MelanomaPhase 2NCT00735332
Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma
A Phase 2 study testing TLN-232 in people with Melanoma, run by Thallion Pharmaceuticals at 4 sites in 2 countries.
Trial summary
The objective of this study is to assess the efficacy and safety of TLN-232 used to treat patients with metastatic melanoma that recur/progress after receiving first line systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- TLN-232
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2008to Oct 2010
- Phase
- Phase 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 confirmed stage IV (M1a, M1b, and M1c) unresectable metastatic melanoma (cutaneous, mucosal or acral lentiginous)
- First progression after treatment by one first line systemic therapy for metastatic melanoma (immunotherapy or targeted therapy or chemotherapy or any combination of them)
- Measurable recurrent/progressive disease by radiological scan ≤ 21 days prior to Day 1, Cycle 1
- Age ≥ 18 years
- ECOG ≤ 2
- Normal organ and marrow function as defined below:
Show all 13Show fewer
- Leukocytes ≥2.5 x 109/L
- Absolute neutrophil count ≥1.5 x 109/L
- Platelets ≥100 x 109/L
- Hemoglobin ≥100 g/L (10g/dL)
- Total bilirubin ≤1.5 X institutional ULN
- AST(SGOT)/ALT(SGPT) ≤2.5 X institutional ULN
- Creatinine ≤1.5 X institutional ULN
Who cannot join
- Patients with a life expectancy ≤ 16 weeks
- Patients with ocular melanoma
- Patients with symptomatic and/or unstable brain metastasis during the last 3 months (90 days) prior to Day 1, Cycle 1
- Patients with a history of allergic reactions or hypersensitivity to somatostatin analogues
- Patients with a documented history of HIV, active hepatitis B or C infection
- Female patients who are pregnant or lactating
Show all 9Show fewer
- Patients who are receiving hormonal therapy (with the exception of hormone replacement therapy and hormonal contraceptives), systemic steroids, immunosuppressive therapy or coumadin (low molecular weight heparin is permitted)
- Patients with grade ≥2 peripheral neuropathy (CTCAE criteria)
- Patients in whom a proper central line cannot be established
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Canada3 sites
Juravinski Cancer Centre
Hamilton, Ontario
Hôpital Notre-Dame du CHUM
Montreal, Quebec
Princess Margaret Hospital
Toronto, Ontario
About this study
Official title: A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With Metastatic Melanoma
The objective of this study is to assess the efficacy and safety of TLN-232 used to treat patients with metastatic melanoma that recur/progress after receiving first line systemic therapy.
- Conditions
- Melanoma
- Being tested
- TLN-232
- Keywords
- Melanoma, Metastatic Melanoma, Phase II, Skin Cancer
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLN-232Drug
Also called Formerly CAP-232
21 day continuous IV administration of TLN-232 followed by a 7-day recovery period
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm | Experimental | Not described Receives: Drug: TLN-232 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of TLN-232 in patients with recurrent metastatic melanoma measured by overall response rate at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1).
Measured: Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1)
Secondary outcomes (1)
To examine the safety and tolerability of TLN-232 in patients with recurrent metastatic melanoma
Measured: Maximum 13 months from date of initial infusion of TLN-232 (Day 1, Cycle 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2009
- Study completionOct 2010 (estimated)
Why it stopped: License termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thallion Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Hogg, MD, Principal investigator, Princess Margaret Hospital, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735332
- Sponsor's protocol ID
- TLN-232-202
- Status last verified
- Aug 2010
- First submitted
- 13 Aug 2008
- Last updated
- 5 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00735332
- Acronym / sponsor ID
- TLN-232-202
- Conditions
- Melanoma
- Keywords
- Melanoma, Metastatic Melanoma, Phase II, Skin Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: License termination.
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Thallion PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Oct 2010 (estimated)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the efficacy and safety of TLN-232 used to treat patients with metastatic melanoma that recur/progress after receiving first line systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm | Experimental | Drug: TLN-232 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed stage IV (M1a, M1b, and M1c) unresectable metastatic melanoma (cutaneous, mucosal or acral lentiginous)
- First progression after treatment by one first line systemic therapy for metastatic melanoma (immunotherapy or targeted therapy or chemotherapy or any combination of them)
- Measurable recurrent/progressive disease by radiological scan ≤ 21 days prior to Day 1, Cycle 1
- Age ≥ 18 years
- ECOG ≤ 2
Key exclusion criteria (9 listed)
- Patients with a life expectancy ≤ 16 weeks
- Patients with ocular melanoma
- Patients with symptomatic and/or unstable brain metastasis during the last 3 months (90 days) prior to Day 1, Cycle 1
- Patients with a history of allergic reactions or hypersensitivity to somatostatin analogues
- Patients with a documented history of HIV, active hepatitis B or C infection
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 |
|---|---|---|
| TLN-232Also: Formerly CAP-23221 day continuous IV administration of TLN-232 followed by a 7-day recovery period | Drug | Single-Arm |
Primary outcome
To assess the efficacy of TLN-232 in patients with recurrent metastatic melanoma measured by overall response rate at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1).
Time frame: Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1)
1 secondary outcome
To examine the safety and tolerability of TLN-232 in patients with recurrent metastatic melanoma
Time frame: Maximum 13 months from date of initial infusion of TLN-232 (Day 1, Cycle 1)
Results and safety
The study was stopped early (reason given: License termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2010.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
David Hogg, MD principal investigator
Princess Margaret Hospital, Toronto
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TLN-232 in people with Melanoma, run by Thallion Pharmaceuticals at 4 sites in 2 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 13 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: stopped early, as of the sponsor's last update on 5 Aug 2010. 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 Canada, 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?
The study was stopped early (reason given: License termination.). Results are not available in the source record.
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?
To assess the efficacy of TLN-232 in patients with recurrent metastatic melanoma measured by overall response rate at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1). (time frame: Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2010.