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Ovarian CancerPhase 1/2NCT00889382

A Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)

A Phase 1/2 study testing OSI-906 and Paclitaxel in people with Ovarian Cancer and Solid Tumors, run by Astellas Pharma Inc at 46 sites in 10 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a multi-center, randomized, open-label, phase 1/2 study of continuous weekly paclitaxel and escalating doses of intermittent or continuous OSI-906 in patients with recurrent/relapsed ovarian and other solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ovarian Cancer, Solid Tumors
What is being tested?
OSI-906 and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
46 sitesin 10 countries
Study dates
5 Aug 2009to 25 Aug 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed epithelial ovarian carcinoma Patients with fallopian or peritoneal cancer will also be eligible
  • Patients with any solid tumor that may be treated with weekly paclitaxel will be eligible for the phase 1 portion
  • For the phase 2 portion, patients must have elevated CA125 levels evaluable/assessable according to Gynecological Cancer Intergroup (GCIG) criteria (ie, > 70 U/mL) documented by 2 measurements at least 1 week apart
  • Patients must have radiologically confirmed progressive disease by RECIST v1.1 criteria within 6 months prior to randomization. (patients must have measurable disease according to RECIST v1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 -1
  • Predicted life expectancy ≥ 12 weeks
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  • Patients may have had prior therapy, providing the following conditions are met:
  • Chemotherapy: Prior chemotherapy must have been completed at least 3 weeks prior to study enrollment (6 weeks for mitomycin C, nitrosoureas or high-dose carboplatin [≥ 600 mg/m²]and 4 weeks for investigational drugs
  • Patient should have recovered from any drug-related toxicities (with the exception of grade 1 neuropathy and or alopecia)
  • Phase 1: While there is no limit on the number of prior regimens for patients entered into the phase 1 portion, any prior taxane therapy must have been administered on a 3 week schedule
  • Phase 2: Patients must have received prior chemotherapy, which must have contained a platinum and a taxanes at some point. Any prior taxanes therapy must have been administered on a 3 week schedule. A maximum of 2 prior chemotherapy regimens are permitted. Patients must be refractory radiologically confirmed by computerized tomography (CT) scan progressive disease (PD) during chemotherapy) or resistant (radiologically confirmed by CT scan PD within six months of completing chemotherapy) to their last platinum-containing chemotherapy regimen
  • Radiation: Patients may have had prior radiation therapy provided they have recovered from the acute, toxic effects of radiotherapy prior to registration/randomization. Radiated lesions cannot be chosen as the target lesions
  • A minimum of 21 days must have elapsed between the end of radiotherapy and registration/randomization into the study unless the radiation affected less than 25% of bone marrow
  • Surgery: Previous surgery is permitted provided that adequate wound healing has occurred prior to registration/randomization
  • Fasting glucose ≤ 150 mg/dL (8.3 mmol/L)
  • Adequate hematopoietic, hepatic, and renal function defined as follows:
  • Neutrophil count ≥ 1.5 x 10 ^9 /L and platelet count > = 100 x 10^9/L;
  • Bilirubin ≤ 1.5 x Upper Limit of Normal (ULN);
  • AST and/or ALT ≤ 2.5 x ULN or < = 5 x ULN if patient has documented liver metastases; and
  • Serum creatinine ≤ 1.5 x ULN
  • Female patient must be either:
  • Of non childbearing potential:
  • post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
  • documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening)
  • Or, if of childbearing potential:
  • must have a negative urine pregnancy test at Screening, and
  • must use two forms of birth control (one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days [or 5 half lives, whichever is longer] after final study drug administration
  • Female patient must not be breastfeeding at Screening or during the study period and for 28 days [or 5 half lives of the study drug whichever is longer] after final study drug administration
  • Female patient must not donate ova starting at Screening and throughout the study period and for 28 days [or 5 half lives of the study drug whichever is longer] after final study drug administration
  • Patients must provide verbal and written informed consent to participate in the study

Who cannot join

  • Diabetes mellitus currently requiring medication (eg, insulin or oral hypoglycemics)
  • During the phase 2 portion, patients with histology of abdominal adenocarcinoma of unknown origin or a diagnosis of a borderline ovarian tumor
  • Previous or concurrent malignancies (excluding curatively treated basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) unless the patient has been in remission for at least 3 years
  • History of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac diseases includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea)
  • History of cerebrovascular accident (CVA) within 6 months prior to registration/randomization or that is not stable
  • Prior therapy with an insulin-like growth factor (IGF-1R) inhibitor
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  • Use of drugs that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing
  • Known or prior hypersensitivity to taxanes in spite of premedication or drugs containing Cremophor
  • Gastro-intestinal abnormalities, including bowel obstruction, inability to take oral medication, requirement for intravenous (IV) alimentation,active peptic ulcer or prior surgical procedures or bowel resection affecting absorption
  • Active infection or serious underlying medical condition (including any type of active seizure disorder within 12 months prior to registration/randomization) that would impair the ability of the patient to receive protocol treatment
  • History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
  • Pregnancy or breast-feeding
  • Symptomatic brain metastases that are not stable, require steroids, are potentially life threatening, or that have required radiation within 28 days prior to registration/randomization
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug
  • History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (≥ grade 3), left bundle branch block (LBBB), or asymptomatic sustained ventricular tachycardia are not allowed. Patients with atrial fibrillation controlled by medication are not excluded. Patients with mean QTcF interval ≥ 450 msec at screening are excluded
  • Use of drugs that have a known risk of causing Torsade de Pointes (TdP) or that that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing are prohibited
  • Use of the potent CYP1A2 inhibitors ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded
  • Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of Screening or during the course of the study

Trial locations and contacts

46 sites in 10 countries.

46 sites in 10 countries

Australia9 sites

  • St. John of God Hospital, Bunbury

    Bunbury, Western Australia, 6230

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Launceston General Hospital

    Launceston, Tasmania, 7250

  • Royal Adelaide Hospital

    North Terrace, South Australia, 5000

  • Sir Charles Gairdner Hospital

    Perth, Western Australia, 6009

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • St. John of Gog Hospital, Subiaco

    Subiaco, Western Australia, 6008

  • WestMead Hospital

    Westmead, New South Wales, 2145

  • Border Medical Oncology

    Wodonga, Victoria, 3690

Other trials in Australia

United States8 sites

  • Blumenthal Cancer Center - Main

    Charlotte, North Carolina, 28204

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Horizon Oncology Center

    Lafayette, Indiana, 47906

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07960

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Department of Obstetrics and Gynecology, University of California, Irvine

    Orange, California, 92868

  • Mayo Clinic

    Scottsdale, Arizona, 85259

Other trials in United States

United Kingdom7 sites

  • Royal Marsden Hospital

    London, SW3 6JJ

  • University College Hospital

    London, WC1E 6BT

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Mount Vernon Cancer Center

    Northwood, HA62RN

  • Churchill Hospital

    Oxford, OX37LI

  • Drug Development Unit Royal Mardsen NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

  • Christie NHS Foundation Trust

    Withington, M20 4BX

Other trials in United Kingdom

Italy4 sites

  • Universitaria di Bologna Policlinico

    Bologna, 40138

  • Ospedale di Carpi, AUSL di Modena

    Carpi, 91012

  • Instituto Europeo di Oncologia

    Milan, 20141

  • Oncology IDI- IRCSS

    Roma, 67100

Other trials in Italy

Romania4 sites

  • Institutul Oncologic Prof. Dr. Ion. Chiricuta Sectia de Oncologie Medicala

    Cluj-Napoca, 400015

  • Institutul Oncologic Prof. Dr. Ion. Chiricuta Sectia Radiologie

    Cluj-Napoca, 400015

  • Oncology Medical Centre SCM

    Iași, 700106

  • Clinical Caunty Hospital Mures

    Mures, 540072

Other trials in Romania

Russia4 sites

  • Central Clinical Hospital

    Moscow, 129128

  • Moscow City Oncology Hospital

    Moscow, 143423

  • State Institution Medical Radiology Scientific Center

    Obninsk, 249036

  • Sity Clinical Oncology

    Saint Petersburg, 198255

Other trials in Russia

Canada3 sites

  • Juravinski Cancer Center

    Hamilton, Ontario, L8V 5C2

  • McGill University

    Montreal, Quebec, H3T 1E2

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Czechia3 sites

  • University Hospital Hradec Kralove

    Kralove, 50005

  • University Hospital Ostrava

    Ostrava- Poruba, 70852

  • General University Hospital, Department of Obstetrics and Gynecology

    Prague, 212000

Other trials in Czechia

Poland3 sites

  • III Oddzial Onkologii Ginekologicznej

    Lublin, 20-090

  • Oddzial Radioterapii

    Poznan, 61 866

  • Klinika Onkologii AM w Poznaniu

    Poznan, 61-878

Other trials in Poland

Switzerland1 site

  • Ospedale San Giovanni

    Bellinzona, CH-6500

Other trials in Switzerland

About this study

Official title: A Phase 1/2 Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)

This is a multi-center, randomized, open-label, phase 1/2 study of continuous weekly paclitaxel and escalating doses of intermittent or continuous OSI-906 in patients with recurrent/relapsed ovarian and other solid tumors.

Read the detailed description

The phase 1 dose escalation portion will establish the maximum tolerated dose (MTD) in patients with advanced solid tumors. Once the recommended phase 2 dose (RP2D) is established for both schedules, the phase 2 study will begin. Patients with relapsed/recurrent epithelial ovarian cancer will be randomized 1:1:1 to 3 treatment groups.

Being tested
OSI-906, Paclitaxel
Keywords
Ovarian, IGF-1R, Paclitaxel, Ovarian Cancer, OSI-906, Solid Tumors
Medical subject headings
Ovarian Neoplasms, Insulin-Like Growth Factor I, Resistance To

What participants receive

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

  • OSI-906Drug

    Administered orally

  • PaclitaxelDrug

    Administered intravenously

Study groups in NCT00889382
Study groupRoleWhat they receive
Phase 1 Arm AExperimentalIntermittent OSI-906 Once Daily (QD) on Days 1 - 3, 8 - 10, and 15 - 17 with paclitaxel on Days 1, 8, and 15 (except Treatment Period 1 (TP 1); in TP 1 OSI-906 on Days 1 - 3, 8 - 10, 15 - 17, and 22 - 24 with paclitaxel on Days 8, 15, and 22)
Receives: Drug: OSI-906; Drug: Paclitaxel
Phase 1 Arm B1ExperimentalContinuous OSI-906 Twice Daily (BID) (Days 1 - 21) with paclitaxel dosing on Days 1, 8, and 15;(except TP 1; in TP 1 OSI-906 on Days 1 - 3, 8 - 10, 15 - 17, and 22 - 24 with paclitaxel on Days 8, 15 and 22)
Receives: Drug: OSI-906; Drug: Paclitaxel
Phase 1 Arm B2ExperimentalContinuous OSI-906 BID (Days 1 - 21) with paclitaxel dosing on Days 1, 8, and 15 (except TP 1; in TP 1 OSI-906 on Days 1 - 3, 8 - 10, 5 - 17, and 22 - 24 with paclitaxel on Days 8, 15, and 22); (additional PK sampling on Days 9 or 13 0r 14 for TP 1)
Receives: Drug: OSI-906; Drug: Paclitaxel
Phase 1 Arm B3ExperimentalContinuous OSI-906 BID (Days 1 - 21) with paclitaxel dosing on Days 1, 8, and 15 with no separation in OSI-906 and paclitaxel dosing (except TP 1; in TP 1 continuous OSI-906 dosing 2 hours prior to the initiation of paclitaxel infusion on Day 8 only, with paclitaxel on Days 8, 15, and 22, and additional PK sampling on Day 9 or 13 or 14)
Receives: Drug: OSI-906; Drug: Paclitaxel
Phase 2 Arm AExperimentalIntermittent OSI-906 QD on Days 1 - 3, 8 - 10, and 15 - 17 with paclitaxel on Days 1, 8, and 15
Receives: Drug: OSI-906; Drug: Paclitaxel
Phase 2 Arm BExperimentalContinuous OSI-906 BID from Day 1 onwards with paclitaxel on Days 1, 8, and 15
Receives: Drug: OSI-906; Drug: Paclitaxel
Phase 2 Arm CExperimentalPaclitaxel on Days 1, 8, and 15
Receives: Drug: Paclitaxel
Phase 2 Arm C Roll-overExperimentalContinuous OSI-906 BID from Day 1 onwards
Receives: Drug: OSI-906

What is being measured

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

  1. Determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

    Primary outcome measure for Phase 1 portion

    Measured: 28 days

  2. Progression Free Survival (PFS)

    Primary outcome measure for the Phase 2 portion; The time from the date of randomization until date of radiographic disease progression per RECIST v1.1 or until death due to any cause

    Measured: 36 months

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    The proportion of patients with a confirmed response of Complete Response (CR) or Partial Response (PR) per RECEIST v1.1

    Measured: 36 months

  2. Cancer Antigen 125 (CA125) Response Rate

    Response Rate is defined as at least 50% reduction in serum CA-125 levels from pretreatment levels; Response rate is the proportion of patients with a CA-125 response among evaluable patients

    Measured: 36 months

  3. Duration of Response (DOR)

    The time from the date of the first documented radiographic response (CR/PR) to first documented radiographic progression or death due to underlying cancer

    Measured: 36 months

  4. Duration of CA-125 Response (CA-125 DOR)

    The time from the date of the first documented CA-125 response to the date of CA-125 progression

    Measured: 36 months

  5. Overall Survival (OS)

    The time from the date of randomization until the documented date of death

    Measured: 36 months

  6. Safety assessed via physician exam, vital signs, clinical laboratory tests, electrocardiograms (ECG), and adverse events

    Measured: 36 months

Timeline

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

  1. First posted28 Apr 2009 (estimated)
  2. Study start5 Aug 2009
  3. Primary completion1 Aug 2014
  4. Study completion25 Aug 2014

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00889382
Sponsor's protocol ID
OSI-906-202
Other IDs
2009-010319-34, 2009
Status last verified
Nov 2024
First submitted
6 Apr 2009
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OSI-906 and Paclitaxel in people with Ovarian Cancer and Solid Tumors, run by Astellas Pharma Inc at 46 sites in 10 countries.

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 30 inclusion and 18 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Australia, United States, United Kingdom, Italy, Romania and 5 more countries. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) (time frame: 28 days). The study lists 2 primary outcomes in all. 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 NCT00889382.

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 20 Nov 2024.

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