specimens for pCR assessment will be blinded to the treatment arm.

All subjects, regardless of whether or not they have achieved a pCR, will then enter the postoperative phase where they will receive adjuvant treatment. A small portion of the corresponding neoadjuvant therapy, either nab-paclitaxel or paclitaxel, will be administered as adjuvant treatment postoperatively. Adjuvant treatment will continue in the postoperative phase until the subject experiences unacceptable toxicity (not correctable with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment.

Treatment will be administered in 2 phases, a neoadjuvant phase and a postoperative phase. For the experimental arm, subjects will receive treatment in the neoadjuvant phase for six 3-week cycles (ie, 18 weeks total). For the control arm, subjects will receive neoadjuvant treatment for a total of 16 weeks.

QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine

An Open-Label Randomized Phase 2 Trial Of The NANT NEOADJUVANT Triple-Negative Breast Cancer (TNBC) VACCINE VS Standard-Of-Care For The Neoadjuvant Treatment Of Subjects With TNBC

Compare the efficacy of the NANT neoadjuvant TNBC Vaccine treatment vs standard-of-care (SoC) therapy as assessed by pathologic complete response (pCR) rate in the breast and axilla.

Incidence of treatment -emergent adverse events

Time from randomization to first occurrence of advancement of disease

Time from date of first treatment to death from any cause

Presence of any disease recurrence, including location

Number of patients with a metastatic lesion

ImmunityBio, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CAELYX Versus Paclitaxel HCl in Patients With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy	NCT00653952	Ovarian Neoplas...	CAELYX Paclitaxel HCl	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine	NCT03554109	Triple Negative...	Leucovorin 5-Fluorouracil Aldoxorubicin H... nab-Paclitaxel ETBX-011 ETBX-051 ETBX-061 GI-4000 GI-6207 GI-6301 Avelumab ALT-803 haNK Cyclophosphamid... Doxorubicin HCL paclitaxel	18 Years -	ImmunityBio, Inc.

Spots Global Cancer Trial Database for doxorubicin hcl