Ovarian CancerPhase 2NCT02317705

Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer

A Phase 2 study testing OTL38, Near infrared camera imaging system and Laparotomy in people with Ovarian Cancer, run by On Target Laboratories, LLC at 4 sites in United States.

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 study is being done to: test the safety of OTL38 see if OTL38 helps light up the cancer when viewed with the special camera system test the safety of the special camera system for use along with OTL38 during surgery Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Ovarian Cancer
What is being tested?: OTL38, Near infrared camera imaging system and Laparotomy
Type of treatment: Injection or infusion, Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 4 sitesUnited States
Study dates: Dec 2014to Nov 2015
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

Female patients 18 years of age and older
Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary debulking or interval debulking surgery, and:
Who are scheduled to undergo laparotomy for the debulking surgery OR
Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery, if cancer is detected on the laparoscopy
A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential
Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments

Who cannot join

Previous exposure to OTL38
Known FR alpha-negative ovarian cancer
Planned surgical approach via laparoscopy or robotic surgery
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
History of anaphylactic reactions or severe allergies
History of allergy to any of the components of OTL38, including folic acid

Show all 14Show fewer

Pregnancy, or positive pregnancy test
Clinically significant abnormalities on electrocardiogram (ECG)
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Impaired renal function defined as eGFR< 50 mL/min/1.73m2
Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin.
Known Stage IV ovarian cancer with Brain Metastases
Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery
Known sensitivity to fluorescent light

Trial locations and contacts

4 sites in 1 country.

United States4 sites

University of CA at Irvine Chao Cancer Center
Orange, California, 92868
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic-Rochester
Rochester, Minnesota, 55905
Moffitt Cancer Center
Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 2, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer

This study is being done to:

test the safety of OTL38
see if OTL38 helps light up the cancer when viewed with the special camera system
test the safety of the special camera system for use along with OTL38 during surgery

Conditions: Ovarian Cancer
Being tested: OTL38, Near infrared camera imaging system, Laparotomy
Medical subject headings: Ovarian Neoplasms

What participants receive

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

OTL38Drug
Also called OTL38 for Injection, CYTALUX™ (pafolacianine) injection
Near infrared camera imaging systemDevice
Near infrared camera imaging system
LaparotomyProcedure or surgery
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

Study groups in NCT02317705
Study group	Role	What they receive
Patients Receiving OTL38	Experimental	All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging. Receives: Drug: OTL38; Device: Near infrared camera imaging system; Procedure: Laparotomy

What is being measured

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

Sensitivity of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.
Sensitivity for the detection of folate receptor-alpha positive (FRAP) ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAO ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by the pathology/ and immunohistochemistry lab (TP+FN). 95% lower one-sided confidence interval was used.
Measured: Day of Surgery (Day 1)
Positive Predictive Value (PPV) of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.
PPV for the detection of FRAP ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAP ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by fluorescent light (TP + FP).
95% lower one-sided confidence interval was used.
Measured: Day of Surgery (Day 1)

Timeline

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

Dec 2014Nov 2015

First posted16 Dec 2014 (estimated)
Study startDec 2014
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Ovarian CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02317705
Sponsor's protocol ID: OTL-2014-OTL38-003
Status last verified: May 2022
First submitted: 18 Nov 2014
Last updated: 21 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Al Rawahi T, Lopes AD, Bristow RE, Bryant A, Elattar A, Chattopadhyay S, Galaal K. Surgical cytoreduction for recurrent epithelial ovarian cancer. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD008765. doi: 10.1002/14651858.CD008765.pub3.
PubMed 23450588
Crane LM, Arts HJ, van Oosten M, Low PS, van der Zee AG, van Dam GM, Bart J. The effect of chemotherapy on expression of folate receptor-alpha in ovarian cancer. Cell Oncol (Dordr). 2012 Feb;35(1):9-18. doi: 10.1007/s13402-011-0052-6. Epub 2011 Jun 7.
PubMed 21647742
Ibeanu OA, Bristow RE. Predicting the outcome of cytoreductive surgery for advanced ovarian cancer: a review. Int J Gynecol Cancer. 2010 Jan;20 Suppl 1:S1-11. doi: 10.1111/IGC.0b013e3181cff38b.
PubMed 20065732
Kalli KR, Oberg AL, Keeney GL, Christianson TJ, Low PS, Knutson KL, Hartmann LC. Folate receptor alpha as a tumor target in epithelial ovarian cancer. Gynecol Oncol. 2008 Mar;108(3):619-26. doi: 10.1016/j.ygyno.2007.11.020. Epub 2008 Jan 28.
PubMed 18222534
Leamon CP, Low PS. Membrane folate-binding proteins are responsible for folate-protein conjugate endocytosis into cultured cells. Biochem J. 1993 May 1;291 ( Pt 3)(Pt 3):855-60. doi: 10.1042/bj2910855.
PubMed 8387781
Markert S, Lassmann S, Gabriel B, Klar M, Werner M, Gitsch G, Kratz F, Hasenburg A. Alpha-folate receptor expression in epithelial ovarian carcinoma and non-neoplastic ovarian tissue. Anticancer Res. 2008 Nov-Dec;28(6A):3567-72.
PubMed 19189636
Parker N, Turk MJ, Westrick E, Lewis JD, Low PS, Leamon CP. Folate receptor expression in carcinomas and normal tissues determined by a quantitative radioligand binding assay. Anal Biochem. 2005 Mar 15;338(2):284-93. doi: 10.1016/j.ab.2004.12.026.
PubMed 15745749
Ross JF, Chaudhuri PK, Ratnam M. Differential regulation of folate receptor isoforms in normal and malignant tissues in vivo and in established cell lines. Physiologic and clinical implications. Cancer. 1994 May 1;73(9):2432-43. doi: 10.1002/1097-0142(19940501)73:93.0.co;2-s.
PubMed 7513252
Shih KK, Chi DS. Maximal cytoreductive effort in epithelial ovarian cancer surgery. J Gynecol Oncol. 2010 Jun;21(2):75-80. doi: 10.3802/jgo.2010.21.2.75. Epub 2010 Jun 30.
PubMed 20613895
Toffoli G, Russo A, Gallo A, Cernigoi C, Miotti S, Sorio R, Tumolo S, Boiocchi M. Expression of folate binding protein as a prognostic factor for response to platinum-containing chemotherapy and survival in human ovarian cancer. Int J Cancer. 1998 Apr 17;79(2):121-6. doi: 10.1002/(sici)1097-0215(19980417)79:23.0.co;2-v.
PubMed 9583724
van Dam GM, Themelis G, Crane LM, Harlaar NJ, Pleijhuis RG, Kelder W, Sarantopoulos A, de Jong JS, Arts HJ, van der Zee AG, Bart J, Low PS, Ntziachristos V. Intraoperative tumor-specific fluorescence imaging in ovarian cancer by folate receptor-alpha targeting: first in-human results. Nat Med. 2011 Sep 18;17(10):1315-9. doi: 10.1038/nm.2472.
PubMed 21926976
Weitman SD, Lark RH, Coney LR, Fort DW, Frasca V, Zurawski VR Jr, Kamen BA. Distribution of the folate receptor GP38 in normal and malignant cell lines and tissues. Cancer Res. 1992 Jun 15;52(12):3396-401.
PubMed 1596899

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer
ClinicalTrials.gov ID: NCT02317705
Acronym / sponsor ID: OTL-2014-OTL38-003
Conditions: Ovarian Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: On Target Laboratories, LLCIndustry (pharma, biotech, devices)
Collaborators: SynteractHCR
Study start: Dec 2014
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 16 Dec 2014 (estimated)
Results: Posted 21 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is being done to:

test the safety of OTL38
see if OTL38 helps light up the cancer when viewed with the special camera system
test the safety of the special camera system for use along with OTL38 during surgery

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients Receiving OTL38	Experimental	Drug: OTL38, Device: Near infrared camera imaging system, Procedure: LaparotomyAll patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Female patients 18 years of age and older
Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary debulking or interval debulking surgery, and:
A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential
Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments

Key exclusion criteria (14 listed)

Previous exposure to OTL38
Known FR alpha-negative ovarian cancer
Planned surgical approach via laparoscopy or robotic surgery
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
History of anaphylactic reactions or severe allergies

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OTL38Also: OTL38 for Injection, CYTALUX™ (pafolacianine) injection	Drug	Patients Receiving OTL38
Near infrared camera imaging systemNear infrared camera imaging system	Device	Patients Receiving OTL38
Laparotomyprimary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery	Procedure or surgery	Patients Receiving OTL38

Primary outcome

Sensitivity of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.
Time frame: Day of Surgery (Day 1)
Sensitivity for the detection of folate receptor-alpha positive (FRAP) ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAO ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by the pathology/ and immunohistochemistry lab (TP+FN). 95% lower one-sided confidence interval was used.
Positive Predictive Value (PPV) of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.
Time frame: Day of Surgery (Day 1)
PPV for the detection of FRAP ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAP ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by fluorescent light (TP + FP). 95% lower one-sided confidence interval was used.

Results and safety

Results posted to the registry on 21 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OTL38 for Intra-operativeImaging of Folate Receptor-alpha Positive Ovarian Cancer	48	43

Primary outcome: Sensitivity of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.

Time frame: Day of Surgery (Day 1). Number (95% Confidence Interval). Unit: percentage of lesions

Measure	Experimental n = 29
Value	97.97 (87.75 to NA)

Population analysed: Population includes all patients who received OTL38, underwent cytoreductive surgery for sensitivity analysis, were exposed to fluorescent light using the imaging system, and had at least one FRAP target ovarian cancer lesion. Patients enrolled to the study after adequate number of lesions have been excised and submitted for pathology, and immunohistochemistry evaluation for determining sensitivity, enrolled after protocol amendment 4, were not included in the analysis population.

Primary outcome: Positive Predictive Value (PPV) of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.

Time frame: Day of Surgery (Day 1). Number (95% Confidence Interval). Unit: percentage of lesions

Measure	Experimental n = 29
Value	94.93 (86.13 to NA)

Population analysed: Population includes all patients who received OTL38, underwent cytoreductive surgery for PPV analysis, were exposed to fluorescent light using the imaging system, and had at least one FRAP target ovarian cancer lesion. Patients enrolled to the study after adequate number of lesions have been excised and submitted for pathology, and immunohistochemistry evaluation for determining PPV, enrolled after protocol amendment 4, were not included in the analysis population.

Adverse events

Time frame: Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Receiving OTL38	13 of 44 (29.5%)	44 of 44 (100%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23450588Al Rawahi T, Lopes AD, Bristow RE, Bryant A, Elattar A, Chattopadhyay S, Galaal K. Surgical cytoreduction for recurrent epithelial ovarian cancer. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD008765. doi: 10.1002/14651858.CD008765.pub3.
Background: PubMed 21647742Crane LM, Arts HJ, van Oosten M, Low PS, van der Zee AG, van Dam GM, Bart J. The effect of chemotherapy on expression of folate receptor-alpha in ovarian cancer. Cell Oncol (Dordr). 2012 Feb;35(1):9-18. doi: 10.1007/s13402-011-0052-6. Epub 2011 Jun 7.
Background: PubMed 20065732Ibeanu OA, Bristow RE. Predicting the outcome of cytoreductive surgery for advanced ovarian cancer: a review. Int J Gynecol Cancer. 2010 Jan;20 Suppl 1:S1-11. doi: 10.1111/IGC.0b013e3181cff38b.
Background: PubMed 18222534Kalli KR, Oberg AL, Keeney GL, Christianson TJ, Low PS, Knutson KL, Hartmann LC. Folate receptor alpha as a tumor target in epithelial ovarian cancer. Gynecol Oncol. 2008 Mar;108(3):619-26. doi: 10.1016/j.ygyno.2007.11.020. Epub 2008 Jan 28.
Background: PubMed 8387781Leamon CP, Low PS. Membrane folate-binding proteins are responsible for folate-protein conjugate endocytosis into cultured cells. Biochem J. 1993 May 1;291 ( Pt 3)(Pt 3):855-60. doi: 10.1042/bj2910855.
Background: PubMed 19189636Markert S, Lassmann S, Gabriel B, Klar M, Werner M, Gitsch G, Kratz F, Hasenburg A. Alpha-folate receptor expression in epithelial ovarian carcinoma and non-neoplastic ovarian tissue. Anticancer Res. 2008 Nov-Dec;28(6A):3567-72.
Background: PubMed 15745749Parker N, Turk MJ, Westrick E, Lewis JD, Low PS, Leamon CP. Folate receptor expression in carcinomas and normal tissues determined by a quantitative radioligand binding assay. Anal Biochem. 2005 Mar 15;338(2):284-93. doi: 10.1016/j.ab.2004.12.026.
Background: PubMed 7513252Ross JF, Chaudhuri PK, Ratnam M. Differential regulation of folate receptor isoforms in normal and malignant tissues in vivo and in established cell lines. Physiologic and clinical implications. Cancer. 1994 May 1;73(9):2432-43. doi: 10.1002/1097-0142(19940501)73:93.0.co;2-s.
Background: PubMed 20613895Shih KK, Chi DS. Maximal cytoreductive effort in epithelial ovarian cancer surgery. J Gynecol Oncol. 2010 Jun;21(2):75-80. doi: 10.3802/jgo.2010.21.2.75. Epub 2010 Jun 30.
Background: PubMed 9583724Toffoli G, Russo A, Gallo A, Cernigoi C, Miotti S, Sorio R, Tumolo S, Boiocchi M. Expression of folate binding protein as a prognostic factor for response to platinum-containing chemotherapy and survival in human ovarian cancer. Int J Cancer. 1998 Apr 17;79(2):121-6. doi: 10.1002/(sici)1097-0215(19980417)79:23.0.co;2-v.
Background: PubMed 21926976van Dam GM, Themelis G, Crane LM, Harlaar NJ, Pleijhuis RG, Kelder W, Sarantopoulos A, de Jong JS, Arts HJ, van der Zee AG, Bart J, Low PS, Ntziachristos V. Intraoperative tumor-specific fluorescence imaging in ovarian cancer by folate receptor-alpha targeting: first in-human results. Nat Med. 2011 Sep 18;17(10):1315-9. doi: 10.1038/nm.2472.
Background: PubMed 1596899Weitman SD, Lark RH, Coney LR, Fort DW, Frasca V, Zurawski VR Jr, Kamen BA. Distribution of the folate receptor GP38 in normal and malignant cell lines and tissues. Cancer Res. 1992 Jun 15;52(12):3396-401.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OTL38, Near infrared camera imaging system and Laparotomy in people with Ovarian Cancer, run by On Target Laboratories, LLC 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 7 inclusion and 14 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 21 Jun 2022. 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 21 Jun 2022). 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?

Sensitivity of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery. (time frame: Day of Surgery (Day 1)). 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 NCT02317705, which also lists 12 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 21 Jun 2022.